Congratulations to Vera Hollen, who is working directly with Carilion leadership on the Rural Health Transformation Grant, an initiative focused on improving health outcomes for communities across rural Virginia.

As part of the first round of funding, Virginia was awarded $189.5 million to support innovative strategies that improve healthcare access and outcomes in underserved communities. Carilion's leadership team will play an important role in identifying and evaluating opportunities to collaborate with the statewide program and advance these efforts.

To learn more about the Rural Health Transformation initiative, visit: Virginia Rural Health Transformation website.

We are grateful to Vera for her leadership and dedication to this important work. Her contributions reflect Research & Development's commitment to advancing innovative solutions that improve the health of the communities we serve.

At the heart of every research study is a person, a family, and a story. While we often celebrate new grants, publications, and scientific discoveries, it is the lives touched by research that remind us why our work matters.

In this new recurring feature, Research Matters, we will share the stories of research participants, families, investigators, and research professionals whose experiences reflect the impact of research across our communities. These stories celebrate not only scientific progress, but also the hope, courage, and partnerships that make discovery possible.

For our inaugural feature, we are honored to share the story of Danny D. a young boy who participated in a leukemia clinical trial at Carilion.

His journey is one of resilience, hope, and the extraordinary partnership between families and research teams. Recently, his family reached out with wonderful news: Danny is thriving! After completing treatment, he has finished kindergarten and is now a rising first grader. His family shared that he is reading and writing above grade level, making new friends, enjoying T-ball, and discovering a love for music.

Along with sharing this wonderful update, Danny's family expressed their heartfelt gratitude to the physicians, nurses, research staff, and care teams who supported them throughout their journey. "All of this to say, none of this would be possible without the work and care that we received at Carilion Clinic from all of you... Through every test, poke, prod and IV drip, you all carried so much love and light into the room in the absolute darkest of times."

For those who cared for him throughout his research journey, this update is a powerful reminder that every consent discussion, study visit, laboratory sample, and data entry represents much more than a research protocol. Together, these efforts contribute to discoveries that improve treatments, offer hope to families, and help shape the future of medicine.

We are deeply grateful to the Dudley family for allowing us to share a small part of their journey. Their willingness to participate in research has contributed to advances that may benefit countless children and families in the years to come.

Watch Danny's Story: See how one family's journey through leukemia treatment and clinical research became a story of hope, resilience, and gratitude.

Danny's Cancer Journey with Carilion Clinic

Behind every research study is a person, a family, and a story. Thank you to every research participant who helps move medicine forward.

Edmundo Rubio, MD, is the principal investigator for a clinical trial that may help improve early detection for current and former smokers through blood samples. This study aims to validate blood-based biomarkers for identifying heavy cigarette smokers at the highest risk of having asymptomatic early-stage lung cancer, warranting screening by low-dose CT. Learn more: https://bit.ly/48W2RnW

We are proud to recognize Saige Dagenhart, who will celebrate their one-year anniversary with Carilion on December 2, 2025. This milestone reflects Saige’s dedication and contributions to our team.

Melissa Mercure, PhD, Grant Management Administrator, was honored on Monday, November 7 at the annual Shine Awards ceremony as part of a team recognized for their outstanding work. The team received the Courage Value Award for their efforts on the Violent Injury Recovery and Support Program.

Congratulations to Dr. Cesar Bravo and Aiden Discordia for achieving the enrollment goal in the SiD study. This clinical trial is designed to evaluate the safety and performance of the Stryker Shoulder iD, a personalized shoulder implant tailored to individual patient needs. 

The team successfully enrolled 8 patients in only 6 months, ahead of schedule. We extend our sincere thanks to the entire study team for their dedication in screening and enrolling participants.

Click here to review the results!

📰 Accelerating Research: How the R&D Application Streamlines Study Activation

In the complex landscape of research, efficiency and compliance are paramount. At Carilion, the Research & Development (R&D) application and intake process exists as a powerful tool to streamline study activation—saving time, reducing administrative burden, and enabling researchers to focus on what matters most: the science.

🔍 IRB vs. R&D Approval: A Dual Pillar of Research Integrity

Before a study can launch, it must pass through two critical checkpoints: Institutional Review Board (IRB) approval and R&D approval. Though they serve distinct purposes, both are essential to ensure a study is not only ethical but also operationally viable.

Together, these approvals form a comprehensive vetting process that protects participants and ensures institutional resources are used effectively.

⚙️ The Power of the R&D Application: Behind-the-Scenes Efficiency

The R&D application is more than a form—it's a launchpad. Once submitted, it triggers a cascade of operational workflows that run concurrently, dramatically reducing activation timelines:

• ✅ Automated routing to department leadership to secure approval for resource allocation
• 📊 Feasibility assessments to gauge study viability
• 🧪 Alerts to support services (pharmacy, imaging, lab, etc.)
• 🧾 Vendor account setups and agreements (e.g., Quest Diagnostics, Dominion Pathology)
• 🖥️ Study builds in Clinical Conductor (clinical trial management software), Epic, and Ereg (electronic regulatory document software)
• 📄 Research contracts (CDAs, CTAs, grants, data use agreements, etc.)
• 💰 Budget development and funder negotiations
• 🔍 Coverage analysis to distinguish study-paid vs. routine care services
• ⚖️ Conflict of interest review
• 💡 Intellectual property identification
• 📂 Licensing for external datasets

Many of these processes are automated and occur in parallel, eliminating bottlenecks and manual follow-ups. Researchers benefit from a seamless experience, with fewer administrative hurdles and faster access to study launch.

⏱️ Downstream Benefits: Time Saved, Impact Amplified

By centralizing and automating key operational tasks, the R&D intake process transforms study activation from a fragmented journey into a coordinated sprint. The result?

• 🚀 Faster study launches
• 📉 Reduced administrative overhead
• 🧠 More time for scientific inquiry
• 🤝 Stronger collaboration across departments

In short, the R&D application is not just a process—it’s a strategic advantage.

For researchers navigating the path from concept to activation, Carilion’s R&D intake process offers clarity, speed, and support. It’s one more way we’re advancing research with purpose and precision. intake process offers clarity, speed, and support. It’s one more way we’re advancing research with purpose and precision.

SENT ON BEHALF OF RANDY HEFLIN AND THE OFFICE OF RESEARCH AND INNOVATION

Dear colleagues,

We are organizing the Proposal Development Institute (PDI) for Spring 2026 and are writing to ask you to identify early career faculty who could benefit from it. 

The purpose of the PDI program is to provide a variety of experiences that are designed to enhance the ability of tenure-track faculty and research assistant professors at Virginia Tech to successfully pursue externally funded grants and contracts to support their research and scholarly activities. 

The program is primarily designed for faculty members who are still relatively early in their development regarding the formulation of their research ideas into formal written proposals to external sponsors. The PDI program is funded through a small registration fee ($350) per selected participant, which departments and programs will commit to sponsoring by nominating their faculty members.

The PDI program will include a portfolio of activities targeting all of the participants, regardless of their affiliation. The primary workshop will occur during two all-day sessions on January 15th and 16th, 2026. In-person participation is strongly encouraged, but Zoom will also be available for those who are unable to be in Blacksburg on those days.

Additional supplementary meetings of PDI will occur every few weeks on Wednesdays 4-5 pm from January 28th through April 29th, 2026 in hybrid (Zoom and in-person) format. 

The PDI webpage has more details about the program. 

Please email to Eleanor Nelsen (enelsen@vt.edu) the names and email addresses of the early career faculty in your program that you would like to nominate for this program by December 10th.

Should you have any questions, please feel free to contact me at rheflin@vt.edu or 540-231-3899. 

Thank you and best regards,

Randy Heflin and Eleanor Nelsen

Workday's Post Award Management module is designed to manage research awards and other types of sponsored projects.  As we prepare to launch the Post Award Management module, several key activities are underway to support a smooth transition and ensure that all necessary tools and resources are in place.

·  FY2025 financial activity will continue to be recorded in Lawson through September 30. Fiscal year-end close will occur by mid-October, which must be completed before active awards can be imported into Workday.

·  In early November, life-to-date financial data for all sponsored projects will be loaded and validated in Workday. This foundational step will ensure accuracy across reporting systems.

·  Reporting dashboards are currently in development and will undergo thorough testing to confirm accurate data loading. Once finalized, these dashboards will be embedded into training modules and job aids, offering clear, visual guidance for managing sponsored projects.

·  In late November, a Post Award Management e-learning module will be released in Workday. This self-paced training will cover essential aspects of post-award project management, including financial oversight, compliance, and reporting.

·  Supporting documentation, including job aids, will also be available in the Employee Center to reinforce training content and provide ongoing reference materials.

 Thank you for your continued support as we enhance our Post Award Management tools and training resources.

As a member of the U.S. Army, Dr. Davin Combs developed a passion for working with emergency medical service providers such as fire rescue teams and law enforcement officers. His military service in security roles allowed him the opportunity to work closely with these groups, and at times, to develop and provide training. Fast-forward to today where he brought his experiences and ideas with him to his residency training in emergency medicine here at Carilion Clinic.

Dr. Combs spent a significant amount of time during the first two years of his emergency medicine residency working with his faculty mentor, Dr. Hayley Rose-Inman, to develop a training course for local community law enforcement officers to teach them basic life-saving interventions that are helpful in what’s known as ‘tactical emergency casualty care’ or TECC. This training was provided to more than 150 local law enforcement officers. He took this work a step further and collaborated with Nate Jones and the Human Factors team to create and execute a high-fidelity, simulated mass casualty incident (MCI) that included an active shooter threat element. Dr. Combs used this simulation even to test whether the START triage model or the National Health Service Ten Second Triage (TST) model is more appropriate for law enforcement officers to use under an active threat MCI event. Currently, the START model is the most widely used in the United States, but it may not be the best choice given the limit clinical background of most law enforcement officers. He hopes that the data from his research can be replicated at other sites and ultimately used to change practice standards for teams responding to MCIs.

The MCI simulation was held in June with Roanoke-based law enforcement and rescue squad participation. The study team has submitted this initial data for publication, and Dr. Combs is pursuing grant funding to expand this work to other sites, including a partnership with the University of Michigan Medical School and Dr. Florian Schmitzberger. Dr. Combs is also one of the Department of Emergency Medicine’s Chief Residents and will be applying to fellowships this fall, including the Virginia Tech Carilion Emergency Services Fellowship program.

Clinical research is a highly regulated, fast-paced field requiring skilled and flexible resources to provide efficient study startup, compliant study conduct, and support for busy research investigators. The CRC/RS Pool is a team of trained professionals able to manage a wide range of customizable responsibilities to best fit the needs of your research team.

About:

Due to the complexities of clinical research, study teams utilizing experienced staff can manage study processes efficiently and respond quickly to the ever-evolving clinical research landscape. Hiring CRCs and regulatory staff requires significant time and investment. The CRC/RS pool provides on-demand, reliable support. All CRC/RS staff have received full onboarding and training prior to receiving assignments. Continuing education is provided to remain current with regulations, policies, SOPs, and best practices.

In addition to CRC and Regulatory Specialist competency verification, staff have completed the following training: Human Subject Research Protections, Good Clinical Practices (GCP), Biomedical Researcher, eReg, Clinical Conductor CTMS, Epic, IATA, and clinical skills (i.e., vital signs, ECG, and phlebotomy, as needed). Our team is proficient with REDCap and multiple EDC systems.  The CRC/RS pool has diverse experience working with multiple sponsors and systems across Carilion Clinic.

Services:

The CRC/RS pool can provide the following support services, customized to fit specific project needs:

·         End-to-end project support (study startup, implementation, coordination and closeout, including regulatory and IRB process support)

• Temporary CRC coverage for employees on leave or during periods of turnover
• Supplemental support during busy study periods (enrollment push, etc.)
• CRC/RS support for PIs who do not have funding for a full-time CRC or Regulatory Specialist

Support requests can be full-service or a la carte, including:

Clinical Coordination

• Subject prescreening and subject recruitment
• Obtaining informed consent
• Data collection
• CRF completion/query resolution
• Specimen collection/processing
• Receipt and inventory of study supplies
• Central imaging uploads
• Study visit completion in accordance with study protocol
• AE and SAE reporting
• Ongoing liaison for all subject-related communications with PI/study team
• Ongoing liaison with external sponsor and PI/study team
• Monitoring/audit visit preparation and management

IRB & Regulatory

• Preparation and submission of IRB applications in PRIS3M, including stipulation responses
• Customization of consent form templates with site-specific requirements
• Preparation of subject recruitment materials
• Preparation and submission of regulatory documents (e.g. 1572, Financial Disclosure Forms, CVs, etc.)
• Preparation and submission of amendments to the IRB including revisions to the ICF
• Regulatory document preparation (Investigator Site File)
• Preparation of study documents (e.g. source documents, participant visit packets, dosing cards, etc.)
• Monitoring/audit visit preparation and management
• Study archival

Payment and Fees:

CRC/RS Pool staff are available as a fee-for-service program. This service can be requested by any Carilion Clinic investigator.

• CRC/RS support is charged at an hourly rate, inclusive of benefits
• CRC/RS time is tracked via effort reporting and charged to the project activity code and/or designated cost center on a monthly basis
• For studies in start-up, time will be captured via effort report under ‘non-sponsored’ effort until the creation of a project activity code. At the time of activity code creation, the charges will be transferred to the project activity code or designated cost center.
• Based on the requested services, R&D can provide estimated budgets to investigators for planning purposes
• Active RAP grant recipients receive this service as part of the total award
• Services are provided during normal business hours (M-F, 8am-5pm)
• Time allowed per investigator or per study will be monitored and adjusted based on need and overall demand for service
• Requests will be managed on a first-come, first-served basis, contingent upon resource availability

Request Process:

Complete the form linked below to request central CRC/RS support services:

CRC/RS Request Form

Prior to beginning a work assignment, the assigned staff will need to complete all study-specific protocol training. Additionally, a study kickoff meeting may be scheduled with the study team in order to ensure there is a clear understanding of expectations and scope of work.

If central support is no longer needed, the assigned CRC/RS Pool team member will assist with the transition process and will continue providing support until the transition is complete.

Research at Carilion Clinic is growing at an unprecedented pace. In 2024 alone, over 200 Carilion physicians collaborated on more than 140 clinical trials across 20+ medical and surgical specialties, securing $2.7 million in new trial awards and $14 million in new grant funding​. With this remarkable momentum, Carilion is committed to ensuring that research continues to thrive with structure, strategy, and impact.

To guide this growth, Carilion Medical Center has launched a new Research Governance Structure centered around the Executive Research Council (ERC). The ERC will lead the strategic direction of Carilion’s research enterprise, foster innovation, and strengthen partnerships with key collaborators like Radford University, Virginia Tech (VT), the Virginia Tech Carilion School of Medicine, and the Fralin Biomedical Research Institute.

Chaired by Dr. Robert Trestman, the Executive Research Sponsor, the ERC includes Dr. Michael Wilson, the Associate Institutional Research Officer, Department Chairs, Center Directors, faculty investigators, community representatives, and research leaders from our academic partners. These members include Aileen Helsel, Suzanne Kraemer, Chuck Sawyers, Steve Morgan, Kristin Meador, John Jane, Lana Wahid, Cynthia Lawrence, Michael Wilson, Donna Rhodes, Randy Heflin (VT), and Leslie LaConte (VT). Together, they will oversee research operations, align efforts across departments, and champion new opportunities for discovery and innovation.

Six Committees: Guiding Research with Focused Expertise

To support the ERC’s mission and ensure comprehensive governance, six specialized committees have been established. Each committee is tasked with a specific charge, ensuring thorough oversight and advancement of Carilion’s research enterprise:

1. Education and Faculty Development

• Chair: Donna Rhodes, MA
• Charge: Ensure all research-involved investigators and staff understand their roles and responsibilities and support the growth and development of investigators.
• Focus: Training, mentorship, and professional development for research staff and faculty.

2. Innovation and Commercialization

• Chair: Aileen Helsel, PhD
• Charge: Coordinate intellectual innovation, leading to patents, products, and licensing ventures aligned with Carilion’s mission.
• Focus: Intellectual property, technology transfer, and fostering partnerships for commercialization.

3. Health Systems and Implementation Research

• Chair: John Epling, MD
• Charge: Align and coordinate implementation science research with Carilion’s disease-specific research areas and quality, patient safety, and learning health system priorities.
• Focus: Translating research into practice to improve patient outcomes and operational efficiency.

4. Operations and Finance

• Chair: Chuck Sawyers, MBA
• Charge: Optimize institutional infrastructure, workflows, and financial models across all research endeavors. Evaluate and manage financial agreements with external partners.
• Focus: Resource allocation, budgeting, and operational support for research growth.

5. Data-Sharing Technology and Informatics

• Chair: Steve Morgan, MD
• Charge: Ensure secure, accessible, and optimized data-sharing technology to support and expand research within Carilion and with partners.
• Focus: Information security, analytics, and technology infrastructure for research.

6. Compliance Oversight

• Chair: Kristin Meador, MHA
• Charge: Ensure all research complies with federal and state regulations, institutional policies, and Institutional Review Board approvals.
• Focus: Regulatory compliance, risk management, and quality assurance.

Each committee will meet monthly and collaborate closely with the ERC, ensuring that research initiatives are strategically aligned, responsibly managed, and primed for expansion.

At Carilion, we believe research is not just about discovery—it’s about making a meaningful difference for our patients and communities. With the new Executive Research Council and committee structure in place, Carilion Clinic is poised to take research to new heights, creating a future where innovation drives better health for all.

The mission of Carilion’s Basic Science Research Lab (BSRL) is to create an environment that promotes the success of our researchers.

Most of the bench research in the BSRL belongs to two main focal areas: antimicrobial resistance and biofilms. We increasingly employ a One Health perspective. Dr. Jayasimha Rao is our senior researcher. Dr. Mark Frazier develops, conducts and assists with research. Dr. Ellie Nowak, Infectious Diseases physician, provides critical research capabilities and insights. Our lab works with Carilion Clinical Research staff, Carilion physicians and staff, Virginia Tech Carilion School of Medicine students, Radford University Carilion faculty and students, Governor’s School students, and others.

Current projects include

• One Health: Evaluating antimicrobial resistance gene patterns in canine and human urine E. coli, Development of a canine model of recurrent uropathogenic E. coli infection for evaluation of a novel biologic therapeutic
• Designing Peptide Nucleic Acids (PNAs) to reduce the occurrence of catheter-associated biofilms
• Using histotripsy to disrupt and prevent biofilm formation in catheters; translational research with bedside applications
• Local Wastewater-Based Epidemiology Pilot to determine presence and usefulness of microbial and antimicrobial targets significant to local public health
• Analysis of Acinetobacter isolates for antimicrobial resistance gene targets
• Investigation of Gram positive bacteria for biofilm formation and using natural enzymes and PNAs to affect formation
• Gut-Brain connection in C. difficile infections in the elderly
• Analyzing serum samples for neurovascular makers of traumatic brain injury
• Analyzing serum samples for vascular markers of stroke
• Maintaining Carilion-VT shared Neurosurgery Biorepository
• Processing blood and body fluids for clinical research

Projects under development include but are not limited to

• Evaluation of phage target in Providentia
• Phages in local waterways
• Projects with VTCSOM students

1. Development of a field-based rapid test for Mycobacterium species
2. Using novel focused ultrasound device for DNA extraction
3. Using phone-based interface to evaluate patient and environmental multidrug resistance data
4. Employing AI to detect multidrug resistant genes
5. Addressing biofilm formation in ventriculoperitoneal shunts
6. Investigation of Staphylococcus mediated biofilms to determine effective means of disruption

2024 Posters Presented 

1. Lauren Luther, Kathleen Linsenman, Kaylin Young, Troy Stallard, Lia W. Lehrer, BS, Nihita Kamireddy, Susan A. Tolliver, MBA, MT(ASCP)., Sara Reed Houser, MS., Jayasimha Rao, PhD, MVPHA, FVPHA. (2024) Pilot study utilizing wastewater-based epidemiology to determine presence of gram-negative enterobacterial targets in Southwest Virginia sewersheds [Poster presentation]. Carilion Research Day, Roanoke, VA.
2. Stevens, J. M., East, B. H., Frazier, M. W., Rogers, R. L., Lehrer, L. W., Tolliver, S. A., & Rao, J. (2024, October 11). Analysis of Community Wastewater Samples for the Presence of Antimicrobial Resistance Gene Targets [Poster presentation]. American Society for Microbiology Virginia Branch Meeting, Blacksburg, VA.
3. Lehrer, L., W., Linsenman, K., Stallard, T., Luther, L., Young, K., Kamireddy, N., Rogers, R. L., Tolliver, S., Reed Houser, S., & Rao, J. (2024, October 15). Pilot Study Utilizing Wastewater-Based Epidemiology to Determine Presence of Gram-Negative Enterobacterial Targets in Southwest Virginia Sewersheds [Poster presentation]. Infectious Diseases Society of America Conference, Los Angeles, CA.
4. Hannah Karp, Elizabeth Nowak, Gillian Su, Nihan Akguc, Michael Schulz, Nammalwar Sriranganathan, Jayasimha Rao. (2024, October 15). Novel Antisense Wide-Ragne Peptide Nucleic Acids Coated on Polystyrene Plates to Prevent Bacterial Biofilm. [Poster presentation]. Infectious Diseases Society of America Conference, Los Angeles, CA.
5. Gillian Su, Hannah Karp, Jayasimha Rao, Elizabeth Nowak, Nammalwar Sriranganathan, Michael Schulz. (2024, October 15). Gentamicin-Releasing Urinary Catheter for Preventing Catheter-Related Infections. [Poster presentation]. Infectious Diseases Society of America Conference, Los Angeles, CA.
6. Reed Houser, S., Rogers, R. L., Stevens, J., Lehrer, L. W., Tolliver, S., & Rao, J. (2024, September 19). Pilot Study Utilizing Wastewater-Based Epidemiology in Southwest Virginia Sewersheds [Oral presentation]. Virginia Public Health Association Conference, Richmond, VA.

Recent Publications

1. Sahanapriya Gubbewad, Jayashima Rao, Meenakshi S Devarmani, Sujatha Ingin Shetty, Chandrakanth Kelmani R. Prevalence of bacterial vaginosis: Assessment of sociodemographic characteristics among the reproductive age women. Indian Journal of Applied and Pure Biology. Accepted for the publication in Volume 40 number 02, May 2025 (IJAPB).
2. Lia Willow Lehrer, Anna Marie Lewis, Susan Tolliver, Marcia Degen, Rekha Singh, Sara Houser, Jayasimha Rao. An Evaluation of a New Rapid qPCR Test for the Detection of 2019-Novel Coronavirus Nucleocapsid (N1) Gene in Wastewater in Roanoke and Salem VA Sewersheds. Journal of Water and Health (2024) 22 (8): 1419–1428, doi: 10.2166/wh.2024.085.
3. Peter Vikesland, Ayella Maile-Moskowitz, Connor Brown, Monjura Rumi, Nazifa Moumi, Haniyyah Majeed, Carla Finkielstein, Alessandro Ceci, Raul Gonzalez, Kang Xia, Lauren McDaniel, Anthony Baffoe-Bonnie, Jayasimha Rao, Liqing Zhang, Amy Pruden. Can Wastewater-based Surveillance Relate Antimicrobial Use to Resistance Patterns? Metagenomic Analysis of Two Neighboring Treatment Plants, 31 May 2024, PREPRINT (Version 1) available at Research Square [https://doi.org/10.21203/rs.3.rs-4420801/v1]
4. Binuk Samarasinghe, Kaung Lin, Christopher Blankenship, Thomas Ausburne, Kathleen Linesman, Jayasimha Rao, and Chet Bhatta. (2023). The absence of nosemosis in eastern bumblebees (Bombus impatiens) from regions of Roanoke and New River Valley. Banisteria, the natural history of Virginia. 57: 127–136. https://virginianaturalhistorysociety.com/2023/07/11/number-57-2023/.
5. Ryan Morse, Christopher Childers, Elizabeth Nowak, Jayasimha Rao and Eli Vlaisavljevich. Catheter-Based Medical Device Biofilm Ablation Using Histotripsy: A Parameter Study.  Ultrasound in Medicine & Biology, 2023-09-01, Volume 49, Issue 9, Pages 2152-2159. https://doi.org/10.1016/j.ultrasmedbio.2023.06.010
6. Jayasimha Rao, Nicholas K. Stornelli, Nathan A. Everson, Lauren F. McDaniel, Mariana Gomez De La Espriella, Jason R. Faulhaber, S. Michelle Todd, Kevin K. Lahmers, and Roderick V. Jensen. (2022). Complete Genome Sequence of Providencia stuartii CMC-4104, isolated from a human splenic abscess, containing multiple copies of NDM-1 and PER-1 carbapenem resistance genes. Microbiol Resour Announc. Aug 4;e0051422. https://doi.org/10.1128/mra.00514-22. Infectious Diseases, Carilion Clinic and the Fralin Life Science Institute, VT, and FDA CVM Vet-LIRN Veterinary Diagnostic Laboratory Program Infrastructure Grant

2024 - Abstracts Accepted for National Conferences

1. Hannah Karp, Elizabeth Nowak, Gillian Su, Nihan Akguc Col, Michael Schulz, Nammalwar Sriranganathan, and Jayasimha Rao. Novel Antisense Wide-Range Peptide Nucleic Acids Coated on Polystyrene Plates to Prevent Bacterial Biofilm.  IDWeek 2024, October 16-19, 2024, at the Los Angeles Convention Center in Los Angeles, CA. Poster Session Title: Novel Agents. Friday October 18, 2024 Time: 12:15 PM - 1:30 PM Pacific Time Location: Hall J & K. Submission ID: 1804748
2. Gillian Su, Hannah Karp, Michael Schulz, Jayasimha Rao, Elizabeth Nowak, Nammalwar Sriranganathan, Gentamicin-releasing polydopamine catheter coating to prevent urinary catheter-related infections. IDWeek 2024, October 16-19, 2024, at the Los Angeles Convention Center in Los Angeles, CA. Poster Session Title: Novel Agents. Friday October 18, 2024, Time:  12:15 PM - 1:30 PM Pacific Time and Location: Hall J & K. Submission ID: 1829299H.
3. Lia W. Lehrer, Kathleen Linsenman, Troy Stallard, Lauren Luther, Kaylin Young, Nihita Kamireddy, Susan A. Tolliver, Sara Reed Houser, and Jayasimha Rao. Pilot Study Utilizing Wastewater-Based Epidemiology to Determine Presence of Gram-Negative Enterobacterial Targets in Southwest Virginia Sewersheds. IDWeek 2024, October 16-19, 2024, at the Los Angeles Convention Center in Los Angeles, CA. Poster Session Title: Public Health, Friday October 18, 2024, Time:  12:15 PM - 1:30 PM Pacific Time and Location: Hall J & K Submission ID: 1825668.
4. Justin Howe, Ryan Morse, Jayasimha Rao, Eli Vlaisavljevich. Histotripsy Treatment of Biofilms on Orthopedic Implants: In Vitro Feasibility Study using Cobalt-Chrome and Titanium Surgical Implant Materials. Histotripsy Symposium 2024.

Congratulations to VTCSOM student, Lili Ladner, whose work in the BSRL is included in Endothelial deletion of EPH receptor A4 alters single-cell profile and Tie2/Akap12 signaling to preserve blood–brain barrier integrity, October 5, 2023,120 (41) e2204700120: https://doi.org/10.1073/pnas.2204700120

Amgen announced new data demonstrating that adding BLINCYTO® (blinatumomab) to chemotherapy significantly improves disease-free survival in newly diagnosed pediatric patients with National Cancer Institute (NCI) standard risk pediatric B-cell acute lymphoblastic leukemia (B-ALL). The data are from a Phase 3 study (AALL1731) conducted by the Children’s Oncology Group. Dr. Glenn Edwards, the Section Chief of Pediatric Hematology/Oncology was the Children's Oncology Group's Principal Investigator for Carilion Clinic. Dr. Edwards has over 30 years of clinical experience and is the PI of numerous pediatric oncology clinical trials. The results from AALL1731 were simultaneously published in the New England Journal of Medicine and were presented at the 66th American Society of Hematology Annual Meeting & Exposition in San Diego. COG is an NCI-funded cooperative group and compromised of over 200 member institutions. The vast majority of COG institutions activated and enrolled on AALL1731.

The Children’s Oncology Group (COG) – COG (childrensoncologygroup.org), a member of the NCI National Clinical Trials Network (NCTN), is the world’s largest organization devoted exclusively to childhood and adolescent cancer research. COG unites over 10,000 experts in childhood cancer at more than 200 leading children’s hospitals, universities, and cancer centers across North America, Australia, New Zealand, and Saudi Arabia in the fight against childhood cancer. Today, more than 80% of the 15,000 children and adolescents diagnosed with cancer each year in the United States are cared for at COG member institutions. Research performed by COG institutions over the past 50 years has transformed childhood cancer from a virtually incurable disease to one with a combined 5-year survival rate of 86%. COG’s mission is to improve the cure rate and outcomes for all children with cancer.

The Family and Community Medicine Research Group (FCMRG) had 10 abstracts accepted to the 52nd Annual Meeting of the North American Primary Care Research Group (NAPCRG) in Quebec City, Canada in November. Congratulations to FCM Research Coordinator, Emily Cox, MPH, MS, RD, CHES, for being selected as top 10 in her submission category.

FCMRG:

John Epling, MD, MSEd, Vice Chair for Research and Population Health: Multimodal practice change intervention utilizing population health managers (PHMs) to reduce utilization for patients with chronic obstructive pulmonary disease (COPD) (poster)
Michelle Rockwell, PhD, RD, Director of Research, FCM: Patient experiences with sludge in the colorectal cancer process (oral presentation); De-implementation of high-risk NSAIDs in primary care (poster)
Beth Polk, MD, FAAFP, dipABLM: Enhancing and Evaluating a Lifestyle Medicine Clinic in Southwest Virginia (poster)
Emily Cox, MPH, MS, RD, CHES, Health Services Research Coordinator: Patient Perceptions of a Lifestyle Medicine Clinic in Southwest Virginia (poster, presentation)

VTCSOM student mentees:

Matthew Vinson (M4): The Effectiveness of a Theory-Driven Educational Video in Reducing High-Risk Over-The-Counter Nonsteroidal Anti-Inflammatory Drug (NSAID) Use (poster)
Nancy Wu, MS (M4): Evaluating the Implementation of a Community Health Worker Program and its Impacts on Hypertension and Type 2 Diabetes Outcomes in Primary Care Settings Using RE-AIM (poster)
Brianna Chang, MSc (M3): Interactions of Multiple Chronic Conditions and Sludge on Treatment Burden and Delayed/Skipped Colorectal Cancer Screenings (poster)
Isaiah Yim (M3): Evaluating the Consequences of Switching from Long-Term Opioids to Long-Term NSAIDs in Patients with Chronic Kidney Disease (poster)

TBMH student mentee:

Jamie Turner, MPH: A Difference-in-Differences Analysis of Opioid Prescribing for Acute Pain During the COVID-19 Pandemic in Virginia (poster)

Research, along with patient care and education, is one of the three pillars supporting our mission to improve the health of the communities we serve. Moreover, as an organization, it is imperative that research is conducted to the highest ethical standards and that all patients have access to research opportunities. Presently, most patients learn about research only from their personal health care provider. If not informed by their health care provider, they must navigate our website and determine their suitability for participation using their own judgment and knowledge of research opportunities. This scenario disproportionately skews research participation toward the most informed individuals and/or those under the care of physicians who actively seek research opportunities for their patients.

Recently, a group of stakeholders from Research, Compliance, Health Analytics, Legal, and Marketing collaborated to develop specific research language for our general consent-to-treat form. This language informs patients that they may be contacted for voluntary participation in research studies conducted by Carilion Clinic health care providers. Patients will have the option to “opt out” of these requests if they wish. Opting out will have no effect on their current treatment or their relationship with their physicians. Additionally, their physicians may continue to discuss research opportunities through the standard patient-physician relationship.

To implement this new paradigm, the team developed consent language, a process for documenting opt-out preferences in EPIC, and a call line/email inbox to address patient questions. Both English and Spanish versions of the consent form were created. The team is also developing a communication strategy for the broader community, utilizing a variety of platforms.

In summary, stakeholders from various functional areas collaborated to thoughtfully draft a plan ensuring that research opportunities are accessible to all patients, regardless of barriers such as physical location, socioeconomic status, or their provider’s awareness of available studies. The team also worked through the necessary approval processes to bring this initiative to fruition. While the foundational aspects of the project have been accomplished, the team is committed to introducing this paradigm strategically and diligently to ensure patients, the community, and health care providers are informed and engaged.

A social media campaign will include the message below, to be posted on the Carilion Clinic Facebook page, as well as a YouTube video and FAQ.

Your health matters, and so does your voice in research. Our Research Outreach team contacts people who’ve received care from us about research studies they may be eligible to take part in. This gives everyone in our community a chance to be represented in research. If you don’t want to be contacted by our Research Outreach team, you can opt out by calling 540-224-6744 or emailing optoutresearch@carilionclinic.org.  Opting out does not prevent your healthcare team from talking with you about research opportunities that may be relevant to your care or health condition. 

Dr. Rukstalis, a highly respected urologist and surgeon scientist, has spent his career focused on offering cutting-edge care and treatments to improve the well-being of his patients. As one of two lead investigators in the Expander-2 clinical trial, he is spearheading research on an innovative surgical approach for treating lower urinary tract symptoms caused by Benign Prostatic Hyperplasia (BPH). This condition affects many men as they age, and the trial offers hope for more effective relief.
If you're curious to learn more about prostate health and how BPH impacts the body, we invite you to explore this Health and Wellness article, which provides deeper insight into these topics. For those interested in the details of the Expander-2 clinical trial, additional information is available on our Clinical Trials page.

We encourage proposals that align with our Vision 2025 Research and Innovation goals, which include:

• Expanding, designing, and investing in future care delivery models
• Growing and investing in clinical platforms to provide cutting-edge treatments
• Strengthening academic partnerships with:
  • Virginia Tech
  • Fralin Biomedical Research Institute at VTC
  • Radford University Carilion

While all rigorous research proposals are welcome, we especially encourage projects that align with these strategic areas of focus.

Important Dates and Funding Information:

Tier I Applications:

• Submission Deadline: Monday, December 2, 2024, by 5 p.m. EST
• Award Notification: January 22, 2025
• Funding: Up to $40,000

Tier II and III Applications:

• Submission Deadline: Monday, December 2, 2024, by 5 p.m. EST
• Award Notification: January 22, 2025
• Funding: Up to $15,000 (Tier II) and $2,500 (Tier III)

For detailed guidelines, please refer to the RAP25 instructions below or visit our R&D website. We look forward to your innovative contributions to Carilion’s mission of advancing healthcare, education, and research!

For questions and inquiries, contact Melissa Mercure at mzmercure@carilionclinic.org; Vera Hollen at vlhollen@carilionclinic.org;  Francis Farrell at fxfarrell@carilionclinic.org or research@carilionclinic.org.

Announcing Whole Health Consortium’s 2024-2025 Seed Grant RFA
 

The Whole Health Consortium (WHC) at Virginia Tech is pleased to announce its annual funding opportunity that aligns with our overarching goal of investigating equitable health and well-being solutions that support people and their communities to pursue meaningful lives.   

The WHC aims to lead a paradigm shift toward a whole-health approach to well-being by addressing health integrated across levels—from molecular, behavioral, social, environmental, and societal—and prioritize a proactive model of disease prevention and well-being of individuals and communities. This vision is rooted in a commitment to advancing transdisciplinary research and calls on expertise across and beyond the university to inform equitable solutions for holistic health and well-being.   

This year we are encouraging community-collaborative research that explores health on multiple levels, ranging from molecular and cellular mechanisms to individual behaviors and lifestyles to social determinants, cultural influences, and physical/environmental factors.  Key priority areas include addressing mental health, overmedication, substance use, and the development of trauma-informed communities.  

We will award 2-3 grants of up to $40,000 in Track 1 and 4-6 grants of up to $10,000 in Track 2, with the latter generously funded in collaboration with Carilion Clinic. 

For more details and to access the Request for Proposals, please visit here. Please note that the Letter of Intent (LOI) deadline is Friday, September 13 at noon.   

Have questions about the Seed Grants?  Need Collaborators?    

Attend the Fall Virtual Kickoff: Seed Grant Info Session & Networking  

Date: Wednesday, September 4, 2024  

Time: 4 PM  

Details: Get an overview of the 2024-2025 Seed Grant Program and take the opportunity to seek collaborations and network with fellow members. Registration is required: Register here.

The 2024 Cure Kids Cancer Radiothon, hosted by 94.9 Star Country, took place on Friday, August 9th. This annual fundraiser benefits Carilion Children’s Pediatric Hematology and Oncology Clinic and has, over the past fifteen years, raised more than $2.7 million to support pediatric cancer treatment in the Roanoke Valley. This year alone, the event raised an impressive $131,000.

The Radiothon raises essential funds and heightens awareness of the clinic's mission by sharing powerful patient testimonies that highlight the clinic's profound impact on the lives of children and their families. All donations directly support the clinic’s vital services, ensuring that young patients receive the necessary care.

In the past, funds have contributed to creating the clinic's library, which offers a diverse and inclusive selection of books for parents and children—many of which reflect the unique experiences of young patients. Additionally, donations help meet broader clinic needs, from staffing to essential resources, further enhancing the level of care provided.

Through the continued generosity of the community, the Cure Kids Cancer Radiothon plays a crucial role in supporting Carilion Children’s mission to offer hope and healing to families facing the challenges of pediatric cancer. The funds raised not only sustain the clinic’s operations but also bring comfort and encouragement to those who need it most, making a lasting difference in the lives of countless children. 

To learn more about Pediatric clinical trials at Carilion visit our website: Pediatric Cancer Research | Carilion Clinic

On July 9, 2024, healthcare practitioners from across the Commonwealth and beyond gathered for “One Health, One Voice for Antimicrobial Stewardship” sponsored by Carilion’s Infectious Diseases Department and Virginia-Maryland College of Veterinary Medicine, Virginia Tech.  An introduction to One Health was followed by a presentation that illustrated humans and their animals share organisms and antimicrobial genes. Epidemiologists, public health leaders, pharmacists, veterinarians, physicians, basic scientists, and others addressed the shared challenges and unique differences in antimicrobial stewardship across human and veterinary medicine. Ideas were generated to support antimicrobial stewardship which will improve the health of all the communities we serve regardless of species. A total of 35 attended including 11 presenters. This conference was funded by SHARP grant, the Virginia Health Department.

Topics included:             

Perspectives on a One Health approach to antimicrobial resistance           

o   Dr. Cassidy Rist, Associate Director, Center for Public and Corporate Veterinary Medicine, Virginia Maryland College of Veterinary Medicine

Do people and pets share antimicrobial-resistant pathogens in southwestern Virginia?

o   Dr. Tessa LeCuyer, Veterinary Clinical Microbiologist, School of Veterinary Medicine, University of California Davis

o   Dr. Jay Rao, Associate Professor, Department of Infectious Disease, Carilion Clinic

o   Dr. Rick Jenssen, Associate Professor Emeritus, Department of Biological Sciences, Virginia Tech

Public health priorities for antimicrobial stewardship in Virginia

o   Dr. Shaina Bernard, An􀆟microbial Resistance Coordinator for the Virginia Department of Health

Veterinary profession priorities for antimicrobial stewardship

o   Dr. Cooper Brookshire, Assistant Clinical Professor, Mississippi State University

Educational activities to support One Health, One Voice for AMS in Virginia

o   Dr. Cassidy Rist, Associate Director, Center for Public and Corporate Veterinary Medicine, Virginia Maryland College of Veterinary Medicine

The conference ended with a panel discussion moderated by Dr. Cassidy Rist. The panel discussion was interactive with robust involvement of the attendees. Panelists included: Dr. Cooper Brookshire, Assistant Clinical Professor, Mississippi State University; Dr. Bobbie Conner, Clinical Associate Professor, Emergency and Critical Care Medicine, VMCVM; Dr. Michael Nappier, Clinical Associate Professor, Community Practice, VMCVM; Dr. Shaina Bernard, Antimicrobial Resistance Coordinator for the Virginia Department of Health; Dr. Richard Bryant, Veterinarian and Owner, Salem Animal Hospital; Dr Ryan Fulton, Pediatrician, Carilion Children’s, Daleville; Dr. Lauren McDaniel, Clinical Pharmacy Specialist, Infectious Diseases, Carilion Clinic.

Over four years, the study team enrolled 76 primary care practices across Virginia who collectively screened nearly 115, 000 patients for unhealthy alcohol use. There was also evidence of improvements in practice-based counseling and medication interventions, in addition to referrals for further treatment. A secondary analysis of study data revealed that, although patients with physical and mental health conditions were significantly more likely to screen positive for unhealthy alcohol use, but were over 10% less likely to be screened.

John Epling, MD, MSEd served as a Regional Lead for the study and Michelle Rockwell, PhD served as Practice Facilitator. About 20 Carilion primary care practices participated in the project. The study was part of a national $18 million initiative sponsored by the Agency for Healthcare Research and Quality.

For more information on unhealthy alcohol use, see:

Dr. Epling youtube alcohol

https://rethinkingdrinking.niaaa.nih.gov/

For more information on screening and management for unhealthy alcohol use, see:

https://uauvirginia.squarespace.com/

https://www.samhsa.gov/sbirt

For more information about the study, see:

JAMA Health Forum study: read the article

https://www.ahrq.gov/evidencenow/projects/alcohol/index.html

https://uauvirginia.squarespace.com/results

To learn more about Family & Community Medicine research visit our website: Family Medicine Research | Carilion Clinic

Jointly provided by Carilion Clinic and the Virginia-Maryland College of Veterinary Medicine, this free activity will focus on One Health aspects of antimicrobial resistance and antimicrobial stewardship that span across medical disciplines.

Target Audience: 

Physicians.  Other healthcare professionals will also benefit from this educational opportunity.

Conference Objectives:

1. Contrast antimicrobial resistance data in animals to data from people in the same region
2. Apply antimicrobial use communication strategies to their area of medical practice
3. Compare antimicrobial stewardship recommendations across medical disciplines
4. Summarize the shared challenges and unique differences in antimicrobial stewardship implementation across human and veterinary medical disciplines
5. Explain how antimicrobial resistance and stewardship in your discipline affects healthcare delivery in other fields
6. Select antimicrobial stewardship practices to implement in your medical discipline

Registration Information:

Go to https://redcapweb.carilionclinic.org/redcap/surveys/?s=H3L8XY9APJWAR3XM

NOTE:   Registration is free.  Due to the Stark Law, AMA PRA Category 1 Credit™ will be provided to Carilion Clinic healthcare professionals only. (Stark Law is a set of United States federal laws that prohibit self-referral, specifically a referral by a physician of a Medicare or Medicaid patient to an entity for the provision of designated health services (“DHS”) if the physician or an immediate family member has a financial relationship with that entity).

CME Credits:

The Medical Society of Virginia is a member of the Southern States CME Collaborative, an ACCME recognized accreditor. This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Southern States CME Collaborative (SSCC) through the joint providership of Carilion Clinic’s CME Program and Carilion Clinic Infectious Diseases. Carilion Clinic’s CME Program is accredited by the SSCC to provide continuing medical education for physicians. Carilion Clinic’s CME Program designates this live activity for a maximum of 2.67 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

One Health, One Voice for Antimicrobial Stewardship

Carilion Roanoke Community Hospital, Room 400 July 9^th, 2024: 8:30am – 1:00pm

With a portfolio of approximately 135 clinical trials and 400 research studies, research is embedded into the fabric of Carilion Clinic. Today we honor the hundreds of patients at Carilion Clinic who participate in clinical trials, the committed professionals who work tirelessly to support the participants enrolled in clinical trials, and the physicians and healthcare providers leading clinical trials in our community, allowing access to cutting-edge therapies in our region!

If you come across any of these individuals today, share your appreciation!

To learn more about clinical trials at Carilion Clinic, please visit our Clinical Trials website.

Happy Clinical Trials Day!

Andrea Mohr, MHA, CCRP
Director, Clinical Trials
Carilion Clinic – Research and Development

Colleagues,

The end of Summer and commencement of Fall signals activities such as leaf raking, football, world series games, and crisp clear days to replace the smoldering heat and humidity of Summer. For many of you, Fall is your favorite time of the year. The theme of this month’s newsletter is people. You will read about individuals taking on expanded responsibilities through promotion and new hires starting their research career at Carilion Clinic. You will also meet two of our newest researchers to discuss their work and its impact on our patients and community.  Through our association with iTHRIV, you can listen to Virginia Tech Professor Margie Lee, DVM, MS, PhD discuss her personal journey to her present position at the VA-MD College of Veterinary Medicine. Lastly, I would like to welcome our new residents, fellows, and VTCSOM medical students as they start their chapter at Carilion Clinic.

Regards,

Francis X. Farrell, PhD
Senior Director, Research and Development

A Message from Dr. Robert Trestman

Over the last month, a group of us here at Carilion Clinic have been meeting to address barriers to successful research. We have begun to focus on a range of opportunities that we recognize are potential speed bumps or barriers to efficient research implementation. You will be hearing more about these efforts as our group addresses some of these challenges. These topics include, for example, challenges to data storage and sharing, expanding access to research participation, optimization of research protocols, and collaboration with those from other institutions. It's an exciting time here at Carilion as we work to vigorously expand our research portfolio and elevate both the number and scope of research studies conducted here in support of improving patient care and outcomes.

The Voices in Clinical and Translational Science Seminar Series is designed to lift underrepresented voices in research across the iTHRIV partnership.

Carilion Clinic TriNetX Virtual Training Schedule

Carilion offers instructor-led, focused training for an in-depth, step-by-step learning experience building patient cohorts and delving into Analytics. The facilitator will be Dee Myers. Please get in touch with HART@carilionclinic.org with the subject of 'TriNetX Training' for training outside of the scheduled sessions. If you haven’t taken a class or need a refresher, this is your opportunity to do so!  Let Dee Myers know which date you prefer and she will send a meeting invitation.

• Sept 7 from 10:30am – 12pm
• Sept 19 from 10:30am – 12pm
• Oct 12 from 10:30am – 12pm
• Oct 25 from 1:30 – 3pm
• Nov 15 from 10:30am – 12pm
• Dec 13 from 1:30 – 3pm

For more information visit: https://carilionclinic.org/health-analytics-research-team

New Employees
 

Leila Zavar, BS, Clinical Research Coordinator I – Research & Development

Leila is a new centralized R&D Clinical Research Coordinator on our team who will initially focus on supporting Surgery and Dermatology clinical trials. She is a new Virginia Tech graduate in Clinical Neuroscience, and comes to us with undergraduate research and clinical shadowing experience.

Sydnee Moses, BS, Clinical Research Coordinator II - Oncology

Sydnee Moses joined our Oncology research team at the beginning of August and will serve primarily in our Pediatric Oncology Department. Sydnee comes to us from Virginia Tech (VT), where she studied Human Nutrition, Foods, and Exercise as well as Psychology. Prior to joining our team, she worked as the Head Assistant Researcher at the Mukherjee Lab at VT, where she honed her skills conducting pre-clinical trials and managing a team of undergraduate research assistants. In her free time over the past 2 years, Sydnee has worked to develop a successful business of her own, and we are excited about the unique skillset she brings to our team.

Research Position Openings

Current opening in Research & Development:

Regulatory Affairs Specialist – Research and Development  (hybrid)

The Regulatory Affairs Specialist will support clinical trials at Carilion Clinic in a variety of therapeutic areas. Basic responsibilities include supporting research physician-investigators and clinical research coordinators with guidance on research policies and processes, IRB submissions, and regulatory document collection/maintenance. This position will work under the supervision of the Regulatory Affairs Manager within the Department of Research and Development. This position requires frequent communication with clinical research personnel, including investigators, research coordinators, IRB personnel, sponsors, clinical research organizations, and students throughout the study life cycle. Candidate must be able to work within time constraints, keep abreast of external regulatory requirements and changes, and manage multiple priorities.

My Project Path:

Resources and Processes for Research, Grants, and QA/QI

Want to do a project, but don’t know where to start? Or, experienced but want to see what new resources are available?

To learn about Carilion’s resources and processes for Research, Grants and QA/QI, visit https://redcap.link/MyProjectPath.  This tool provides easy navigation to topics of interest, including links to the Research and Development Application and the IRB PRIS3M application.

* Carilion Clinic Research and Development is honored to partner with a growing list of prestigious national and statewide research centers and healthcare organizations. Find out more about our collaborative research initiatives; explore our unique public-private partnerships with the Virginia Tech Carilion (VTC) School of Medicine, Virginia Tech, Fralin Biomedical Research Institute, Radford University Carilion, and others. Connect with our team to discuss opportunities to collaborate with our experts or become a participant.

iTHRIV Updates:

Upcoming Workshops and general information: https://portal.ithriv.org/#/home

Newsletter link: https://www.ithriv.org/april-2023-newsletter

Colleagues,

With the approach of Summer, many of you will find time to spend with family and friends on vacation, picnics, and outdoor activities. Throughout the summer, the Research and Development team will be interacting with the public to increase awareness of clinical research. To date, the team has participated in the Roanoke Pride Festival and Local Colors.  In addition, hopefully, you have seen our billboards and television commercial breaks highlighting that we have over 120 active clinical trials in progress. Clinical Research is not just an important part of the work we do at Carilion Clinic. Our commitment to research is, along with patient care and education, one of the three essential pillars supporting our mission to improve the health of the communities we serve. Please stop by if you see us at an upcoming festival or event and help us spread the word about the amazing work performed by our Health Care Providers bringing new and novel treatments to our patients.

Regards,

Francis X. Farrell, PhD
Senior Director, Research and Development

CTSA Seminar Today, Tuesday, June 6th at 2 p.m.!

The Voices in Clinical and Translational Science Seminar Series is designed to lift underrepresented voices in research across the iTHRIV partnership.

My Project Path:

Resources and Processes for Research, Grants, and QA/QI

Want to do a project, but don’t know where to start? Or, experienced but want to see what new resources are available?

To learn about Carilion’s resources and processes for Research, Grants and QA/QI, visit https://redcap.link/MyProjectPath.  This tool provides easy navigation to topics of interest, including links to the Research and Development Application and the IRB PRIS3M application.

Carilion Clinic TriNetX Virtual Training Schedule

Carilion offers instructor-led, focused training for an in-depth, step-by-step learning experience building patient cohorts and delving into Analytics. The facilitator will be Dee Myers. Please get in touch with HART@carilionclinic.org with the subject of 'TriNetX Training' for training outside of the scheduled sessions. If you haven’t taken a class or need a refresher, this is your opportunity to do so!  Let Dee Myers know which date you prefer and she will send a meeting invitation.

• Jun 7 from 10:30am – 12pm
• Jun 21 from 1:30 – 3pm
• July 11 from 10:30am – 12pm
• July 26 from 1:30 – 3pm

For more information visit: https://carilionclinic.org/health-analytics-research-team

New Employees
 

Angelica Flanders, BS, Clinical Research Coordinator II – Cardiothoracic Surgery 

Angelica is a new Clinical Research Coordinator on our team supporting Cardiothoracic Surgery.  She obtained her bachelor’s degree in Biological Sciences from the University of Rhode Island and, since then, Angelica has predominantly worked in product quality assurance as a Potential New Item Project Coordinator. In addition to project coordination, Angelica also has experience as a Microbiology Laboratory Technician.

Research Position Openings

Current opening in Research & Development:

Regulatory Affairs Specialist – Research and Development  (hybrid)

The Regulatory Affairs Specialist will support clinical trials at Carilion Clinic in a variety of therapeutic areas. Basic responsibilities include supporting research physician-investigators and clinical research coordinators with guidance on research policies and processes, IRB submissions, and regulatory document collection/maintenance. This position will work under the supervision of the Regulatory Affairs Manager within the Department of Research and Development. This position requires frequent communication with clinical research personnel, including investigators, research coordinators, IRB personnel, sponsors, clinical research organizations, and students throughout the study life cycle. Candidate must be able to work within time constraints, keep abreast of external regulatory requirements and changes, and manage multiple priorities.

iTHRIV Updates:

Upcoming Workshops and general information: https://portal.ithriv.org/#/home

Newsletter link: https://www.ithriv.org/april-2023-newsletter

Colleagues,

The arrival of Spring marks the emergence of temperate weather, pollination, and new growth. It also marks the winding down of the academic year including graduation and completion of research projects. To this end, Carilion Clinic Research Day celebrated the plethora of projects that our residents/ fellows and students completed with their respective Principal Investigator/ mentor. During the day, we learned about how our Department of Pharmacy is investigating new dosing paradigms to directly impact patient care. In addition, the new treatment options for depression and pain using low-intensity focused ultrasound and transcranial magnetic stimulation were discussed by our residents and VTCSOM medical students. Lastly, we also learned the important work conducted by Carilion Clinic and Radford University Carilion to detect COVID-19 in our wastewater in Roanoke and Salem VA sewersheds. As you browse the newsletter, I would like for you to read about our new Clinical Research Suite by Dr. Robert Trestman and the accomplishments of our faculty/ staff at the state, national and international levels.

Regards,
Francis X. Farrell, PhD
Senior Director, Research and Development

Memo from Dr. Robert Trestman, Institutional Research Officer

Carilion is rapidly progressing in our efforts to grow patient-centered research. As part of the process, we are pleased to announce the opening of the Riverside 4 Clinical Research Suite (RS4 CRS). This facility will serve as a multi-functional hub supporting clinical research activities. Research personnel will now have access to dedicated research space in the Riverside Complex, allowing for efficiencies in clinical trial coordination and participant experience. The suite will include Study Visit Rooms, a Specimen Processing Lab, and Hoteling Space for Research Personnel.

Study Visit Rooms: The RS4 Clinical Research Suite offers 3 study visit rooms, available by reservation, to accommodate research visits. The study visit rooms must be utilized for visits that can be completed by research personnel such as consent visits, survey and data collection visits, follow up study visits, and assessment visits that can be performed by certified clinical research staff (vital signs, ECGs). Future phases of development may allow for more advanced clinical procedures that require nursing or physician licensing. The RS4 suite is not staffed by clinical personnel during this phase. 

Specimen Processing Lab: In addition to study visit rooms, research personnel will have access to basic specimen processing equipment such as a centrifuge in the specimen processing lab. The specimen processing lab is limited to study teams who have active studies in the RS4 CRS.  

Hoteling Space for Research Personnel: The Clinical Research Suite has two workstations that may be used as hoteling space for research personnel. Study teams who do not have dedicated office space within the Riverside Complex may reserve workstations for use.  

We are delighted to share with you this next step in our development of Carilion’s research capacity. Details on the use of the RS4 Clinical Research Suite are listed below. Don’t hesitate to contact us at  Research@carilionclinic.org for more information or to arrange a visit.

Bob

Riverside 4 Clinical Research Suite Reservations and Fees 

Reservations 

1. A central calendar is set up via Microsoft Outlook, whereby investigators and study teams can reserve research rooms for study visits and workstations for hoteling 
2. The reservation process will be analogous to reserving conference rooms in Microsoft Outlook 
3. Reservations will be managed by R&D 

To make a reservation, contact Research@carilionclinic.org and include the following information: 

• Type of space needed (study visit room or workstation, specimen processing lab does not require reservations) 
• Date needed and duration needed, in hours 
•  Activity code for reservation billing 

 Fees 

1. Reservations will be reviewed for the previous month and related study activity codes will be charged at $50 per hour for exam rooms 
2. Reservations must be made at least 2 business days in advance and are first come, first serve. If it is your first reservation, please reserve at least 1 week in advance to allow for R&D to request badge access for you to enter the suite. 
3. No fee will be charged for hoteling space, but a reservation will be required 
4. Usage fee will apply for cancellations submitted with less than 24 hours’ notice 
5.  Study teams will be instructed to incorporate RS4 exam room fees into study budgets at the time of theinitial R&D application review, if applicable 

Promotions and New Employees
 

Jessica Nichols, B.S. - Clinical Research Coordinator IV

Please join me in congratulating Jessica Nichols for her promotion to the Clinical Research Coordinator IV position. Jessica began her research career in 2009 working as a CRC in Neurology. She transitioned into the Oncology research space in 2011, and worked as a CRC at Blue Ridge Cancer Care until she joined our team last year. Jessica has been ACRP certified since 2015, and she recently graduated from Radford University Carilion (RUC) in May of 2022 with a Bachelor of Science in Health Science. She is now pursuing the MSHS/ DHSc Dual Degree program at RUC. Jessica has been instrumental in the development of Carilion’s Oncology Research Program through her role as a preceptor for our newest Oncology CRCs. Congratulations, Jessica!

Nanci Dodson, BS, Clinical Research Coordinator I – Research & Development 

Nanci recently joined our team as a Research and Development Clinical Research Coordinator who will primarily support sponsored clinical trials in the surgery therapeutic area. Nanci had a prior career in the fitness industry and recently changed fields by pursuing a B.S. in Health Promotion, which she completed at the University of Lynchburg this past December. During her time there, Nanci was able to contribute to a handful of health promotion studies as a Research Assistant.

Bailey Steele, B.S. - Clinical Research Coordinator II - Oncology

Bailey Steele joined our team as a CRC II in Oncology last month. She will be working primarily in Surgical Oncology as we navigate opening new trials in that space. Bailey will be graduating in May with her Master of Public Health. She previously worked in qualitative data analysis at UVA Cancer Center Without Walls. She also has experience as a Public Health Ambassador at the New River Valley Regional Commission and as a Medical Assistant at Blue Ridge Pain Management. Bailey minored in horticulture at Virginia Tech and loves all things plants. She also has a blue pit bull, Oliver, who keeps her on her toes by wrestling with the neighborhood groundhogs.

Shannan Postell, M.S., Pharm.D. - Clinical Research Coordinator II - Oncology

Shannan Postell joined our team as a CRC II in Oncology last month. She will be supporting Pediatric Oncology as we work to expand outside of COG and into the industry sponsored space. Shannan earned her Doctor of Pharmacy and M.S. in Clinical Research from Campbell University in 2014 and has worked in retail pharmacy for over 15 years. She is now looking to make a chance and transition into clinical research. Shannan recently moved to Roanoke from Raleigh, NC, and she spends most of her free time with her one-year-old daughter and two Boston Terriers, Salt and Pepper. 

Rebecca (Becca) Butterworth, B.S. - Clinical Research Assistant

Becca supports Carilion Mental Health. She earned a Bachelor of Science degree from Virginia Tech in Human Nutrition, Foods, and Exercise. She came to R&D with a strong clinical background. Her work at Carilion Clinic providing direct patient care as a Clinical Associate provides valuable experience as she assumes research responsibilities.

Abigail Crawford, B.S. - Clinical Research Assistant

Abigail supports Carilion Mental Health. She earned a Bachelor of Science in Biochemistry from Bridgewater College. Her minor was in Psychology. At Bridgewater, she engaged in undergraduate bench research and worked as a Lab Assistant and Social Media Assistant.

Congratulations!

Congratulation to Jennifer Bath, DNP, RN, a Brain Injury Specialist, for presenting her research at the 14th World Congress on Brain Injury, in Dublin, Ireland. Jennifer presented her poster titled “Mortality associated with withdrawal of life-sustaining therapy for patients with severe traumatic brain injury: A retrospective single-center study.” 

Carilion Clinic TriNetX Virtual Training Schedule

Carilion offers instructor-led, focused training for an in-depth, step-by-step learning experience building patient cohorts and delving into Analytics. The facilitator will be Dee Myers. Please get in touch with HART@carilionclinic.org with the subject of 'TriNetX Training' for training outside of the scheduled sessions. If you haven’t taken a class or need a refresher, this is your opportunity to do so!  Let Dee Myers know which date you prefer and she will send a meeting invitation.

• Apr 19 from 1:30-3pm
• May 9 from 10:30am – 12pm
• May 25 from 1:30-3pm

For more information visit: https://carilionclinic.org/health-analytics-research-team

Research Position Openings

Current opening in Research & Development:

Clinical Research Coordinator (Cardiology)
https://jobs.carilionclinic.org/job/Roanoke-Clinical-Research-Coordinator-%28Cardiology%29-VA-24014/987389300/

iTHRIV Updates:

Upcoming Workshops and general information: https://portal.ithriv.org/#/home

Newsletter link: https://www.ithriv.org/news-letter

Colleagues,

I would like to remind everyone that the Research Day abstract submission due date is March 3^rd. To date, over fifty people have registered, and twenty-seven abstracts are under development. Analogous to last year, the rapid communication presentations will be in a virtual format allowing you to participate as time permits. The poster session will be in-person from 1:00-4:00 pm at CRMH, 6^th floor auditorium. Our intent is for all posters to be displayed during this time interval.  Please feel free to stop by and grab a coffee and snack while viewing posters with your colleagues. In this newsletter, you will find several upcoming virtual lectures from our association with iTHRIV and National COVID Cohort Collaboration (N3C). Lastly, we have feature articles from the Emergency Department and Health Analytics. We look forward to seeing you at Research Day on Tuesday, April 4^th, 2023. Details and registration/ abstract submission link is shown below.

Regards,

Francis X. Farrell, PhD
Senior Director, Research and Development

Memo from Dr. Robert Trestman, Institutional Research Officer

Culture is hard to change. And people are guided by personal experience more than external, dry evidence. This is true in many domains and is certainly true in medical care. Carilion Clinic is now well along a journey to transform our culture to one that expands upon our core values of collaboration, commitment, compassion, courage, and curiosity. By integrating research and health systems science into the fabric of clinical care we are working to improve the lives of our patients, their families, and our communities. We are doing this by growing the breadth and depth of impactful research. We are expanding our partnerships with faculty across Virginia Tech and through iTHRIVE as we support the growth of Carilion’s own research clinicians. We are working to recognize and reduce barriers to integrating research into clinical practice. We want our patients to have access to the very best of evidence-based care. We want our clinicians to know that, at the end of each workday, they are not only participating in providing great care but helping to shape the gold standard of tomorrow’s care. In this issue of our Research and Development Newsletter, you will see just some of these initiatives and can look forward to a growing list in the months ahead.

R&D Promotion

Congratulations to Danielle Mitchell, for her promotion to Clinical Research Manager for Oncology at Carilion Clinic. Danielle previously served as a clinical research coordinator for gynecologic oncology where she gained valuable experience in the field and distinguished herself as a leader. Danielle is a graduate of Liberty University with a Bachelor of Science in Biomedical Sciences and a minor in Accounting. Prior to her time at Carilion, she worked in the Emergency Department at Centra Health and worked with a biomedical device company in their device development division. In her new role, Danielle will oversee the oncology research staff and facilitate the expansion of the oncology research portfolio.

New Employees
 

Christopher Hinton, B.S. - Clinical Research Coordinator

Christopher Hinton joined our team as a CRC II in Gynecological Oncology in early December. He will serve as Danielle Mitchell’s replacement in the Gyn Onc space. Christopher has a B.S. in Biology and several years of experience in healthcare. He has a diverse scientific background, having worked as a clinical research coordinator, perfusion technician, environmental health specialist, field and lab scientist, and veterinary assistant. Christopher comes to us from Javara Research where he spent the last year working as a CRC. On a more personal note, Christopher enjoys traveling, outdoor activities, and spending time with friends and family.

Carilion Clinic TriNetX Virtual Training Schedule

Carilion offers instructor-led, focused training for an in-depth, step-by-step learning experience building patient cohorts and delving into Analytics. The facilitator will be Dee Myers. Please get in touch with HART@carilionclinic.org with the subject of 'TriNetX Training' for training outside of the scheduled sessions. If you haven’t taken a class or need a refresher, this is your opportunity to do so!  Let Dee Myers know which date you prefer and she will send a meeting invitation.

• Mar 7 from 10-11:30am
• Mar 23 from 1:30-3pm
• Apr 6 from 10:30am – 12pm
• Apr 19 from 1:30-3pm
• May 9 from 10:30am – 12pm
• May 25 from 1:30-3pm

For more information visit: https://carilionclinic.org/health-analytics-research-team

Congratulations Dr. Benjamin Coobs

Dr. Benjamin Coobs from the Department of Orthopaedics Surgery was awarded an AOSSM Snady Kirkley Clinical Outcome Research Grant for the study titled “Evaluating the efficacy of erector spinae block in routine hip arthroscopy.”

ACRP Virginia Chapter News

The ACRP Central Virginia Chapter is hosting Cara Spivey, Carilion's Clinical Research Coordinator for VTCSOM students, for her talk titled  “Medical Student Research: The Role of the Clinical Research Coordinator” on March 8th. Registration information to come.

Attention CRCs! 

Time & Effort Reporting Process Improvement

Due to the increased volume of time & effort reports being submitted to R&D, a centralized inbox has been established to streamline the processing of the reports.  From now on, monthly time & effort reports for staff working on sponsored projects should be emailed to EffortReports@CarilionClinic.onmicrosoft.com.  The email subject line as well as the file name should be <Lastname Month Year> (e.g., Hollen Feb 2023).  T&E reports are due by the last business day of each month. 

Please be sure to include the project activity code(s) on the form.  Research out to a member of the R&D team if you are unsure of the correct activity code(s). 

Research Position Openings

Current opening in Research & Development:

Clinical Research Coordinator (Cardiology)
https://jobs.carilionclinic.org/job/Roanoke-Clinical-Research-Coordinator-%28Cardiology%29-VA-24014/987389300/

iTHRIV Updates:

Upcoming Workshops and general information: https://portal.ithriv.org/#/home

Newsletter link: https://www.ithriv.org/news-letter

Colleagues,

It is already February 1^st of 2023 making this day 42 of Winter or better yet, 47 days until Spring. In our last quarter, sixteen investigators applied for funding to the Research Acceleration Program. This was the 18^th round of funding for pilot studies to support our research mission at Carilion Clinic. I would like to thank everyone that submitted a proposal and congratulate the seven research teams that were awarded funding. The funded projects range from reducing the number of undiagnosed and misdiagnosed traumatic brain injuries in older adults in a long-term care facility to exploring the ability to utilize bone tissue proximal to the site of Anterior Cervical Discectomy and Fusion (ACDF). Read about the projects and the principal investigators in this newsletter. 

Our annual Research Day will be held on Tuesday, April 4^th from 7:00 am-4:00 pm. The event will be a hybrid format with virtual presentations in the morning followed by an in-person poster session in the afternoon. See the details and registration link below. We look forward to your participation and abstracts. Lastly, please take a minute to read the memo from Dr. Robert Trestman, Institutional Research Officer.

Regards,

Francis X. Farrell, PhD

Senior Director, Research and Development

Memo from Dr. Robert Trestman

One of Carilion’s core values is Curiosity, a characteristic that is at the heart of research. It drives questions like: “How can we improve the health of our communities?” and “How do we improve the care we provide?” This core value is now coupled with Carilion’s Vision 2025, which includes a focus on patient-centered research- research that can make a meaningful difference in the lives of those in our care. 

This is happening at a time when Carilion is growing our academic ties to Virginia Tech and Radford University. It is happening at a time when our research partnership with the University of Virginia is maturing. It is also happening at a time when the budget of the National Institutes of Health has grown by $2.5 billion. 

Carilion has invested in building our research and development infrastructure over the past decade. We are now positioned to grow impactful research quickly across our enterprise. The year ahead promises to be a great one!

Fast Facts from the Human Research Protections Office (HRPO)

⇒HRPO is comprised of 3 distinct components: 

• Institutional Review Board (IRB)
• Education & Outreach
• Quality Assurance & Improvement Activities

⇒ Their mission is to protect the rights and welfare of Carilion research participants

Upcoming synchronous, virtual training sessions sponsored by the HRPO

• Thursday, February 9^th: Everything you’ve ever wanted to know about drafting your IRB application! 
• Thursday, March 16^th: The consent process 
• Thursday, April 18^th: Waivers of consent and HIPAA authorization 
• Thursday, May 11^th: QA/QI versus research 
• Thursday, June 8^th: Promptly reportable events 

All sessions will be held from 12:00 pm -1:00 pm via Teams. To sign up or for any research and ethics training needs, please get in touch with Trish Winter at pjwinter@carilionclinic.org.  She is available for 1:1 consultations or to schedule an individual or group training session.

Consent Templates Have Been Updated!

The main changes to the consent templates include the following items:

1. Video/audio recording & photography 
2. Future research contact  Clinicaltrials.gov
3. Legally Authorized Representative (LAR) Consent Process & Documentation

Please always access the latest IRB information on the IRB website:

https://www.carilionclinic.org/irb/forms#consent-templates

Congratulations!

Robin Dair was promoted to Financial Services Manager, Clinical Trials. Robin joined the Department of Research and Development six years ago after a successful career in corporate finance. During her time at Carilion Clinic, Robin has streamlined many of our financial reporting processes by working closely with Carilion Clinic Accounting/ Finance. In her new role, she will expand her responsibilities into other areas of our research portfolio. Leigh Gaylord, financial analyst, will report to Robin.

New Employees
 

Amy LB Frazier, DVM - Scientific Writer/Grants Facilitator

Amy started her position as a Scientific Writer/Grants Facilitator in December 2022. She is a certified Editor in the Life Sciences, earned a Bachelor of Science in general and molecular biology from Vanderbilt University, and received a Doctorate in Veterinary Medicine from the University of Tennessee. After a stint in private veterinary practice (birds, herps, and other pocket pets), she completed a postdoctoral fellowship in gene therapy at Fred Hutchinson Cancer Center and participated in research into various inflammatory diseases at a biotech start-up outside Seattle. Thereafter, Amy joined St Jude Children’s Research Hospital, first as a research associate in a virology laboratory focused on HIV/AIDS and then as a member of the Scientific Editing Department, where she collaborated with physicians and researchers from all over the globe. Altogether, Amy has been a medical and scientific editor and writer (either in-house or freelance) for almost 30 years. During non-work hours, Amy volunteers to raise and train puppies for careers as service dogs.

Carilion Clinic TriNetX Virtual Training Schedule

Carilion offers instructor-led, focused training for an in-depth, step-by-step learning experience building patient cohorts and delving into Analytics. The facilitator will be Dee Myers. Please get in touch with HART@carilionclinic.org with the subject of 'TriNetX Training' for training outside of the scheduled sessions. If you haven’t taken a class or need a refresher, this is your opportunity to do so!  Let Dee Myers know which date you prefer and she will send a meeting invitation.

• Feb 8 from 10-11:30am
• Feb 22 from 1:30-3pm
• Mar 7 from 10-11:30am
• Mar 23 from 1:30-3pm

Research Position Openings

Current opening in Research & Development:

Clinical Research Coordinator (Research and Development)
https://jobs.carilionclinic.org/job/Roanoke-Clinical-Research-Coordinator-Research-and-Development-VA-24013/958372900/ 

Clinical Research Coordinator (Cardiology)
https://jobs.carilionclinic.org/job/Roanoke-Clinical-Research-Coordinator-%28Cardiology%29-VA-24014/987389300/

Collaborative Undergraduate Biostatistics Experience 

The Collaborative Undergraduate Biostatistics Experience (CUBE) is an 8-week training program designed to give motivated, underrepresented undergraduate students in STEM the opportunity to engage in a full-time (~40 hours/week) collaborative data science experience, along with related professional development activities. CUBE is aimed at promoting diversity, equity, and inclusion in the STEM fields. 

The CUBE program is built on the following four pillars: 

1. 1) training in introductory biostatistics
2. 2) training in R programming
3. 3) professional development (PD)
4. 4) a collaborative research project addressing research questions in various disciplines.

This is being offered by Virginia Tech's Center for Biostatistics & Health Data Science. Applications are now being accepted. Click here for more information.

iTHRIV Updates:

Upcoming Workshops and general information: https://portal.ithriv.org/#/home

Newsletter link: https://www.ithriv.org/news-letter

Colleagues,

As we prepare for the end of 2022, I would like to reflect on some of the research highlights of fiscal year 2022. Carilion Clinic launched 21 new clinical trials bringing our total portfolio to 117. Our clinical trial revenue has trended upward year over year since 2016 with net positive margins to reinvest into our internal research endeavors. More importantly, 195 participants were enrolled in these trials exploring new therapies and devices to treat multiple diseases. In some cases, our Carilion Clinic physicians were the lead national Principal Investigator and/or the top enroller in the nation. This is a testament to the quality of healthcare and the expertise of our researchers. In addition to clinical trial research with industry partners, we continue to grow extramural funding of research by securing grants at the federal, state, and foundation level. Our internal research funding program, Research Acceleration Program, continues to grow in both the quality and number of submissions. In fiscal year 22, twenty-one applications (21) were submitted from 13 clinical sections with 10 receiving funding.  Other highlights include hiring additional clinical research coordinators to support our emerging Oncology research programs. Our laboratory at CRCH continues to grow in scope with utilization by VTCSOM medical students, Ph.D. candidates from Virginia Tech, undergraduates from Radford University Carilion, and Infectious Diseases physicians pursuing basic science research. In closing, wishing all a safe and joyous holiday season.

Francis X. Farrell, PhD

Senior Director, Research and Development

Congratulations!
 

Meredith Talmadge, RHIT, CIP has been appointed as the new Director of the Carilion Clinic Human Research Protections Office (HRPO) after a regional and national search. Meredith had previously served in her role for 15 years as the IRB Regulatory Affairs Administrator for full board reviews of investigator-initiated projects involving human subjects. Ms. Talmadge has prior experience with Health Information Management at Carilion Clinic, and as a research coordinator in Norfolk, VA. 

Interested in joining the HRPO? Here is an opportunity:  https://jobs.carilionclinic.org//job-invite/137588/

Carilion Clinic TriNetX Virtual Training Schedule

Carilion offers instructor-led, focused training for an in-depth, step-by-step learning experience building patient cohorts and delving into Analytics. The facilitator will be Dee Myers. Please get in touch with HART@carilionclinic.org with the subject of 'TriNetX Training' for training outside of the scheduled sessions. If you haven’t taken a class or need a refresher, this is your opportunity to do so!  Let Dee Myers know which date you prefer and she will send a meeting invitation.

• Dec 14 from 9:30 – 11:30am
• Jan 11 from 1:30-3pm
• Jan 25 from 10-11:30am
• Feb 8 from 10-11:30am
• Feb 22 from 1:30-3pm
• Mar 7 from 10-11:30am
• Mar 23 from 1:30-3pm

Research and Ethics Training

Trish Winter, Ph.D., Carilion's Human Subjects Research and Ethics Education Manager, is offering research and ethics training education upon request. Please contact her at pjwinter@carilionclinic.org for training or virtual office hours, held once a month.

Clinical Research Education Series

Introduction to LEAN
 

December 2, 2022 via Zoom (10-11am)

Pre-registration is required:
https://virginia.zoom.us/j/97947660591?pwd=NDFXOTN3UFBmVTdRUHE4SFYxNy9qQT09

Meeting ID: 979 4766 0591
Passcode: 975972
*This session will be recorded.

Course Description: This session will introduce clinical research (CR) professionals to LEAN methodology.  Attendees will review the evolution of LEAN processes and explore real world examples of how to assess, plan, and implement an improvement project.

Target Audience: Clinical Research professionals, Nurses, Physicians
Desired Outcomes: 
At the conclusion of this activity, participants should be able to:

• Review and describe how LEAN was developed.
• Describe LEAN terminology and methodology.
• Describe the steps in developing a LEAN project and review examples.

Provided by the University of Virginia School of Medicine and School of Nursing

Research Position Openings

Current opening in Research & Development:

Clinical Research Coordinator (Oncology)
https://jobs.carilionclinic.org/job/Roanoke-Clinical-Research-Coordinator-%28Oncology%29-VA-24016/935263900/ 

Clinical Research Coordinator (Research and Development)
https://jobs.carilionclinic.org/job/Roanoke-Clinical-Research-Coordinator-Research-and-Development-VA-24013/958372900/ 

Regulatory Affairs Specialist-Oncology (Hybrid Schedule Available)
https://jobs.carilionclinic.org/job/Roanoke-Regulatory-Affairs-Specialist-Oncology-%28Hybrid-Schedule-Available%29-VA-24011/931708000/

iTHRIV Updates:

Upcoming Workshops and general information: https://portal.ithriv.org/#/home

Newsletter link: https://www.ithriv.org/news-letter

New Employees
 

Clinical Research Assistants

Parker Chenault

Parker is a Clinical Research Assistant/Medical Scribe for Orthopaedics at ION who joined us in May. He attended the University of Virginia, earning a BA in Biology. While in Charlottesville, he earned EMT and Phlebotomy Technician certifications. He has served as a Senior Intern providing performance training, including the development of strength and conditional programs and conducting nutrition education. He has extensive observations of diagnostics, surgical procedures, and physical therapy.

Sam Reed

Sam joined R&D supporting Psychiatry and Behavioral Medicine in June. He earned a Bachelor of Science degree in Neuroscience from Christopher Newport University. There, he was active in leadership. His research, including as a Student Researcher and under a Research Apprenticeship, focused on hormones and behaviors. His continued experience as a Pharmacy Technician provides insight into the pharmaceutical business and customer service.

 Courtney Glover

Starting in September, Courtney joined the Emergency Medicine team. She received her BA in Foreign Affairs. She gained experience in healthcare working for a veterinary practice as a receptionist and assistant. Working for UVA Health, she gained experience in specimen processing and administrative functions. She has a strong history in customer relations and engagement with patients and families.

 Sydney Nelson

Sydney came to the Emergency Medicine team in September as a Blue Ridge Fellow. The Blue Ridge Fellows Program is a program designed for new college graduates with a focus on leadership development. She received her BS from the University of Florida in Psychology, Behavioral, and Cognitive Neuroscience and a BA in Spanish. There, she was able to conduct research involving language and cognitive development.

 Bridget Mason

Bridget earned a BS in Public Health from Shenandoah University. She is pursuing a Master of Public Health degree from George Washington University. She started with the Emergency Medicine team in October. She has research experience and continued interest in fall management, especially in the elderly. She brings to the team experience with caregiving, customer service, pharmacy operations, and liaising with medical insurance.

 Cameron Jones

Cameron started with us in November. He is supporting the Aortic Center. Cameron received a BS degree in Exercise Science from Old Dominion University where he engaged in a variety of undergraduate research opportunities. It was there he developed an interest in cardiovascular medicine. He has experience delivering direct patient care and has earned his Patient Care Technician Certification.

Colleagues,

Carilion Clinic is accepting applications to the Research Acceleration Program (RAP). The program is open to all Carilion Clinic employees seeking funds for clinical, biomedical, or behavioral research projects. While all innovative research proposals are welcomed, applicants are encouraged to pursue research in alignment with our Vision 2025 Research and Innovation Strategy.

A.    Expand, design, and invest in care delivery of the future.

B.    Grow and invest in clinical platforms that provide cutting edge-
treatment capabilities

C.    Deepen academic partnerships
• Virginia Tech
• Fralin Biomedical Research Institute at Virginia Tech Carilion.
• Radford University Carilion

This year the application process is a REDCap web form found at the Carilion Clinic Research and Development website: https://www.carilionclinic.org/research#research-acceleration-program. Those that have completed a research and development application in the past will find the new application familiar, including an online submission process and eSignature approval routing. The Project Narrative, Budget and other supporting documents are uploaded in the provided links in the application. In addition to the application, you will find instructions at a glance and updated and condensed guidelines. Applications are due by Monday, December 5^th 2022 at 5:00 pm. Good luck and I hope you consider applying.

Yet another funding opportunity for those pursuing health behavior research is a joint program between Carilion Clinic Research Acceleration Program, the Office of the Virginia Tech Vice President of Health Sciences and Technology, and the Center for Health Behaviors Research (CHBR). Proposals should align with the mission of Carilion Clinic—to improve the health of the communities we serve and seek to advance care through medical education and research—and with the mission and foci of the CHBR. The mission is to conduct and disseminate transformative health behaviors research with the primary objective of preventing and treating life-style related diseases. Funding will only be awarded to applications that are collaborations between Virginia Tech and Carilion Clinic. Complete instructions and further information are found in this newsletter. A Letter of Intent with supporting documents is due by Friday, December 2, 2022, to chbr@vtc.vt.edu.

Francis X. Farrell, PhD

Senior Director, Research and Development

Welcome to Carilion

Vice Chair of Research, Department of Surgery

Daniel B. Rukstalis, MD has joined Carilion Clinic as a urologic surgeon. He previously held the position of  Professor and Residency Program Director in Department of Urology at Wake Forest School of Medicine. In addition he was also employed by USC, Columbia.  He is a graduate of the University of Virginia and Eastern Virginia Medical School. Dr. Rukstalis has over 80 peer-reviewed publications in his specialty. He is the lead Principal Investigator for an international clinical trial for benign prostatic hypertrophy (BPH).

Carilion Clinic TriNetX Virtual Training Schedule

Carilion offers instructor led, focused training for an in-depth, step-by-step learning experience building patient cohorts and delving into Analytics. The facilitator will be Dee Myers. Please contact HART@carilionclinic.org with the subject of 'TriNetX Training' for training outside of the scheduled sessions. If you haven’t taken a class or need a refresher, this is your opportunity to do so.  Let Dee Myers know which date you prefer and she will send a meeting invitation.

• Oct 27 from 1:30 – 3:30pm
• Nov 17 from 1:30 – 3:30pm
• Dec 14 from 9:30 – 11:30am

iTHRIV Updates:

Upcoming Workshops and general information: https://portal.ithriv.org/#/home

Newsletter link: https://www.ithriv.org/news-letter

Colleagues,

As we embark on the Fall season, I would like to announce that Dr. Robert Trestman is the new Authorized Institutional Official for Research (Carilion Clinic). In this role he has the authority to speak for and legally commit the institution to compliance with the requirements of the federal regulations regarding the involvement of human subjects in research. This role was held previously by Dr. Daniel Harrington. The Department of Research and Development would like to thank Dr. Harrington for his strong leadership and dedication to research endeavors.

Over the past few years, our research operations have increased significantly in size and scope. In addition, we have developed strategic collaborations with our iTHRIV partners. In that regard, eight applications were submitted to the iTHRIV Pilot Translational and Clinical Studies Program.  One area that will be a focus this year is increased collaboration and alignment with Virginia Tech researchers. Over the next few months, we will explore areas for improvement. Please feel free to submit any ideas to research@carilionclinic.org.

Regards,

Francis X. Farrell, PhD

Senior Director, Research and Development

Carilion Clinic TriNetX Virtual Training Schedule

Carilion offers instructor led, focused training for an in-depth, step-by-step learning experience building patient cohorts and delving into Analytics. The facilitator will be Dee Myers. Please contact HART@carilionclinic.org with the subject of 'TriNetX Training' for training outside of the scheduled sessions. If you haven’t taken a class or need a refresher, this is your opportunity to do so.  Let Dee Myers know which date you prefer and she will send a meeting invitation.

• Sept 8 from 1:30 – 3:30pm
• Sept 21 from 9:30 – 11:30am
• Oct 12 from 9:30 – 11:30am
• Oct 27 from 1:30 – 3:30pm
• Nov 17 from 1:30 – 3:30pm
• Dec 14 from 9:30 – 11:30am

New Employees
 

Shelby Hamm, PhD - Clinical Research Coordinator II – Research & Development 

Shelby recently joined our team as a Research and Development Clinical Research Coordinator who will primarily support sponsored clinical trials in the rheumatology therapeutic area. Shelby earned both a bachelors and doctorate degree in Human Nutrition, Foods, and Exercise at Virginia Tech, focusing on Molecular and Cellular Science. She has experience as a research assistant in a basic science lab and as a teaching assistant for a course focused on methods for clinical evaluation of human health.

Britttny O'Toole, MS - Clinical Research Coordinator II - Cardiology

Please join us in welcoming Brittny O’Toole, our newest CRC team member.  She will be supporting our growing Cardiology research team. Brittny has her Master’s in Human Nutrition and Functional Medicine from the University of Western States, and brings with her an array of healthcare experiences as a scribe and nutrition coach.   Her leadership abilities and entrepreneurial spirit will be a value add to our team, and we look forward to working with her to grow and support Cardiology research.

Ahmed Al Qaffas, MS “E.” - Data Science Engineer Biostatistician - HART

E is a recent hire to the Health Analytics Research Team. He holds a Master's in Bioinformatics from Virginia Commonwealth University in Richmond, Virginia. His recent studies and work have focused on virology at the genomics level. 

Yili Zhong, PhD - Clinical Research Coordinator II – Aortic Center

Yili is a new Clinical Research Coordinator supporting clinical trials in the Aortic Center. She most recently earned a PhD in Pharmaceutical Sciences from Washington State University and has worked as a postdoctoral teaching fellow and postdoctoral scientist since then. While her experience has focused on basic science research, Yili had the opportunity to design and coordinate a clinical trial during her time as a PhD student.

iTHRIV Updates:

Upcoming Workshops and general information: https://portal.ithriv.org/#/home

Newsletter link: https://www.ithriv.org/news-letter

Colleagues,

Research and Development would like to welcome all incoming residents/ fellows and students to Carilion Clinic. Over the next few years, we hope that our department along with the Health Analytics Research Team and the Institutional Review Board can assist and support your research endeavors. To that end, one event that I would like to bring to your attention is the upcoming Research Education Series jointly created with the Office of Continuing Professional Development. The first session is on August 4^th, 2022 at 12 noon via Zoom. The topic is Research vs Quality Improvement/ Quality Assurance. Please visit the link https://www.carilionclinic.org/news/research-education-series to gain more information on this session and future sessions.  Also, the Pilot Translational and Clinic Studies and Community Organization and Research Institution Partnership grants through iTHRIV are due August 29^th, 2022. Please contact Vera Hollen, vlhollen@carilionclinic.org if you plan to submit a proposal. I hope you are enjoying your summer.

Regards,

Francis X. Farrell, PhD

Senior Director, Research and Development

Carilion Clinic TriNetX Virtual Training Schedule

Carilion offers instructor led, focused training for an in-depth, step-by-step learning experience building patient cohorts and delving into Analytics. The facilitator will be Dee Myers. Please contact HART@carilionclinic.org with the subject of 'TriNetX Training' for training outside of the scheduled sessions. If you haven’t taken a class or need a refresher, this is your opportunity to do so.  Let Dee Myers know which date you prefer and she will send a meeting invitation.

• Aug 25 from 1:30 – 3:30pm
• Sept 8 from 1:30 – 3:30pm
• Sept 22 from 9:30 – 11:30am
• Oct 12 from 9:30 – 11:30am
• Oct 27 from 1:30 – 3:30pm
• Nov 17 from 1:30 – 3:30pm
• Dec 14 from 9:30 – 11:30am

Utilize TriNetX Data to Publish

Publication Guidelines 

New Employees

Patricia (Trish) Winter, PhD, MT-BC – Human Subjects Research and Ethics Training Manager.

Trish is a board-certified music therapist with robust clinical experience, research experience, and IRB experience. She will be providing research and ethics education and training in support of the HRPO office. She is looking forward to working with you and your programs to obtain the most up-to-date information on research regulations and requirements for your unique research endeavors. For more information, or to schedule a training or individual meeting, you can contact Trish at pjwinter@carilionclinic.org or (540) 521-5890.

Departures

Carley Emerson’s last day at Carilion will be August 3. Carley has served in the role of Carilion’s Director of the HRPO and IRB for almost six years. Carley has enjoyed working with and learning from all of you. To assist with the transition, please include Meredith Talmadge and Brooke Blevins on all emails.

iTHRIV Updates:

Upcoming Workshops and general information: https://portal.ithriv.org/#/home

Newsletter link: https://www.ithriv.org/news-letter

Sponsored by Carilion Clinic

Patients may return to driving after having  their rotator cuff repaired, sooner than previously thought, according to new research from Dr. Peter Apel's lab in the Department of Orthopaedic Surgery. After sampling data from one pre-operative and four post-operative drives, the researchers determined that patients were able to utilize adaptive behaviors to allow for a safe driving techniques. This suggests that our rotator cuff repair patients may get back into the drivers seat sooner than expected.

"What we found was that patients made modifications to their driving techniques based on their shoulder being in a sling and they are still able to safely turn, break, merge and park," said Peter J. Apel, MD, PhD, the primary investigator on the study conducted at the Institute for Orthopaedics and Neurosciences.  

"As such, we have encouraged surgeons not to restrict patients from driving after their rotator cuff surgery as it turns out they are safe and they make themselves safe with adaptive behaviors," Dr. Apel said.

Back to Normal

Dr. Apel specializes in hand and upper extremity surgery, and is highly motivated to improve patient outcomes through research. He is especially interested in research that decreases the burden of healthcare on the patient and the system overall, such as these return to driving studies which he leads.

Dr. Apel and his lab have previously shown that a modeled-WALANT (wide-awake, local anesthetic, no tourniquet) state following carpal tunnel release (CTR) has no clinically relevant negative impact on post-operative driving, indicating similarly that CTR patients could drive home following a unilateral WALANT hand procedure.

Retooling Driving Recommendations

After successful publication of the WALANT study in The Journal of Bone & Joint Surgery, Dr. Apel and co-investigators decided to analyze how soon patients could safely return to driving after having a rotator cuff repair. As one of the most commonly performed orthopaedic procedures, Dr. Apel explains, it is common for patients to have been discouraged from driving for up to six weeks following the procedure.

"Those recommendations aren’t based in any science, and in an era like this where you need a car to do anything, those restrictions are incredibly burdensome," he said.

To assess for driving safety, instrumented vehicles from the Virginia Tech Transportation Institute were outfitted with special sensors and monitoring equipment to analyze enrolled patients two weeks before they underwent rotator cuff surgery,  and then at at weeks two, four, six and 12 following surgery. After analysis of both pre- and post-operative drives from all subjects, the investigators found no statistically significant differences in safety.

"This is the first time that a research study has ever looked at real patients driving and seen how these smart, adaptive patients make modifications to their techniques that make them safe to drive," Dr. Apel added.

To refer a patient to the Department of Orthopaedics at Carilion Clinic , contact 540-510-6200

 Learn More About Carilion Clinic’s Department of Orthopaedics

The Department of Orthopaedics at Carilion Clinic is the largest academic practice in Virginia with 50 board-certified physicians, 22 Advanced Care Practitioners and 26 Athletic Trainers. With fellowship trained surgeons in eight orthopaedic subspecialties, Carilion Clinic offers an evidence-based practice progressive in knowledge and skill. The department actively participates in the exchange of knowledge to advance the field of orthopaedic surgery through research and education.