R&D Clinical Research Coordinator and Regulatory Specialist
Clinical Research Coordinator and Regulatory Specialist Pool (CRC/RS Pool):
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:
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.