Position Summary
The Senior Clinical Research Coordinator is responsible for the overall management of assigned clinical trials, including both operational and administrative functions such as regulatory compliance. This role requires clear and consistent communication with study sponsors, monitors, CROs, the Principal Investigator (PI), and the Site Manager. Strict adherence to site SOPs is required.
The Senior CRC oversees daily study operations, ensures protocol compliance, and represents the site in a professional, ethical, and positive manner at all times.
- Key responsibilities
- Manage day-to-day operations of assigned clinical trials
- Communicate study information clearly to investigators, sponsors, and study participants/caregivers
- Train study team members and monitor study activities to ensure compliance with protocols and applicable regulatory requirements (local, state, federal, and institutional)
- Ensure source documentation is completed accurately and contemporaneously during participant visits
- Enter source data into EDC systems within 48 hours of participant visits
- Maintain inventory of lab and study supplies; order supplies or delegate ordering to Research Assistant as needed
- Attend investigator meetings with the Principal Investigator, ask relevant questions, and gather key study information
- Participate in site initiation visits and conduct site tours as required
- Coordinate with recruitment/business teams to support effective study enrollment strategies
- Maintain accurate study records including case report forms, drug accountability logs, and related documentation
- Communicate with laboratories and investigators regarding lab results and findings
- Order investigational drugs or devices required for study completion
- Oversee specimen handling, including requisition, collection, labeling, storage, and shipment
- Perform protocol-specific procedures (e.g., participant interviews, vital signs, ECGs, and specimen collection)
- Record adverse events and side effects and collaborate with investigators on sponsor reporting requirements
- Coordinate sponsor monitoring visits and maintain ongoing sponsor communication
- Resolve EDC queries within 24 hours of issuance
- Manage investigational product accountability, including receipt, storage, dispensing, reconciliation, and reporting of discrepancies
- Maintain master study logs (ICF, patient ID, enrollment, etc.)
- Support preparation for and participation in quality assurance audits
- Ensure proper drug storage, labeling, and immediate placement into secure storage upon receipt
- Maintain accurate daily temperature logs as required
- Prepare source documents in advance of participant visits
- Maintain up-to-date training, delegation, and study logs
- Ensure timely completion and PI review of all safety reports
- Serve as a subject matter expert in clinical research, providing guidance and support to peers
- Perform other duties as assigned
- Required skills & abilities
- Experience leading 6–8 clinical studies preferred
- Experience training and mentoring junior coordinators
- Strong ability to work independently and collaboratively within a team
- CCRC or CCRP certification preferred
- Education & experience
- High school diploma or GED required (some college preferred)
- 3–5+ years of clinical research experience required
- Physical requirements
- Must be able to work onsite during standard business hours
- Must be able to lift up to 15 pounds occasionally
