Position Overview:
The Clinical Research Coordinator III is responsible for managing all aspects of assigned clinical trials, ensuring regulatory compliance and effective communication among stakeholders, including investigators, sponsors, study monitors, CROs, and site management. The CRC III plays a critical role in study operations, participant care, and adherence to protocols while upholding professional, ethical, and organizational standards.
Key Responsibilities:
Study Management & Documentation
- Oversee daily trial operations and ensure timely, accurate completion of source documentation and data entry (within 48 hours of visits).
- Maintain study records, including case report forms, drug accountability logs, and master logs (e.g., ICF, patient ID, enrollment).
- Resolve EDC queries within 24 hours and prepare for quality assurance audits.
Participant Interaction
- Inform participants and caregivers about study procedures and expected outcomes.
- Conduct protocol-specific tasks such as interviews, vital signs, ECGs, and lab specimen collection.
- Dispense drugs/devices, calculate dosages, and provide instructions for compliance.
Compliance & Training
- Ensure adherence to site SOPs and local, federal, and institutional regulations.
- Train study team members and monitor compliance with study protocols.
- Maintain and update training logs, delegation logs, and safety reports for all studies.
Coordination & Communication
- Schedule and attend investigator meetings, site initiation visits, and monitoring visits.
- Collaborate with business and recruitment teams to optimize participant enrollment.
- Act as a liaison between the study site, sponsor, and laboratories regarding study progress and findings.
Supplies & Inventory Management
- Manage inventory of lab and study supplies; ensure timely ordering or delegate tasks as needed.
- Organize and maintain drug storage, ensuring accurate temperature logs and immediate logging of shipments.
Additional Responsibilities
- Record and report adverse events to investigators and sponsors.
- Provide subject matter expertise to support and guide peers.
- Perform other duties as assigned to ensure study success.
This role requires exceptional organizational skills, proactive problem-solving, and the ability to represent the site professionally to all stakeholders. The CRC III is instrumental in ensuring high-quality clinical research that complies with regulatory standards.
Schedule : Monday - Friday 7am-4pm or 8am-5pm, flexibility needed with patients
Education and Experience:
- GED or HS Diploma required (Some College preferred)
- Minimum of 3+ years clinical research experience required
- Endocrinology experience is preferred