The Clinical Research Coordinator (CRC) is responsible for the day-to-day management of clinical research studies conducted at the practice. This role ensures studies are performed in accordance with FDA regulations, ICH-GCP guidelines, sponsor protocols, and institutional policies while providing exceptional care to study participants.
The CRC serves as the primary liaison between sponsors, CROs, investigators, patients, and internal staff to ensure successful study execution from start-up through closeout.
Essential Responsibilities
Study Coordination
- Coordinate all aspects of assigned clinical research studies
- Review protocols and understand study-specific procedures
- Prepare for Site Initiation Visits (SIVs)
- Manage participant recruitment and enrollment
- Conduct informed consent process
- Schedule study visits
- Perform study-specific procedures within scope
- Collect study data accurately and timely
- Ensure protocol compliance
- Manage subject retention
Regulatory Compliance
- Maintain Investigator Site Files (ISFs)
- Maintain Regulatory Binders
- Ensure current medical licenses and certifications are maintained
- Prepare for sponsor audits
- Prepare for FDA inspections
- Ensure ICH-GCP compliance
- Maintain HIPAA compliance
- Report protocol deviations
- Report adverse events (AEs/SAEs)
- Maintain delegation logs
- Maintain training documentation
Data Management
- Enter data into Electronic Data Capture (EDC) systems
- Resolve sponsor data queries
- Maintain source documentation
- Ensure ALCOA+ documentation principles
- Complete visit documentation
- Review laboratory results
- Track study endpoints
Participant Care
- Educate patients regarding studies
- Obtain informed consent
- Coordinate study procedures
- Monitor participant safety
- Communicate with physicians regarding participant concerns
- Ensure excellent participant experience
Sponsor Communication
- Serve as primary contact for monitors
- Coordinate monitoring visits
- Respond to sponsor requests
- Prepare study documentation
- Participate in investigator meetings
Financial Responsibilities
- Track completed visits
- Verify billable procedures
- Assist with sponsor invoicing
- Track participant stipends
- Ensure accurate visit documentation for reimbursement
Qualifications
Required:
- 3+ years Clinical Research Coordinator experience
- Experience with Phase II-IV clinical trials preferred
- Knowledge of GCP, FDA regulations, and ICH Guidelines
- Experience using Electronic Data Capture systems
- Excellent organizational skills
- Strong communication skills
Preferred:
- CCRP or CCRC Certification
- Rheumatology experience
- Infusion experience
- IP injections/administration
- Phlebotomy experience
- Paper and digital source experience
- EMR experience (eClinicalWorks preferred)
Skills
- Excellent attention to detail
- Strong documentation skills
- Critical thinking
- Time management
- Multi-study coordination
- Patient education
- Professional communication
- Problem solving
Benefits:
- 401(k)
- Health insurance
- Paid time off
Work Location: In person
