Job Description
Position Summary
The Clinical Research Coordinator (CRC) is responsible for coordinating and managing clinical research studies in compliance with federal regulations, institutional policies, and Good Clinical Practice (GCP). The CRC works closely with the Principal Investigator (PI), sponsors, monitors, and study participants to ensure accurate data collection, subject safety, and protocol adherence.
Essential Duties and Responsibilities
Study Coordination
- Coordinate day-to-day operations of assigned clinical research studies
- Ensure study activities comply with study protocols, SOPs, ICH-GCP, FDA, and IRB requirements
- Serve as liaison between PI, sponsor, CRO, IRB, and study participants
- Prepare for and participate in sponsor monitoring visits, audits, and inspections
Participant Management
- Screen, recruit, and enroll study participants according to inclusion/exclusion criteria
- Conduct informed consent process and ensure proper documentation
- Schedule and conduct study visits per protocol
- Monitor participant safety and report adverse events and serious adverse events (SAEs)
Regulatory & Documentation
- Maintain regulatory binders (e.g., investigator files, essential documents)
- Prepare and submit IRB applications, amendments, continuing reviews, and reports
- Ensure timely reporting of protocol deviations, AEs/SAEs, and unanticipated problems
- Maintain accurate source documentation and case report forms (CRFs/eCRFs)
Data Management
- Collect, enter, and verify study data in EDC systems
- Resolve data queries and ensure data accuracy and completeness
- Maintain confidentiality and data integrity in accordance with HIPAA
Investigational Product (IP) Management
- Receive, store, dispense, and account for investigational products per protocol
- Maintain accurate drug/device accountability logs
- Coordinate with pharmacy or sponsor as needed
Quality & Compliance
- Follow SOPs and participate in quality improvement activities
- Assist with protocol training and site initiation activities
- Support internal and external audits and inspections
Qualifications
Required
- Bachelor’s degree in life sciences, health sciences,
- Knowledge of clinical research regulations and GCP
- Strong organizational, communication, and time-management skills
- Proficiency with Microsoft Office and EDC systems
- Ability to manage multiple studies simultaneously
Preferred
- 1–3 years of clinical research experience
- CRC certification (ACRP or SOCRA)
- Experience with IRB submissions and regulatory documentation
- Phlebotomy, ECG, or vital signs experience (if applicable)
Work Environment & Physical Requirements
- Clinical and office environment
- May require standing, walking, and lifting up to 25 lbs
- Occasional evening or weekend hours depending on study requirements