Position Summary:
The Lead Clinical Research Coordinator (Lead CRC) is responsible for managing and coordinating the day-to-day operations of clinical research studies, while also providing site-level leadership, mentorship, and oversight to the coordinator team. Reporting to the
Site Manager, the Lead CRC ensures protocol compliance, data integrity, and inspection readiness, and serves as the primary resource and first point of escalation for the coordinator group.
Key Responsibilities:
- Coordinate and manage clinical research protocols from start-up to close-out.
- Recruit, screen, consent, and enroll eligible participants in compliance with study protocols and ethical guidelines.
- Collect, record, and maintain accurate data and source documentation for each study subject.
- Schedule and conduct study visits and procedures per protocol and ICH-GCP standards.
- Prepare and submit IRB submissions, amendments, continuing reviews, and adverse event reports.
- Ensure timely and accurate data entry into electronic data capture (EDC) systems.
- Serve as the primary point of contact for sponsors, CROs, monitors, and regulatory bodies.
- Maintain and organize regulatory binders and study documentation in compliance with FDA and GCP requirements.
- Monitor study inventory and order supplies as needed.
- Support audit readiness and participate in monitoring visits, audits, and inspections.
- Educate and communicate with study participants regarding study procedures, risks, and responsibilities.
- Attend study training, site initiation visits (SIVs), and investigator meetings as needed.
Leadership Responsibilities:
- Serve as the primary site-level resource and mentor for clinical research coordinators, including onboarding and ongoing training of new staff.
- Oversee distribution of study assignments and monitor team workload, visit coverage, and protocol timelines across coordinators.
- Conduct quality review of case report forms and source documentation completed by other coordinators to support data integrity and inspection readiness.
- Serve as the first point of escalation for protocol questions, monitor findings, and routine sponsor and IRB communications, escalating to the Site Manager as needed.
- Support the Site Manager with operational coordination, scheduling, and site readiness, and provide coverage in the Site Manager's absence where appropriate.
- Maintain site-level training documentation and support team-wide GCP and regulatory compliance.
Qualifications:
Education:
- Bachelor’s degree in health sciences, life sciences, nursing, or related field required.
- Certification as a Clinical Research Coordinator (CCRC) or equivalent preferred.
Experience:
- Minimum 3-4 years of experience in clinical research, preferably in a coordinator role, with demonstrated progression in scope and responsibility.
- Experience with IRB processes, electronic data capture (e.g., REDCap, Medidata), and GCP compliance.
- Prior experience mentoring, coaching, or leading coordinator-level staff strongly preferred.
Skills:
- Strong attention to detail and organizational skills.
- Ability to manage multiple projects and meet deadlines.
- Excellent communication and interpersonal skills.
- Proficiency in Microsoft Office Suite (Word, Excel, Outlook).
- Familiarity with HIPAA and human subject protection regulations.
Working Conditions:
- May involve direct patient interaction, phlebotomy, specimen processing, and travel between sites.
- Must be able to work occasional evenings or weekends depending on study requirements.
Physical Requirements:
- Ability to stand, walk, sit, use hands, and reach with arms.
- Ability to lift up to 25 pounds occasionally.
Equal Opportunity Employer:
Elite Clinical Network is an equal opportunity employer and does not discriminate on the basis of race, color, religion, gender, gender identity, sexual orientation, national origin, disability, age, or veteran status.
