Lead Clinical Research Coordinator — Site Leader & Mentor

ECN Clinical; Florida; On-site; USD 90,000 - 125,000; Full time

Job summary

ECN Clinical is seeking a Lead Clinical Research Coordinator to manage day-to-day study operations and provide site-level leadership to the coordinator team. You will ensure protocol compliance, data integrity, and inspection readiness while serving as the primary resource for the group.

You will mentor coordinators, oversee study timelines, and coordinate with sponsors, CROs, and regulatory bodies. A strong background in GCP, IRB processes, and EDC systems is essential for success.

Qualifications

• Bachelor's degree required in health sciences or related field.
• CCRC certification preferred.
• Experience with IRB processes, EDC systems, and GCP compliance.
• Prior mentorship or leadership of coordinator-level staff is a plus.

Responsibilities

• Coordinate and manage clinical research protocols from start-up to close-out.
• Recruit, screen, consent, and enroll participants per protocol and ethics guidelines.
• Collect, record, and maintain data and source documentation for each subject.
• Schedule and conduct study visits per protocol and ICH-GCP standards.
• Prepare and submit IRB submissions, amendments, continuing reviews, and AE reports.
• Ensure timely data entry into electronic data capture (EDC) systems.
• Serve as primary contact for sponsors, CROs, monitors, and regulators.
• Maintain regulatory binders and study documents per FDA and GCP.
• Monitor study inventory and order supplies as needed.
• Support audit readiness and participate in audits and inspections.
• Educate participants about procedures, risks, and responsibilities.
• Attend training, SIVs, and investigator meetings as required.
• Lead and mentor coordinators; oversee workload and timelines.

Skills

Attention to detail

Organizational skills

Project management

Communication skills

Microsoft Office

HIPAA compliance

Education

Bachelor's degree in health sciences or related field

CCRC certification preferred

Tools

REDCap

Medidata

Job description

ECN Clinical is seeking a Lead Clinical Research Coordinator to manage day-to-day study operations and provide site-level leadership to the coordinator team. You will ensure protocol compliance, data integrity, and inspection readiness while serving as the primary resource for the group.

You will mentor coordinators, oversee study timelines, and coordinate with sponsors, CROs, and regulatory bodies. A strong background in GCP, IRB processes, and EDC systems is essential for success.