Lead Clinical Research Coordinator — Site Leader & Mentor

ECN Operating LLC; Denver (CO); On-site; USD 90,000 - 130,000; Full time

Job summary

ECN Operating LLC is seeking a Lead Clinical Research Coordinator to oversee day-to-day study operations, ensure protocol compliance, and mentor the coordinator team. You will manage start-up through close-out, maintain data integrity, and coordinate with sponsors and IRBs.

Qualifications include a Bachelor’s degree in health or life sciences, 3–4 years in clinical research, experience with IRB, REDCap and Medidata, and leadership ability to train staff and support audit readiness.

Qualifications

• Minimum 3–4 years of experience in clinical research with progression.
• Experience with IRB processes, REDCap, Medidata, and GCP.
• Experience mentoring, coaching, or leading coordinator staff preferred.

Responsibilities

• Coordinate and manage protocols from start-up to close-out.
• Recruit, screen, consent, and enroll participants per protocol.
• Maintain accurate data and source documentation.
• Schedule visits and procedures per protocol and ICH-GCP.
• Prepare IRB submissions and adverse event reports.
• Ensure timely data entry into EDC systems.
• Serve as primary contact for sponsors, CROs, and regulators.
• Maintain regulatory binders and study docs per FDA/GCP.
• Monitor study inventory and supplies; support audits.

Skills

Attention to detail

Multitasking

Communication

MS Office

HIPAA familiarity

Education

Bachelor’s degree in health/life sciences or related field

CCRC certification (preferred)

Tools

REDCap

Medidata

Job description

ECN Operating LLC is seeking a Lead Clinical Research Coordinator to oversee day-to-day study operations, ensure protocol compliance, and mentor the coordinator team. You will manage start-up through close-out, maintain data integrity, and coordinate with sponsors and IRBs.

Qualifications include a Bachelor’s degree in health or life sciences, 3–4 years in clinical research, experience with IRB, REDCap and Medidata, and leadership ability to train staff and support audit readiness.