Lead Clinical Research Coordinator — Site Leader & Mentor

Elite Clinical Network; Denver (CO); On-site; USD 75,000 - 110,000; Full time

Job summary

Elite Clinical Network is seeking a Lead Clinical Research Coordinator to oversee day-to-day operations of multiple studies, provide site-level leadership, mentorship, and ensure protocol compliance, data integrity, and inspection readiness.

The role emphasizes coordinating start-up to close-out, IRB submissions, regulatory documentation, and ensuring study visits and data capture meet ICH-GCP standards while supporting sponsor communications.

Qualifications

• Bachelor’s degree in health sciences, life sciences, nursing, or related field.
• 3–4 years of clinical research experience with progression in scope and responsibility.
• Experience with IRB processes, REDCap/Medidata, and GCP compliance.
• Mentoring or leading coordinator-level staff preferred.

Responsibilities

• Coordinate and manage clinical research protocols from start-up to close-out.
• Recruit, screen, consent, and enroll eligible participants per protocol 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 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 procedures, risks, and responsibilities.
• Attend study training, SIVs, and investigator meetings as needed.

Skills

Attention to detail

Project management

Communication

HIPAA compliance

Education

Bachelor’s degree in health sciences, life sciences, nursing, or related field

CCRC certification or equivalent preferred

Tools

Microsoft Office Suite

Job description

Elite Clinical Network is seeking a Lead Clinical Research Coordinator to oversee day-to-day operations of multiple studies, provide site-level leadership, mentorship, and ensure protocol compliance, data integrity, and inspection readiness.

The role emphasizes coordinating start-up to close-out, IRB submissions, regulatory documentation, and ensuring study visits and data capture meet ICH-GCP standards while supporting sponsor communications.