Lead Clinical Research Coordinator

ECN Operating LLC; Denver (CO); Sur place; USD 90 000 - 130 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Attention to detail

Multitasking

Communication

MS Office

HIPAA familiarity

Formation

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

CCRC certification (preferred)

Outils

REDCap

Medidata

Description du poste

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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.