Lead Clinical Research Coordinator

ECN Operating•Chandler, AZ

11h•Onsite

About The Position

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.

Requirements

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

Nice To Haves

Certification as a Clinical Research Coordinator (CCRC) or equivalent preferred.
Prior experience mentoring, coaching, or leading coordinator-level staff strongly preferred.

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.
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.