Lead Clinical Research Coordinator

ECN Clinical; Florida; Vor Ort; USD 90.000 - 125.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Attention to detail

Organizational skills

Project management

Communication skills

Microsoft Office

HIPAA compliance

Ausbildung

Bachelor's degree in health sciences or related field

CCRC certification preferred

Tools

REDCap

Medidata

Jobbeschreibung

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:

ECN Clinical 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.