Senior Clinical Research Coordinator & Team Lead

ECN Operating LLC; Sun City (AZ); On-site; USD 70,000 - 90,000; Full time

Job summary

ECN Operating LLC is seeking a Lead Clinical Research Coordinator to oversee day-to-day operations of clinical studies, provide site leadership, and mentor the coordinator team.

In this role you will recruit and enroll participants, manage data and source documentation, and coordinate IRB submissions, while ensuring protocol compliance and data integrity across studies. You will serve as the primary contact for sponsors, CROs, and regulatory bodies, and support site readiness and audits.

Qualifications

• Bachelor’s degree in health sciences or related field required.
• CCRC certification preferred.
• 3–4 years clinical research experience with progression.
• Experience with IRB processes and GCP compliance.
• Mentoring/leadership experience preferred.
• Proficiency in MS Office and HIPAA compliance.

Responsibilities

• Coordinate and manage protocols from start-up to close-out.
• Recruit, screen, consent, and enroll participants per protocol.
• Collect, record, and maintain accurate data and source documentation.
• 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 data entry into EDC systems.
• Serve as primary contact for sponsors, CROs, monitors, and regulatory bodies.
• Maintain regulatory binders and study documentation per 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 participants regarding procedures, risks, responsibilities.
• Attend study training, SIVs, and investigator meetings as needed.
• Lead and mentor coordinator staff; oversee workload and timelines.
• Quality review of case report forms and source documentation.

Skills

Attention to detail

Organizational skills

Communication

Multitasking

HIPAA knowledge

Education

Bachelor’s degree

CCRC certification

Tools

REDCap

Medidata

Microsoft Office

Job description

ECN Operating LLC is seeking a Lead Clinical Research Coordinator to oversee day-to-day operations of clinical studies, provide site leadership, and mentor the coordinator team.

In this role you will recruit and enroll participants, manage data and source documentation, and coordinate IRB submissions, while ensuring protocol compliance and data integrity across studies. You will serve as the primary contact for sponsors, CROs, and regulatory bodies, and support site readiness and audits.