Clinical Research Lead & Study Operations Mentor

ECN Operating LLC; Chandler (AZ); On-site; USD 85,000 - 110,000; Full time

Job summary

ECN Operating LLC in Chandler, AZ seeks a Lead Clinical Research Coordinator to oversee day-to-day study operations and mentor the coordinator team.

You will ensure protocol compliance, data integrity, and inspection readiness, coordinating from start-up to close-out and serving as primary contact for sponsors.

This role requires 3–4 years in clinical research, IRB and EDC experience, and strong leadership and communication skills.

Qualifications

• Bachelor’s degree in health sciences or related field required.
• CCRC certification or equivalent preferred.
• 3–4 years in clinical research with progression.
• Experience with IRB processes, REDCap/Medidata, and GCP.

Responsibilities

• Coordinate and manage protocols from start-up to close-out.
• Recruit, screen, consent, and enroll participants per protocol.
• Record data and maintain source documents accurately.
• Schedule visits and procedures per protocol and ICH-GCP.
• Prepare IRB submissions, amendments, continuing reviews, and AE reports.
• Ensure timely data entry into EDC systems.
• Serve as primary contact for sponsors, CROs, and regulators.
• Maintain regulatory binders and study documentation per FDA/GCP.
• Monitor study inventory and order supplies as needed.
• Support audits, monitoring visits, and inspections.
• Educate participants about procedures, risks, and responsibilities.
• Attend training, SIVs, and investigator meetings.

Skills

Attention to detail

Organizational skills

Multi-project management

Communication

Microsoft Office

HIPAA compliance

Education

Bachelor’s degree in health sciences or related field

CCRC certification preferred

Tools

REDCap

Medidata

Job description

ECN Operating LLC in Chandler, AZ seeks a Lead Clinical Research Coordinator to oversee day-to-day study operations and mentor the coordinator team.

You will ensure protocol compliance, data integrity, and inspection readiness, coordinating from start-up to close-out and serving as primary contact for sponsors.

This role requires 3–4 years in clinical research, IRB and EDC experience, and strong leadership and communication skills.