Clinical Research Regulatory Coordinator - Advanced

The University of North Carolina at Chapel Hill; Chapel Hill (NC); On-site; USD 48,000 - 66,000; Full time

Job summary

The University of North Carolina at Chapel Hill is seeking a Clinical Research Regulatory Coordinator-CEDAS to manage regulatory activities for diverse GI/GD research protocols. You will prepare and submit IRB documents, maintain regulatory files and ensure QA across trials.

Ideal candidates hold a Bachelor’s degree and have demonstrated experience with eRegulatory tools (Veeva SiteVault, Florence) and clinical trial coordination in academic settings. Strong organizational skills are a must.

Qualifications

• Bachelor’s degree or equivalent in a related field.
• Preferred experience coordinating clinical trials with regulatory systems.
• Experience with eRegulatory platforms (Veeva SiteVault, Florence).

Responsibilities

• Lead regulatory management for complex clinical protocols.
• Create, gather, edit, compile and report regulatory information.
• Coordinate IRB submissions and applications management.
• Maintain regulatory files and perform QA activities.

Skills

Clinical trials coordination

Regulatory management

eRegulatory systems

IRB submissions

Education

Bachelor’s degree

Tools

Veeva SiteVault

Florence

Job description

The University of North Carolina at Chapel Hill is seeking a Clinical Research Regulatory Coordinator-CEDAS to manage regulatory activities for diverse GI/GD research protocols. You will prepare and submit IRB documents, maintain regulatory files and ensure QA across trials.

Ideal candidates hold a Bachelor’s degree and have demonstrated experience with eRegulatory tools (Veeva SiteVault, Florence) and clinical trial coordination in academic settings. Strong organizational skills are a must.