Regulatory Coordinator, Clinical Trials & IRB Submissions

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 seeks a Clinical Research Regulatory Coordinator-CEDAS to manage regulatory activities for complex clinical protocols in GI biology and disease. You will prepare IRB submissions, maintain regulatory files, and conduct quality assurance tasks.

Proficiency with Veeva SiteVault and Florence, plus MS Outlook/Word/Excel, is required. A Bachelor's degree or equivalent is necessary, and clinical trials experience is preferred.

Qualifications

• Bachelor’s degree or equivalent combination of education and experience.
• Experience coordinating clinical trials preferred.
• Prepare IRB submissions and maintain regulatory files.
• Use eRegulatory systems such as Veeva SiteVault and Florence.
• Proficiency in Microsoft Outlook, Word, and Excel.

Responsibilities

• Manage regulatory documentation and coordinate Institutional Review Board submissions for clinical research.
• Analyze and reconcile regulatory information from multiple sources.
• Create, gather, edit, compile, and report regulatory information for research protocols.
• Maintain regulatory files and assist with quality assurance activities.
• Support regulatory processes and ensure compliance across studies.

Skills

Regulatory coordination

Quality assurance

Documentation management

Education

Bachelor’s degree

Tools

Veeva SiteVault

Florence

Microsoft Outlook

Microsoft Word

Microsoft Excel

Job description

The University of North Carolina at Chapel Hill seeks a Clinical Research Regulatory Coordinator-CEDAS to manage regulatory activities for complex clinical protocols in GI biology and disease. You will prepare IRB submissions, maintain regulatory files, and conduct quality assurance tasks.

Proficiency with Veeva SiteVault and Florence, plus MS Outlook/Word/Excel, is required. A Bachelor's degree or equivalent is necessary, and clinical trials experience is preferred.