Ophthalmology Clinical Trials Regulatory Lead

Duke Careers; Durham (NC); On-site; USD 61,000 - 102,000; Full time

Job summary

Duke University’s Ophthalmology Clinical Research Unit (CRU) at the Duke Eye Center seeks a Regulatory Coordinator to support ophthalmology clinical trials, ensuring regulatory compliance and data integrity across studies.

You will coordinate regulatory submissions (IRB, IND, FDA forms), manage study documentation, train staff, and collaborate with investigators and sponsors to keep trials on schedule on-site in Durham.

Qualifications

• Minimum requirement of an Associate’s degree.
• Experience with regulatory submissions and clinical trials.
• Strong organizational and communication skills.

Responsibilities

• Coordinate regulatory submissions, documentation, and safety reporting across multiple studies.
• Prepare and maintain IRB, FDA, sponsor, and other regulatory submissions.
• Manage study-level regulatory documentation and compliance activities.
• Train and mentor staff on regulatory requirements and processes.

Skills

Regulatory submissions

IRB/FDA forms

Clinical research

Microsoft Office

Electronic medical records

OnCore/iRIS

Education

Associate’s degree

Tools

iRIS

OnCore

eREG Forte

Job description

Duke University’s Ophthalmology Clinical Research Unit (CRU) at the Duke Eye Center seeks a Regulatory Coordinator to support ophthalmology clinical trials, ensuring regulatory compliance and data integrity across studies.

You will coordinate regulatory submissions (IRB, IND, FDA forms), manage study documentation, train staff, and collaborate with investigators and sponsors to keep trials on schedule on-site in Durham.