Ophthalmology Regulatory Affairs Specialist

Duke PA; Durham, Northern (NC, KY); Hybrid; USD 61,000 - 102,000; Full time

Job summary

The Ophthalmology Clinical Research Unit (CRU) at the Duke Eye Center seeks a Regulatory Coordinator to support complex ophthalmology clinical trials and ensure regulatory compliance. You will contribute to data integrity and patient safety across multiple studies.

Responsibilities include coordinating regulatory submissions (IRB, IND, FDA forms), maintaining study documents, and collaborating with investigators and sponsors.

Qualifications

• Associate’s degree required.
• Minimum of two years of research or regulatory experience.
• Experience with regulatory submissions (IRB, IND, FDA forms) and clinical trial compliance preferred.
• Proficiency in Microsoft Office and web-based applications including electronic medical records.

Responsibilities

• Coordinate regulatory submissions, documentation, and safety reporting activities across multiple clinical research studies in compliance with applicable regulations, institutional policies, SOPs, and study protocols.
• Prepare and maintain IRB, FDA, sponsor, and other regulatory submissions and documentation, including addressing regulatory questions and issues in collaboration with investigators and study teams.
• Manage study-level regulatory documentation and compliance activities, including preparation for monitoring visits, audits, study closeout, and document storage.
• Coordinate site visits and communicate effectively with sponsors, CROs, investigators, and other research stakeholders to support successful study execution and compliance.
• Train and mentor research staff on regulatory requirements, institutional processes, and clinical research compliance, while providing oversight of junior staff as appropriate.

Skills

Regulatory compliance

IRB submissions

FDA submissions

Clinical research

Microsoft Office

Electronic medical records

Communication skills

Education

Associate’s degree

Tools

iRIS

OnCore

eREG Forte

Job description

The Ophthalmology Clinical Research Unit (CRU) at the Duke Eye Center seeks a Regulatory Coordinator to support complex ophthalmology clinical trials and ensure regulatory compliance. You will contribute to data integrity and patient safety across multiple studies.

Responsibilities include coordinating regulatory submissions (IRB, IND, FDA forms), maintaining study documents, and collaborating with investigators and sponsors.