Ophthalmology Trials Regulatory Coordinator

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

Job summary

Duke University Ophthalmology Clinical Research Unit (CRU) within the Duke Eye Center is seeking a Regulatory Coordinator to support complex ophthalmology trials, ensuring regulatory compliance and data integrity across studies.

You will coordinate submissions (IRB, IND, FDA forms), maintain regulatory documents, and mentor staff on processes, working onsite with Duke investigators and sponsors to advance vision-related therapies.

Qualifications

• Associate’s degree required.
• Minimum of two years of research or regulatory experience.
• Completion of the DOCR North Carolina state-approved Clinical Research Apprenticeship may substitute for one year of experience.
• 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 coordination

Regulatory compliance

Communication

Organization

Regulatory submissions

Education

Associate degree

Tools

MS Office

Electronic medical records (EMR)

Job description

Duke University Ophthalmology Clinical Research Unit (CRU) within the Duke Eye Center is seeking a Regulatory Coordinator to support complex ophthalmology trials, ensuring regulatory compliance and data integrity across studies.

You will coordinate submissions (IRB, IND, FDA forms), maintain regulatory documents, and mentor staff on processes, working onsite with Duke investigators and sponsors to advance vision-related therapies.