Regulatory Coordinator

Duke Careers•Durham, NC

22h•$61,026 - $101,959•Onsite

About The Position

The Ophthalmology Clinical Research Unit (CRU) within the Duke Eye Center is seeking a Regulatory Coordinator to join our team. In this role, you will play a critical part in supporting complex ophthalmology clinical trials, ensuring regulatory compliance. This position will also serve a key role to ensure data integrity, and patient safety across multiple studies. You will work at the intersection of regulatory operations, clinical data management, and safety reporting, supporting cutting-edge ophthalmology research. Your work will directly contribute to the advancement of innovative therapies while collaborating with multidisciplinary teams across Duke.

Requirements

Associate’s degree required
Minimum of two (2) 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
Ability to maintain required certifications and training for clinical research compliance
Adherence to institutional policies, SOPs, and federal regulations

Nice To Haves

Experience preparing clinical trial data for monitoring visits
Strong organizational skills with the ability to manage multiple complex studies simultaneously
Excellent written and verbal communication skills
Ability to quickly learn new clinical research systems (e.g., iRIS, OnCore, eREG Forte)
Experience with regulatory submissions (IRB, IND, FDA forms) and clinical trial compliance

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.