Regulatory Coordinator

Be You.

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.

Minimum 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

Preferred Qualifications:

• 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

Other Requirements:

• Ability to maintain required certifications and training for clinical research compliance
• Adherence to institutional policies, SOPs, and federal regulations

This position is:

• Onsite. The work is performed on-site or at a designated assignment location.

Be Bold.

• 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.

Choose Duke.

At Duke, you'll join a nationally recognized academic medical center and research enterprise dedicated to transforming health through discovery, innovation, and collaboration. You'll work alongside world-class clinicians, researchers, and educators while helping advance treatments and improve the lives of patients affected by vision-related conditions.

Duke offers:

• A collaborative and inclusive work environment.
• Opportunities for professional growth and career development.
• Access to cutting-edge research and innovative technologies.
• Comprehensive benefits and wellness programs.
• The opportunity to make a meaningful impact on patient care and scientific advancement.