Regulatory Coordinator

Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System comprise Duke Health, a world-class academic medical center.

About the role

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

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

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.

Benefits

• 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

Pay

Duke University provides an annual base salary range for this position as USD $61,026.00 to USD $101,959.00. Duke University considers factors such as (but not limited to) scope and responsibilities of the position; candidate's work experience, education/training, and key skills; internal peer equity; as well as market and organizational considerations when extending an offer. Your total compensation goes beyond the dollars on your paycheck. Duke provides comprehensive and competitive medical and dental care programs, generous retirement benefits, and a wide array of family-friendly and cultural programs to eligible team members.

Schedule

This position is onsite. The work is performed on-site or at a designated assignment location.