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.
Anticipated Pay Range: 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 goesbeyond 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. Learn more at: https://hr.duke.edu/benefits/
