Regulatory Coordinator, Senior - Duke Cancer Institute
About The Position
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. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.Be You. The Duke Cancer Institute (DCI) Adult Bone Marrow Transplant, Hematologic Malignancies & Cellular Therapy Clinical Research Program (BMT) is looking for a Regulatory & Safety Operations Manager to lead day‑to‑day regulatory and safety operations across a complex portfolio of oncology clinical trials and research studies. You’ll be the go‑to expert for IND submissions, FDA interactions, and institutional policies—guiding multiple study teams through startup, maintenance, audits, and closeout in partnership with the Oncology Clinical Research Unit (CRU). In this role, you will: Mentor and manage a high‑performing regulatory team, shaping processes and SOPs that keep studies inspection‑ready. Serve as a senior resource to PIs and study staff on U.S. and international regulatory compliance, safety reporting, and document control. Coordinate sponsor/CRO communications and site visits, translate scientific proposals into protocol elements for complex investigator‑initiated studies, and ensure institutional and federal compliance across the portfolio. If you’re energized by building scalable processes, coaching talent, and ensuring the highest standards of patient safety and regulatory integrity, this is a chance to make a visible impact on innovative cancer research at Duke.
Requirements
- Education/Training: Associate’s degree required.
- Experience: Minimum 6 years of research or regulatory experience. Completion of the DOCR North Carolina state‑approved Clinical Research Apprenticeship may substitute for 1 year of required experience. A Bachelor’s degree may substitute for 2 years of required experience.
- Skills: Proficient with computing software and web‑based applications (e.g., Microsoft Office and electronic medical record). Strong interpersonal and communication skills to get work done effectively.
- Ability to navigate complex stakeholder environments (PIs, sponsors/CROs, DSMBs, IRBs, institutional offices).
- Availability for occasional early/late meetings aligned to sponsor timelines and global collaborators; periodic support for audits/inspections.
- Compliance with all Duke and protocol‑specific training/certifications; maintain currency on SOPs, regulations, and protocol requirements.
Nice To Haves
- Oncology and/or clinical research experience, education, or training.
- 2+ years of management experience, including training, mentoring, and accountability for results.
- Extensive experience managing regulatory operations for a large therapeutic study portfolio.
- IND submissions experience and exposure to FDA inspections.
Responsibilities
- Lead & develop people (45%)
- Operations, study & site management (20%)
- Regulatory strategy & health authority interface
- Quality systems, audits & SOPs
- Ethics & participant protection (10%)
- Data & technology (5%)
Benefits
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Associate degree
