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. The Duke Cancer Institute’s Oncology Clinical Research Unit (CRU) is seeking a Regulatory and Safety Operations Lead to join our Central Startup Activation Team (A-Team). In this role, you will lead day-to-day regulatory and safety operations for multiple, complex oncology clinical trials and research studies, including those involving Investigational Products (IP). Your work will ensure compliance, streamline processes, and support groundbreaking cancer research that impacts patient care.
Requirements
- Associate’s degree.
- Six years of research or regulatory experience.
- Completion of DOCR Clinical Research Apprenticeship may substitute for one year.
- Bachelor’s degree may substitute for two years of experience.
Nice To Haves
- Bachelor’s degree.
- Recognized expertise in regulatory submissions for complex therapeutic studies.
- Two years of management experience (training, mentoring, accountability).
- Experience working with industry sponsors and CROs.
- Oncology experience.
Responsibilities
- Direct and oversee regulatory submissions including consent forms, protocols, and continuing reviews to the IRB.
- Manage study-level documentation such as regulatory binders, enrollment logs, patient registration, and safety reports.
- Ensure compliance with institutional requirements, NIH Public Access policy, ct.gov, and Research Data Security Plans.
- Lead and mentor staff, providing coaching, performance reviews, and fostering professional development.
- Collaborate with sponsors and CROs on regulatory and safety issues; prepare for audits and monitoring visits.
- Oversee adverse event reporting and ensure timely submission of safety documentation.
- Create a team culture that fosters open communication, motivates staff, and encourages creativity.
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
Number of Employees
5,001-10,000 employees
