Regulatory Coordinator, Senior - Duke Cancer Institute
About The Position
The Duke Cancer Institute’s Genitourinary Clinical Research Program (GU) is seeking a Regulatory and Safety Operations Lead to join our team. In this role, you will lead the day-to-day regulatory and safety operations for multiple, complex oncology clinical trials, including those involving Investigational Products (IP). You will play a critical role in ensuring compliance, maintaining documentation, and supporting the success of groundbreaking cancer research. You will: Oversee regulatory submissions and documentation for clinical trials. Ensure compliance with institutional, federal, and sponsor requirements. Lead and mentor a team of regulatory professionals. Collaborate with sponsors, CROs, and internal stakeholders to resolve regulatory and safety issues. At Duke Cancer Institute, we live by our core value: “Cancer Care as It Should Be.” Joining our team means contributing to cutting-edge oncology research that impacts patient care worldwide. You’ll work in a collaborative environment that values innovation, ethics, and excellence. Duke offers a competitive benefits package and opportunities for professional growth in one of the nation’s leading academic research institutions.
Requirements
- Associate’s degree required. Bachelor’s degree strongly preferred.
- Six years of research or regulatory experience.
- Specific Regulatory experience required: Experience with industry sponsors and CROs; Proven ability to manage a large, complex portfolio (30+ therapeutic studies).
- Completion of the DOCR Clinical Research Apprenticeship may substitute for one year.
- A Bachelor’s degree may substitute for two years of experience.
Nice To Haves
- Oncology experience preferred
- Academic clinical research experience strongly preferred.
Responsibilities
- Direct regulatory operations for oncology clinical trials, including IRB submissions, consent forms, protocols, and continuing reviews.
- Manage compliance with institutional policies, NIH Public Access, ct.gov, and Research Data Security Plans.
- Lead safety reporting, including timely submission of Adverse Event Reports per institutional and sponsor guidelines.
- Supervise and develop staff, providing coaching, performance reviews, and career development opportunities.
- Prepare for audits and monitoring visits, addressing findings and ensuring corrective actions.
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
