Regulatory Coordinator - Duke Cancer Institute
About The Position
The Duke Cancer Institute (DCI) is seeking a Regulatory Coordinator to join its Oncology Clinical Research Unit (CRU), specifically supporting the Bone Marrow Transplant, Hematologic Malignancies, and Cellular Therapy Clinical Research Programs. This role is central to complex, cutting-edge oncology research, focusing on ensuring regulatory excellence and participant safety across various clinical trials, including investigator-initiated and industry-sponsored studies involving investigational products. The position offers significant exposure to FDA, IRB, and institutional processes, providing an opportunity to develop into a subject-matter expert in oncology clinical research within a highly collaborative environment. The DCI is an NCI-designated Comprehensive Cancer Center and a national leader in oncology research, innovation, and patient care, with the CRU providing centralized infrastructure and expert support for high-impact clinical trials.
Requirements
- Associate’s degree
- Minimum of two (2) years of research or regulatory experience in a clinical research setting
- Proficiency with clinical research management systems (e.g., OnCore, eREG, iRIS)
- Strong written and verbal communication skills
Nice To Haves
- Prior experience in oncology clinical trials
- Experience supporting complex, interventional, or investigator-initiated studies
- Familiarity with FDA regulatory submissions and IRB processes
- Experience working with industry sponsors and/or CROs
Responsibilities
- Manage regulatory operations for complex oncology studies by preparing, submitting, and maintaining FDA, IRB, and institutional documentation in collaboration with Principal Investigators (PIs), ORAQ, sponsors, and internal stakeholders
- Ensure compliance and audit readiness by maintaining complete regulatory binders, supporting monitoring and audit visits, responding to findings, and implementing corrective actions
- Coordinate study and site management activities including site initiation, monitoring, close-out, document storage, and sponsor/CRO communication using OnCore and eREG systems
- Apply and interpret regulatory, institutional, and federal requirements to protocols, consent documents, SOPs, and operational plans, including support for international studies
- Contribute to team leadership and training by mentoring peers, developing tools or resources, leading multidisciplinary meetings, and supporting process improvement initiatives
Benefits
- Comprehensive and competitive medical and dental care programs
- Generous retirement benefits
- Wide array of family-friendly and cultural programs
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Associate degree
Number of Employees
101-250 employees
