Regulatory Coordinator - Duke Cancer Institute
About The Position
The Duke Cancer Institute (DCI) is looking for a Regulatory Coordinator to join our Oncology Clinical Research Unit (CRU) supporting the Bone Marrow Transplant, Hematologic Malignancies, and Cellular Therapy Clinical Research Programs. In this role, you will be at the center of complex, cutting‑edge oncology research, ensuring regulatory excellence and participant safety across multiple clinical trials, including investigator‑initiated and industry‑sponsored studies involving investigational products. If you enjoy working in a highly collaborative environment, navigating regulatory pathways, and contributing directly to life‑saving cancer research, this role offers deep exposure to FDA, IRB, and institutional processes while allowing you to grow as a subject‑matter expert in oncology clinical research.
Requirements
- Associate’s degree
- Minimum of two (2) years of research or regulatory experience in a clinical research setting.
- Completion of the DOCR North Carolina state‑approved Clinical Research Apprenticeship Program may substitute for one year of experience
- 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
- a wide array of family-friendly and cultural programs
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Associate degree
