Regulatory Coordinator - Duke Cancer Institute

Regulatory Coordinator 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. 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. Minimum Requirements Associate’s degree (or equivalent) 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. Preferred Qualifications 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. Other Requirements Proficiency with clinical research management systems (e.g., OnCore, eREG, iRIS). Strong written and verbal communication skills. As a Regulatory Coordinator, You Will Manage regulatory operations for complex oncology studies by preparing, submitting, and maintaining FDA, IRB, and institutional documentation in collaboration with Principal Investigators, 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. How your time is typically spent: This role is primarily focused on operations, study, and site management (approximately 70%), with dedicated effort supporting ethics, regulatory submissions, and safety reporting (15%), communication and collaboration with study teams and stakeholders (10%), and leadership and professional development activities (5%). Success in this role requires strong organizational awareness within academic clinical research, a solid ethical foundation, resilience in a fast‑paced environment, advanced problem‑solving skills, and the ability to communicate effectively across multidisciplinary teams to achieve shared research objectives. Your total compensation goes beyond the dollars on your paycheck. 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. Learn more at: Anticipated Pay Range: Duke University provides an annual base salary range for this position as USD $59,829.00 to USD $99,960.00. Duke University considers factors such as (but not limited to) scope and responsibilities of the position; candidate's work experience, education/training, and key skills; internal peer equity; as well as market and organizational considerations when extending an offer. Job Code: 00001219 REGULATORY COORD Job Level: 52 Equal Opportunity Employer: Duke is an Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, (including pregnancy and pregnancy related conditions), sexual orientation, or military status. Essential Physical Job Functions Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and reasonable accommodation(s) can be requested with Duke Access and Accommodations Services (email: View email address on click.appcast.io; phone: View phone number on click.appcast.io). #J-18808-Ljbffr Duke University