Regulatory Coordinator - Duke Cancer Institute

Job description

School of Medicine: 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. Be You. 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. Minimum 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 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 Be Bold. 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 (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 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. Choose Duke. The Duke Cancer Institute is a NCI‑designated Comprehensive Cancer Center and a national leader in oncology research, innovation, and patient care. Within DCI, the Oncology Clinical Research Unit provides centralized infrastructure and expert support for high‑impact clinical trials that shape the future of cancer treatment. At Duke, you will be part of a mission‑driven community that values discovery, collaboration, and excellence . You will work alongside renowned investigators and dedicated research professionals while benefiting from Duke’s commitment to professional development, internal mobility, and work‑life balance. Job Code: 00001219 REGULATORY COORD Job Level: 52 Anticipated Pay Range: Duke University provides an annual base salary range for this position as USD $61,026.00 to USD $101,959.00. 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. 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: 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, sex (including pregnancy and pregnancy- related conditions), sexual orientation, or military status. Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values. 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: ; phone: 919-668-1267).