Regulatory Coordinator - Duke Cancer Institute

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.

The Duke Cancer Institute (DCI) is looking for a Regulatory Coordinator to join the 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.

About the role

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

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
• Proficiency with clinical research management systems (e.g., OnCore, eREG, iRIS)
• Strong written and verbal communication skills

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

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.

About the team

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.

Pay

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.

Benefits

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.