Regulatory Coordinator, Senior - Duke Cancer Institute

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’s Oncology Clinical Research Unit (CRU) is seeking a Regulatory and Safety Operations Lead to join our Central Startup Activation Team (A-Team). In this role, you will lead day-to-day regulatory and safety operations for multiple, complex oncology clinical trials and research studies, including those involving Investigational Products (IP). Your work will ensure compliance, streamline processes, and support groundbreaking cancer research that impacts patient care.

Be Bold.

What You’ll Do:

• Direct and oversee regulatory submissions including consent forms, protocols, and continuing reviews to the IRB.
• Manage study-level documentation such as regulatory binders, enrollment logs, patient registration, and safety reports.
• Ensure compliance with institutional requirements, NIH Public Access policy, ct.gov, and Research Data Security Plans.
• Lead and mentor staff, providing coaching, performance reviews, and fostering professional development.
• Collaborate with sponsors and CROs on regulatory and safety issues; prepare for audits and monitoring visits.
• Oversee adverse event reporting and ensure timely submission of safety documentation.
• Create a team culture that fosters open communication, motivates staff, and encourages creativity.

Minimum Qualifications:

• Associate’s degree.
• Six years of research or regulatory experience.
• Completion of DOCR Clinical Research Apprenticeship may substitute for one year.
• Bachelor’s degree may substitute for two years of experience.

Preferred Qualifications:

• Bachelor’s degree.
• Recognized expertise in regulatory submissions for complex therapeutic studies.
• Two years of management experience (training, mentoring, accountability).
• Experience working with industry sponsors and CROs.
• Oncology experience.

Choose Duke.

Join a team that embodies Duke’s core value: Cancer Care as It Should Be. At Duke Cancer Institute, you’ll work alongside leading experts in oncology research, contributing to studies that transform patient care. We offer a collaborative environment, professional growth opportunities, and access to Duke University’s competitive benefits package.

Anticipated Pay Range:

Duke University provides an annual base salary range for this position as USD $69,362.00 to USD $110,658.00. 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 https://hr.duke.edu/benefits/

Job Code: 00001220 REGULATORY COORD, SR

Job Level: 53

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 provision for requests for reasonable accommodation will be provided by each hiring department.