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 (DCI) Adult Bone Marrow Transplant, Hematologic Malignancies & Cellular Therapy Clinical Research Program (BMT) is looking for a Regulatory & Safety Operations Manager to lead day‑to‑day regulatory and safety operations across a complex portfolio of oncology clinical trials and research studies. You’ll be the go‑to expert for IND submissions, FDA interactions, and institutional policies—guiding multiple study teams through startup, maintenance, audits, and closeout in partnership with the Oncology Clinical Research Unit (CRU).

In this role, you will:

• Mentor and manage a high‑performing regulatory team, shaping processes and SOPs that keep studies inspection‑ready.
• Serve as a senior resource to PIs and study staff on U.S. and international regulatory compliance, safety reporting, and document control.
• Coordinate sponsor/CRO communications and site visits, translate scientific proposals into protocol elements for complex investigator‑initiated studies, and ensure institutional and federal compliance across the portfolio.

If you’re energized by building scalable processes, coaching talent, and ensuring the highest standards of patient safety and regulatory integrity, this is a chance to make a visible impact on innovative cancer research at Duke.

Minimum Requirements:

• Education/Training: Associate’s degree required.
• Experience: Minimum 6 years of research or regulatory experience. Completion of the DOCR North Carolina state‑approved Clinical Research Apprenticeship may substitute for 1 year of required experience. A Bachelor’s degree may substitute for 2 years of required experience.
• Skills: Proficient with computing software and web‑based applications (e.g., Microsoft Office and electronic medical record). Strong interpersonal and communication skills to get work done effectively.

Preferred Qualifications:

• Oncology and/or clinical research experience, education, or training.
• 2+ years of management experience, including training, mentoring, and accountability for results.
• Extensive experience managing regulatory operations for a large therapeutic study portfolio.
• IND submissions experience and exposure to FDA inspections.

Other Requirements:

• Ability to navigate complex stakeholder environments (PIs, sponsors/CROs, DSMBs, IRBs, institutional offices).
• Availability for occasional early/late meetings aligned to sponsor timelines and global collaborators; periodic support for audits/inspections.
• Compliance with all Duke and protocol‑specific training/certifications; maintain currency on SOPs, regulations, and protocol requirements.

Be Bold.

What you’ll do:

Lead & develop people (45%)

• Lead, supervise, and manage regulatory/safety staff: hiring, onboarding, workload allocation, cross‑training, time‑off approvals, and performance reviews.
• Set clear, measurable goals; monitor quality and timeliness; provide coaching, mentoring, and career development.
• Foster a culture of open communication, feedback, inclusion, and continuous learning; encourage participation in professional development (e.g., Research Wednesdays, RPN, external events).
• Represent the program on committees/workgroups; navigate Duke clinical research processes and stakeholders to drive results.
• Lead change adoption across multiple study teams; apply advanced TA/clinical research expertise to remove roadblocks and solve cross‑team problems.
• Train others to communicate effectively; facilitate resolution of team dynamics and cross‑functional issues.

Operations, study & site management (20%)

• Oversee sponsor/CRO communications and site visits; ensure consistent, professional, and timely responses.
• Own use of systems and reports (e.g., CTMS/eReg/eIRB) to manage protocol lifecycles; maintain complete, inspection‑ready study‑level documentation for interventional/procedural trials.
• Drive feasibility and site participation decisions; develop processes to assess feasibility across the portfolio.
• Translate PI scientific proposals into protocol elements for complex investigator‑initiated studies involving multiple PIs or teams; apply a solid grasp of study designs.
• Ensure portfolio compliance with institutional requirements and policies; implement operational plans across teams/sites.
• Lead study closeout planning and execution across multiple teams.

Regulatory strategy & health authority interface

• Serve as program expert for IND submissions and FDA interactions; guide junior staff in addressing FDA questions and reviews.
• Provide oversight and quality control for submissions to FDA and other agencies (initials, annual reports, amendments).
• Navigate international requirements: coordinate with foreign agencies/partners to develop/obtain compliant documentation; advise teams on global studies.
• Recognize when agreements (e.g., CDAs, MTAs, data sharing) are needed; coordinate with study teams and Duke offices to facilitate execution.

Quality systems, audits & SOPs

• Prepare teams proactively for monitoring visits and audits; lead CAPA development and follow‑through.
• Develop, roll out, and train on SOPs and work instructions; monitor adherence and continuously improve processes.
• Lead effective cross‑team meetings; ensure crisp communication channels and escalation pathways.

Ethics & participant protection (10%)

• Clarify professional guidelines and codes of ethics related to regulatory/safety in clinical research; ensure adherence to policies, SOPs, and protocol requirements.
• Oversee and train teams on consent plans/documents and IRB submissions; ensure timely, accurate safety reporting to sponsors and agencies.

Data & technology (5%)

• Innovate with technology to streamline regulatory processes (templates, trackers, dashboards); train staff on tools and best practices.

Choose Duke.

At the Duke Cancer Institute, you’ll join a nationally recognized research enterprise united by a mission to accelerate discoveries that improve the lives of people with cancer. You’ll collaborate with world‑class clinicians and scientists in a learning‑oriented environment that prizes excellence, inclusion, and innovation—living our promise of Cancer Care as It Should Be.

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.