Regulatory Coordinator - 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 Oncology Clinical Research Unit (CRU) within the Duke Cancer Institute's Brain Tumor Center (BTC) Clinical Research Program is seeking a Regulatory Coordinator to join our team. In this role, you will play a critical part in supporting complex oncology clinical trials, ensuring regulatory compliance. This position will also serve a key role to ensure data integrity, and patient safety across multiple studies.

You will work at the intersection of regulatory operations, clinical data management, and safety reporting-supporting cutting-edge brain tumor research. Your work will directly contribute to the advancement of innovative therapies while collaborating with multidisciplinary teams across Duke.

Minimum Requirements:

• Associate's degree required
• Minimum of two (2) years of research or regulatory experience
• Completion of the DOCR North Carolina state-approved Clinical Research Apprenticeship may substitute for one year of experience
• Proficiency in Microsoft Office and web-based applications, including electronic medical records

Preferred Qualifications:

• Oncology or clinical research experience
• Experience preparing clinical trial data for monitoring visits
• Experience consenting patients for non-therapeutic trials
• Strong organizational skills with the ability to manage multiple complex studies simultaneously
• Excellent written and verbal communication skills
• Ability to quickly learn new clinical research systems (e.g., iMedris, OnCore, Forte eResearch)
• Experience with regulatory submissions (IRB, IND, FDA forms) and clinical trial compliance

Other Requirements:

• Ability to maintain required certifications and training for clinical research compliance
• Adherence to institutional policies, SOPs, and federal regulations
• This position is hybrid.

Be Bold.

• Lead regulatory operations by preparing and submitting IRB applications, amendments, continuing reviews, safety reports, and maintaining regulatory binders and compliance documentation
• Manage clinical research data and biospecimens by coordinating collection, documentation, quality assurance, and reporting across multiple oncology studies
• Ensure study compliance and audit readiness by preparing for monitoring visits, addressing findings, and maintaining adherence to federal, sponsor, and institutional requirements
• Maintains participant level documentation for all studies, and/or require access to the Duke HER.
• Maintains study level documentation, including regulatory binders, enrollment logs, and patient registration in the system of records.
• Recruits patients for clinical trials by running reports to identify prescreen eligible patients, and builds or maintains schedule to coordinate in-clinic or eConsent by data staff.
• Provide data in response to "Data pull requests" by clinicians /researchers for IRB approved protocols in a timely manner.
• Coordinate cross-functional collaboration with sponsors, investigators, clinical teams, and oversight committees to support regulatory and safety processes
• Drive data quality and innovation by developing SOPs, contributing to data lifecycle planning, supporting FAIR data practices, and creating reports and visualizations for stakeholders

Choose Duke.

At Duke University and the Duke Cancer Institute, you'll be part of a world-renowned research environment dedicated to advancing cancer care and improving patient outcomes. The Brain Tumor Center Clinical Research Program is at the forefront of innovation, bringing together leading clinicians, researchers, and data experts to tackle some of the most complex challenges in oncology.

This role offers the opportunity to contribute directly to groundbreaking clinical trials while growing your expertise in regulatory science, data management, and clinical research operations. You'll work alongside a collaborative and mission-driven team committed to excellence, discovery, and patient-centered care.