Regulatory Coordinator - Duke Cancer Institute

Regulatory Coordinator – Oncology Clinical Research Unit The Oncology Clinical Research Unit (CRU) within the Duke Cancer Institute’s Brain Tumor Center (BTC) Clinical Research Program seeks 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. Responsibilities 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. 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. Benefits Anticipated pay range: USD $59,829.00 to USD $99,960.00. Duke University also 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. Job Code: 00001219 REGULATORY COORD Job Level: 52 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. 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: View email address on click.appcast.io; phone: View phone number on click.appcast.io). #J-18808-Ljbffr Duke University