Regulatory Coordinator - Duke Cancer Institute

About the role

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.

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

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