Regulatory Coordinator - Duke Cancer Institute

Duke Careers•Durham, NC

2d•$59,829 - $99,960•Hybrid

About The Position

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.

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
Ability to maintain required certifications and training for clinical research compliance
Adherence to institutional policies, SOPs, and federal regulations

Nice To Haves

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

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