Oncology Regulatory Coordinator — Trials & Compliance

Duke University; Durham (NC); On-site; USD 61,000 - 102,000; Full time

Job summary

The Duke Cancer Institute (DCI) is seeking a Regulatory Coordinator to support the Oncology Clinical Research Unit, focusing on regulatory excellence and participant safety across multiple trials, including interventional studies and industry-sponsored research.

You will navigate regulatory pathways, contribute to FDA, IRB, and institutional processes, and grow as an oncology clinical research subject-matter expert in a collaborative environment at Duke.

Qualifications

• Associate’s degree and at least 2 years of research or regulatory experience in a clinical research setting.
• Completion of DOCR North Carolina state-approved Clinical Research Apprenticeship Program may substitute for one year of experience.
• Preferred: oncology clinical trials experience.
• Experience with FDA regulatory submissions and IRB processes.
• Experience working with industry sponsors and/or CROs.
• Proficiency with clinical research management systems (OnCore, eREG, iRIS).

Responsibilities

• Manage regulatory operations for complex oncology studies by preparing, submitting, and maintaining FDA, IRB, and institutional documentation with PIs, ORAQ, sponsors, and internal stakeholders.
• Ensure compliance and audit readiness by maintaining regulatory binders, supporting monitoring and audit visits, responding to findings, and implementing corrective actions.
• Coordinate study and site management activities including site initiation, monitoring, close-out, document storage, and sponsor/CRO communication using OnCore and eREG.
• Apply and interpret regulatory, institutional, and federal requirements to protocols, consent documents, SOPs, and operational plans, including support for international studies.
• Contribute to team leadership and training by mentoring peers, developing tools or resources, leading multidisciplinary meetings, and supporting process improvement initiatives.

Skills

Regulatory experience

Oncology trials

Clinical research

Communication skills

Education

Associate’s degree

Tools

OnCore

eREG

iRIS

Job description

The Duke Cancer Institute (DCI) is seeking a Regulatory Coordinator to support the Oncology Clinical Research Unit, focusing on regulatory excellence and participant safety across multiple trials, including interventional studies and industry-sponsored research.

You will navigate regulatory pathways, contribute to FDA, IRB, and institutional processes, and grow as an oncology clinical research subject-matter expert in a collaborative environment at Duke.