Regulatory Coordinator - Duke Cancer Institute
Duke Clinical Research Institute, Durham, NC, United States
The Duke Cancer Institute (DCI) is looking for a
Regulatory Coordinator
to join our Oncology Clinical Research Unit (CRU) supporting the Bone Marrow Transplant, Hematologic Malignancies, and Cellular Therapy Clinical Research Programs. In this role, you will play a central part in complex, cutting‑edge oncology research, ensuring regulatory excellence and participant safety across multiple clinical trials, including investigator‑initiated and industry‑sponsored studies involving investigational products.
If you enjoy working in a highly collaborative environment, navigating regulatory pathways, and contributing directly to lifesaving cancer research, this role offers deep exposure to FDA, IRB, and institutional processes while allowing you to grow as a subject‑matter expert in oncology clinical research.
Minimum Requirements
Associate's degree
Minimum of two (2) years of research or regulatory experience in a clinical research setting. Completion of the DOCR North Carolina state‑approved Clinical Research Apprenticeship Program may substitute for one year of experience.
Preferred Qualifications
Prior experience in oncology clinical trials
Experience supporting complex, interventional, or investigator‑initiated studies
Familiarity with FDA regulatory submissions and IRB processes
Experience working with industry sponsors and/or CROs
Other Requirements
Proficiency with clinical research management systems (e.g., OnCore, eREG, iRIS)
Strong written and verbal communication skills
Key Responsibilities
Manage regulatory operations for complex oncology studies
by preparing, submitting, and maintaining FDA, IRB, and institutional documentation in collaboration with Principal Investigators (PIs), ORAQ, sponsors, and internal stakeholders.
Ensure compliance and audit readiness
by maintaining complete regulatory binders, supporting monitoring and audit visits, responding to findings, and implementing corrective actions.
Coordinate study and site management activities
including site initiation, monitoring, closeout, document storage, and sponsor/CRO communication using OnCore and eREG systems.
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.
How your time is typically spent: This role is primarily focused on operations, study, and site management (approximately 70 %), with dedicated effort supporting ethics, regulatory submissions, and safety reporting (15 %), communication and collaboration with study teams and stakeholders (10 %), and leadership and professional development activities (5 %).
Success in this role requires strong organizational awareness within academic clinical research, a solid ethical foundation, resilience in a fast‑paced environment, advanced problem‑solving skills, and the ability to communicate effectively across multidisciplinary teams to achieve shared research objectives.
Compensation and Benefits
Anticipated pay range: USD $59,829.00 to $99,960.00 per year.
Additional compensation includes comprehensive medical and dental coverage, retirement benefits, and a variety of family‑friendly and cultural programs.
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, pregnancy and pregnancy‑related conditions, sexual orientation, or military status. Duke aspires to create a community built on collaboration, innovation, creativity, and belonging.
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: DAAS@duke.edu; phone: 919‑668‑1267).
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Regulatory Coordinator
to join our Oncology Clinical Research Unit (CRU) supporting the Bone Marrow Transplant, Hematologic Malignancies, and Cellular Therapy Clinical Research Programs. In this role, you will play a central part in complex, cutting‑edge oncology research, ensuring regulatory excellence and participant safety across multiple clinical trials, including investigator‑initiated and industry‑sponsored studies involving investigational products.
If you enjoy working in a highly collaborative environment, navigating regulatory pathways, and contributing directly to lifesaving cancer research, this role offers deep exposure to FDA, IRB, and institutional processes while allowing you to grow as a subject‑matter expert in oncology clinical research.
Minimum Requirements
Associate's degree
Minimum of two (2) years of research or regulatory experience in a clinical research setting. Completion of the DOCR North Carolina state‑approved Clinical Research Apprenticeship Program may substitute for one year of experience.
Preferred Qualifications
Prior experience in oncology clinical trials
Experience supporting complex, interventional, or investigator‑initiated studies
Familiarity with FDA regulatory submissions and IRB processes
Experience working with industry sponsors and/or CROs
Other Requirements
Proficiency with clinical research management systems (e.g., OnCore, eREG, iRIS)
Strong written and verbal communication skills
Key Responsibilities
Manage regulatory operations for complex oncology studies
by preparing, submitting, and maintaining FDA, IRB, and institutional documentation in collaboration with Principal Investigators (PIs), ORAQ, sponsors, and internal stakeholders.
Ensure compliance and audit readiness
by maintaining complete regulatory binders, supporting monitoring and audit visits, responding to findings, and implementing corrective actions.
Coordinate study and site management activities
including site initiation, monitoring, closeout, document storage, and sponsor/CRO communication using OnCore and eREG systems.
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.
How your time is typically spent: This role is primarily focused on operations, study, and site management (approximately 70 %), with dedicated effort supporting ethics, regulatory submissions, and safety reporting (15 %), communication and collaboration with study teams and stakeholders (10 %), and leadership and professional development activities (5 %).
Success in this role requires strong organizational awareness within academic clinical research, a solid ethical foundation, resilience in a fast‑paced environment, advanced problem‑solving skills, and the ability to communicate effectively across multidisciplinary teams to achieve shared research objectives.
Compensation and Benefits
Anticipated pay range: USD $59,829.00 to $99,960.00 per year.
Additional compensation includes comprehensive medical and dental coverage, retirement benefits, and a variety of family‑friendly and cultural programs.
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, pregnancy and pregnancy‑related conditions, sexual orientation, or military status. Duke aspires to create a community built on collaboration, innovation, creativity, and belonging.
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: DAAS@duke.edu; phone: 919‑668‑1267).
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