Regulatory Coordinator - Duke Cancer Institute
Duke University, Durham, NC, United States
Regulatory Coordinator
In this role, you will be at the center of 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 life‑saving 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
As a Regulatory Coordinator, You Will
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, close‑out, 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.
Job Code: 00001219 REGULATORY COORD
Job Level: 52
Anticipated Pay Range:
Duke University provides an annual base salary range for this position as USD $59,829.00 to USD $99,960.00. Duke University considers factors such as (but not limited to) scope and responsibilities of the position; candidate's work experience, education/training, and key skills; internal peer equity; as well as market and organizational considerations when extending an offer.
Your total compensation goes beyond the dollars on your paycheck. Duke 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. Learn more at: https://hr.duke.edu/benefits/
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, (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: DAAS@duke.edu; phone: 919-668-1267).
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In this role, you will be at the center of 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 life‑saving 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
As a Regulatory Coordinator, You Will
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, close‑out, 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.
Job Code: 00001219 REGULATORY COORD
Job Level: 52
Anticipated Pay Range:
Duke University provides an annual base salary range for this position as USD $59,829.00 to USD $99,960.00. Duke University considers factors such as (but not limited to) scope and responsibilities of the position; candidate's work experience, education/training, and key skills; internal peer equity; as well as market and organizational considerations when extending an offer.
Your total compensation goes beyond the dollars on your paycheck. Duke 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. Learn more at: https://hr.duke.edu/benefits/
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, (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: DAAS@duke.edu; phone: 919-668-1267).
#J-18808-Ljbffr