Duke University
Regulatory Coordinator, Senior - Duke Cancer Institute
Duke University, Durham, North Carolina, United States, 27703
Regulatory Coordinator, Senior - Duke Cancer Institute
Join Duke University as a Regulatory Coordinator, Senior – leading day‑to‑day regulatory and safety operations for oncology clinical trials at the Duke Cancer Institute’s Oncology Clinical Research Unit (CRU).
Location: Durham, North Carolina
Salary: $69,362 – $110,658 annually
What You’ll Do
Direct and oversee regulatory submissions including consent forms, protocols, and continuing reviews to the Institutional Review Board (IRB).
Manage study‑level documentation such as regulatory binders, enrollment logs, patient registration, and safety reports.
Ensure compliance with institutional requirements, NIH Public Access policy, clinicaltrials.gov (ct.gov), and Research Data Security Plans.
Lead and mentor staff, providing coaching, performance reviews, and fostering professional development.
Collaborate with sponsors and contract research organizations (CROs) on regulatory and safety issues; prepare for audits and monitoring visits.
Oversee adverse event reporting and ensure timely submission of safety documentation.
Create a team culture that fosters open communication, motivates staff, and encourages creativity.
Minimum Qualifications
Associate’s degree.
Six years of research or regulatory experience.
Completion of the DOCR Clinical Research Apprenticeship may substitute for one year.
Bachelor’s degree may substitute for two years of experience.
Preferred Qualifications
Bachelor’s degree.
Recognized expertise in regulatory submissions for complex therapeutic studies.
Two years of management experience (training, mentoring, accountability).
Experience working with industry sponsors and CROs.
Oncology experience.
Anticipated Pay Range Duke University provides an annual base salary range for this position of USD $69,362.00 to USD $110,658.00. Total compensation includes comprehensive medical and dental care programs, generous retirement benefits, and a wide array of family‑friendly and cultural programs.
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 accommodation requests will be provided by each hiring department.
Equal Opportunity Statement 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, sex (including pregnancy and pregnancy related conditions), sexual orientation or military status.
Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. All members of our community have a responsibility to uphold these values.
Referrals increase your chances of interviewing at Duke University by 2×.
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Location: Durham, North Carolina
Salary: $69,362 – $110,658 annually
What You’ll Do
Direct and oversee regulatory submissions including consent forms, protocols, and continuing reviews to the Institutional Review Board (IRB).
Manage study‑level documentation such as regulatory binders, enrollment logs, patient registration, and safety reports.
Ensure compliance with institutional requirements, NIH Public Access policy, clinicaltrials.gov (ct.gov), and Research Data Security Plans.
Lead and mentor staff, providing coaching, performance reviews, and fostering professional development.
Collaborate with sponsors and contract research organizations (CROs) on regulatory and safety issues; prepare for audits and monitoring visits.
Oversee adverse event reporting and ensure timely submission of safety documentation.
Create a team culture that fosters open communication, motivates staff, and encourages creativity.
Minimum Qualifications
Associate’s degree.
Six years of research or regulatory experience.
Completion of the DOCR Clinical Research Apprenticeship may substitute for one year.
Bachelor’s degree may substitute for two years of experience.
Preferred Qualifications
Bachelor’s degree.
Recognized expertise in regulatory submissions for complex therapeutic studies.
Two years of management experience (training, mentoring, accountability).
Experience working with industry sponsors and CROs.
Oncology experience.
Anticipated Pay Range Duke University provides an annual base salary range for this position of USD $69,362.00 to USD $110,658.00. Total compensation includes comprehensive medical and dental care programs, generous retirement benefits, and a wide array of family‑friendly and cultural programs.
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 accommodation requests will be provided by each hiring department.
Equal Opportunity Statement 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, sex (including pregnancy and pregnancy related conditions), sexual orientation or military status.
Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. All members of our community have a responsibility to uphold these values.
Referrals increase your chances of interviewing at Duke University by 2×.
#J-18808-Ljbffr