Senior Regulatory Coordinator, Neurosurgery

Work Arrangement:
Remote

Requisition Number: 276512

Regular or Temporary:
Regular

Location:

Durham, NC, US, 27710

Date:
Oct 20, 2026

School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe.

Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.
Senior Regulatory Coordinator

Be You.

The Neurosurgery Clinical Research Unit (NSU CRU) at Duke is seeking a Senior Regulatory Coordinator to join our team. In this role, you will help bring innovative neurosurgical, neurological, and spinal treatments and therapies to patients by coordinating complex clinical trials, some from bench to the bedside, conducting study startup through closeout.

You will play a key role in groundbreaking, first in human, brain/spine infusion drug and device studies from pediatric to adult subjects. If you are a motivated and talented research professional looking for the opportunity to get involved in a fast-paced, academic, medical, and scientific research environment, this is the place for you!

Minimum Requirements:

• Associate's degree.
• Minimum of six years of research experience. A bachelor’s degree may substitute for 2 years required.
• Completion of the DOCR North Carolina state approved Clinical Research Apprenticeship program may substitute for one year of required experience.
• Proficiency using Microsoft Office applications, web-based systems, and other research-related software applications.
• Ability to manage multiple studies and priorities simultaneously while maintaining attention to detail.
• Strong organizational, communication, and problem-solving skills.
• Ability to work collaboratively with investigators, sponsors, and research staff.

Preferred Qualifications:

• Regulatory research experience.
• Experience with Institutional Review Board (IRB) at Duke and external IRBs.
• Research-related education, training, or certification.
• Experience working with investigational products and complex clinical trials, collaborating with Duke Office of Regulatory Affairs and Quality (ORAQ), U.S. Food and Drug Administration (FDA), National Institute of Health (NIH), and other regulatory agencies.
• Experience with developing informed consents, protocols, supporting documents, and regulatory compliance activities.
• Ability to handle all regulatory requirements per study, i.e., Delegation of Authority (DOA) logs, training logs, approval letters, standard operating procedures (SOPs), adverse events (AE) reporting, budget and contract support.
• Familiarity with conducting internal monitoring according to the Duke Clinical Quality Management Program (CQMP) policy as well as preparation for external monitoring visits as well as study initiation visits and closeout visits.

Other Requirements:

• Basic Life Support (BLS) certification from the American Heart Association or Duke-approved equivalent course is required.
• Must maintain Duke and…