Human Subject Research Specialist

4 days ago


Nelson, Nelson, New Zealand SRA International Full time

We are seeking a seasoned professional to join our team as an IRB Coordinator. In this role, you will be responsible for providing regulatory expertise and guidance to the Department of Surgery Research Director Institutional Review Board (IRBs). The ideal candidate will have a strong background in human subject research protections and IRB operations, including knowledge of new or revised regulations and guidance issued by the Office for Human Subject Protections (OHP), the Food and Drug Administration (FDA), the State of Illinois, and other regulatory agencies as applicable.

Duties and Responsibilities:

  1. Collaborate with researchers, faculty, staff, and students to ensure compliance with federal and state regulations and UIC policy.
  2. Develop and maintain comprehensive knowledge of human subject research protections and IRB regulations, including 45 CFR 46, 21 CFR 50 & 52, and other applicable federal and state regulations.
  3. Prepare and submit research protocol documents to the IRB for review and approval.
  4. Maintain accurate and detailed records of all interactions with researchers, investigators, and regulatory agencies.
  5. Communicate effectively with all stakeholders, including researchers, investigators, study sponsors, and regulatory agencies.

Preferred Qualifications:

  • Master's degree in a health care or regulatory related field desired.
  • Certification as an IRB Professional (CIP) desired.


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