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IRB Regulatory Compliance Expert

2 weeks ago

Nelson, Nelson, New Zealand SRA International Full time

SRA International is seeking a highly motivated and detail-oriented professional to fill the IRB Coordinator position. In this role, you will be responsible for ensuring that all research protocols involving human subjects are conducted in accordance with federal regulations, state laws, and University policies and procedures. The ideal candidate will have a strong understanding of human subject research protections and IRB operations, including knowledge of new or revised regulations and guidance issued by the Office for Human Subject Protections (OHRP), the Food and Drug Administration (FDA), the State of Illinois, and other regulatory agencies as applicable.

Responsibilities:

  1. Review and evaluate research protocols for compliance with federal and state regulations and UIC policy.
  2. Conduct regular audits to ensure adherence to established protocols and procedures.
  3. Develop and implement educational programs to educate researchers, faculty, staff, and students on human subject research protections and IRB regulations.
  4. Coordinate the preparation and submission of research protocol documents to the IRB for review and approval.
  5. Maintain accurate and detailed records of all interactions with researchers, investigators, and regulatory agencies.