Irb Coordinator Jobs

The Institutional Review Board (IRB) Coordinator supports the UCSF Office of Ethics and Compliance and the UCSF mission to advance health worldwide. The Coordinator does this by working closely with physicians, research scientists and study personnel from UCSF and its affiliates to administer, coordinate and facilitate the review and approval of complex biomedical and behavioral research studies that are reviewed by a panel of experts at convened “full committee” meetings of the IRB. The Coordinator must be able to perform a thoughtful initial review of these scientific protocols, identify problematic areas that may require additional clarification, and determine which IRB members have the specific expertise to be able to conduct a review of the science. In addition, the Coordinator must be able to clearly convey committee members’ concerns to the scientists proposing the research, communicate researchers’ responses back to the IRB committee members and ensure that the research activities are fully compliant with the federal regulations governing human subjects research. This entails an advanced understanding of the study protocol and as well as a thorough familiarity with federal and state regulations related to the human subjects in research. In some cases, with minimal risk studies, and depending on the incumbent, the Coordinator will also serve as designated IRB reviewer with authority to approve or require changes to the research.
The IRB Coordinator is responsible for screening greater than minimal risk and minimal human research studies. Uses skills as a seasoned, experienced research compliance professional with a full understanding of industry practices and organization policies / procedures to apply federal, state, and university regulations, policies, and guidelines, and promote best practices. Interacts frequently with investigators, persons in other organizational departments, and occasionally persons outside the University. Interactions require the use of tact and independent judgment, knowledge of standards and best practices, and counseling to resolve a wide range of research compliance issues. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Errors or omissions may ultimately put research subjects at undue risk and/or compromise the institution’s assurance of regulatory compliance with the federal government.

• Advising faculty and staff on how their projects, programs and applications can best comply with ethical, regulatory, and procedural requirements for the conduct of human research
• Reviewing, analyzing, and implementing UCSF policies and guidance for the protection of the safety and welfare of human research participants and preparing and implementing procedures as needed
• As needed, consult with IRB chairs and senior HRPP staff regarding strategies for handling complex new programs and applications
• Based on independent judgment, return applications to faculty/staff for changes that should be made before the applications are forwarded to the IRB for formal review
• Participating in deliberations during IRB meetings as an ex officio, nonscientist voting member, providing IRB chairs, vice chairs and members with regulatory, ethical and policy guidance as well as specific information about individual research studies
• Composing a large volume of in-depth analytical correspondence based on the IRB deliberations and issuing approval notices based on conditions imposed by the IRB
• Screening and editing new greater than minimal risk studies, providing extensive feedback and guidance to research team members and IRB members
• Analyzing greater than minimal risk and minimal risk studies, ensuring that the research protocol complies with all relevant federal and State regulations, University policies, and HRPP procedures

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