Research - Laboratory/Non-Laboratory, Staff/Administrative
Note: this position is open to remote work
Under the supervision of the Institutional Review Board (IRB) Manager, the Expedited/Exempt/GESCR Coordinator will screen initial review, modification, and continuing review applications for expedited Institutional Review Board (IRB) review, Gamete, Embryo and Stem Cell Research (GESCR) Committee review, or exempt determinations. In many cases, and depending on the individual, the Coordinator will also serve as designated IRB reviewer with authority to approve or require changes to the research. The Coordinator will screen applications for completeness, level of review needed, and compliance with regulations and guidelines; return applications with stipulations if changes are needed; and independently review the submission or when necessary, assign completed applications to IRB chairs and members or GESCR committee chairs or members for formal review.
The Coordinator will be responsible for creating GESCR committee meeting agendas and managing meetings. The individual will analyze and evaluate Committee decisions to ensure compliance with applicable regulations, policies and procedures. If any part of the decision is non-compliant, it is the responsibility for the Coordinator to take corrective action. The Coordinator is the person ultimately responsible for all IRB committee activities related to these studies, such as drafting correspondence to investigators, reviewing investigator responses, assisting with developing and improving systems and procedures for review, educating investigators and members.
The Coordinator writes formal correspondence to the investigator based on both the Committee's decisions and his or her own analysis of the protocol, reviews the investigator's response, and determines the next steps (either soliciting more information from the investigator, completing the review, or forwarding the response to the Committee members for further consideration). At each step the Coordinator must evaluate researchers' and members' concerns and responses and advise them of federal, state, and local regulations and guidance that limit the committee's decisions.
Internal Number: 3119608
About University of California, San Francisco
The University of California, San Francisco (UCSF) is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and high-quality patient care. It is the only UC campus in the 10-campus system dedicated exclusively to the health sciences.