Job Summary

The Institutional Review Board Assistant Coordinator supports the UCSF Office of Ethics and Compliance by working closely with physicians, research scientists and study personnel from UCSF and its affiliates to assist in the review and approval of modifications and continuing reviews associated with ongoing complex biomedical and social behavioral research studies. The Assistant Coordinator must be able to perform a thoughtful screening of proposed changes to approved research and identify problematic areas that may require additional clarification before review by the committee or Chair, ensure the submission receives the appropriate level of review, and clearly convey reviewers’ concerns to the scientists proposing the research, and communicate researchers’ responses back to the reviewer. This entails an understanding of the study protocol as well as a familiarity with federal and state regulations and University policies related to the protection of human subjects in research.

The Analyst also performs analytical and business tasks and serves multiple functions in support of the HRPP. The incumbent will complete a variety of complex duties, typically on a project basis; projects will be completed independently or under general supervision.  Responsibilities impact the HRPP and immediate office, and include IT and phone ticket requests, approval of affiliate access and submitting access forms to human resources, scheduling coordination and event planning, and taking meeting minutes. The Analyst   must maintain a high degree of confidentiality and exercise sound independent judgment. 

The IRB Assistant Coordinator uses research compliance concepts, and applies organization policies and procedures to pre-review (screen) moderately complex, minimal risk researchn protocols. Works independently in most cases without a great deal of supervision or oversight for routine or standard assignments. HIghlights potential issues of concern for committee Chair, Vice Chair and/or members to consider in their review of research protocols that qualify for review.

• Screen modification and continuing review proposals for adherence to federal regulations and local policies and ensure the correct level of review is applied. Occasionally screen minimal risk and exempt initial review submissions.
• Provide feedback and guidance to the research team as necessary to ensure that the proposal is complete and sufficient information is provided for review by the Chair or review board and write post-review comments or approval letters after the review.
• Ensure that regulatory determinations are appropriately documented in committee meeting minutes and approval letters.
• Advise investigators and study team members on how to properly prepare their submission, how to use iRIS (the online submission system), and advise on federal regulations and local and University policies
• Serve as first point of contact for phone and email inquiries to the HRPP office, either providing feedback to the inquiry or directing to the appropriate staff member.
• Performs complex analytical and business tasks typically on a project basis; completed independently or under general supervision.  Responsibilities impact the HRPP and immediate office, and include business operations, IT and phone ticket requests, approving affiliate access requests and submitting requests to human resources, scheduling coordination and event planning, and taking meeting minutes. The Analyst   must maintain a high degree of confidentiality and exercise sound independent judgment. 

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Under the supervision of the Institutional Review Board (IRB) Manager, the Coordinator will screen initial review, modification, and continuing review applications for expedited IRB review, Gamete, Embryo and Stem Cell Research (GESCR) Committee review, or exempt determinations.  In many cases, 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 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. Incumbent 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. 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, and other duties as assigned.

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.

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The IRB Analyst 2 uses research compliance concepts and applies organization policies and procedures to review and / or pre-review moderately complex, minimal risk research and screen for greater-than-minimal risk protocols. Works independently in most cases without a great deal of supervision or oversight for routine or standard assignments. Highlights potential issues of concern for committee Chair, Vice Chair and/or members to consider in their review of research protocols that qualify for  review.
 

• Assist in the efficient management of one of the five IRB committees responsible for reviewing and approving research involving the participation of human subjects.
• Screen modification and continuing review proposals for adherence to federal regulations and local policies and ensure the correct level of review is applied.
• Provide feedback and guidance to the research team as necessary to ensure that the proposal is complete and sufficient information is provided for review by the Chair or review board and write post-review comments or approval letters after the review.
• Ensure that regulatory determinations are appropriately documented in committee meeting minutes and approval letters.
• Advise investigators and study team members on how to properly prepare their submission, how to use iRIS (the online submission system), and advise on federal regulations and local and University policies
• Participate in full board convened meetings. Attend meeting, set up audio visual equipment, navigate through the online submission for members to view during the meeting, and take notes on the discussion.

The Institutional Review Board Analyst 2 supports the UCSF Office of Ethics and Compliance by working closely with physicians, research scientists and study personnel from UCSF and its affiliates to assist in the review and approval of modifications and continuing reviews associated with ongoing complex biomedical and social behavioral research studies that are reviewed by a panel of experts at a convened “full committee” meeting of the IRB. The IRB Analyst 2 must be able to perform a thoughtful screening of proposed changes to approved research and identify problematic areas that may require additional clarification before review by the committee, ensure the submission receives the appropriate level of review, and assist the Committee Coordinator to identify the specific expertise needed to conduct a review of the science. In addition, the IRB Analyst 2 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 assist the Committee Coordinator with both setting meeting agendas and finalizing meeting minutes. In addition, the IRB Analyst 2 will be a voting member of the IRB with responsibility for serving as reviewer to minor changes to research. This entails an understanding of the study protocol as well as a familiarity with federal and state regulations and University policies related to the protection of human subjects in research.

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The IRB Analyst 2 uses research compliance concepts and applies organization policies and procedures to pre-review moderately complex, minimal risk research greater-than-minimal risk protocols. Works independently in most cases without a great deal of supervision or oversight for routine or standard assignments. Highlights potential issues of concern for committee Chair, Vice Chair and/or members to consider in their review of research protocols that qualify for review.

• Assist in the efficient management of the IRB reliance program responsible for reviewing and approving research involving the participation of human subjects
• Screen requests to rely on an external IRB for adherence to federal regulations and local policies
• Provide feedback and guidance to the research team as necessary to ensure that the proposal is complete and sufficient information is provided for review by an external IRB and write acknowledgement letters
• Ensure that regulatory determinations are appropriately documented in acknowledgement letters
• Advise investigators and study team members on how to properly prepare their submission, how to use iRIS (the online submission system), and advise on federal regulations and local and University policies

The Institutional Review Board Analyst 2 supports the UCSF Office of Ethics and Compliance by working closely with physicians, research scientists and study personnel from UCSF and its affiliates to assist in the review and approval of complex biomedical and social behavioral research studies that are reviewed by an external IRB. The IRB Analyst 2 must be able to perform a thoughtful screening of the request to rely on an external IRB and identify problematic areas that may require additional clarification before review by the external IRB. In addition, the IRB Analyst 2 may be a voting member of the IRB and/ or Privacy Board with responsibility for serving as reviewer of HIPAA waivers. This entails an understanding of the study protocol as well as a familiarity with federal and state regulations and University policies related to the protection of human subjects in research.

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The Institutional Review Board Analyst (IRB Analyst) composes and revises operating procedures, policies, and guidelines.  Th IRB Analyst develops materials and conducts training for, and works alongside, the UCSF Human Research Protection Program (HRPP) reliance team, which conducts administrative and local context review of research where an external IRB is serving as the IRB of Record in lieu of the UCSF IRB or where the UCSF IRB is serving as the IRB of Record for an external site or investigator as allowed under regulation and UCSF policies and procedures.

The IRB Analyst uses advanced research compliance concepts, logical-thinking, advanced problem-solving and deductive skills to interpret highly complex and broad human research protections, National Institutes of Health (NIH), Food & Drug Administration (FDA), and other federal and state regulations, policies, and guidelines. The incumbent regularly works on highly complex human research compliance issues in performing administrative and local context reviews of research and advising the HRPP reliance team on same where analysis requires an in-depth evaluation of variable and numerous factors. The incumbent exercises judgment in selecting methods, techniques and evaluation criteria for the appropriate level of review and instructing other members of the reliance team on same, as required by regulation and policy, and anticipates and identifies problems and develops and implements the appropriate response and / or action. Serves as a technical/subject expert and adviser to department head.

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