JOB OVERVIEW The Institutional Review Board (IRB) Administrator supports the UCSF Office of Ethics and Compliance and the UCSF mission to advance health worldwide. S/he 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 research studies that are reviewed by a panel of experts at convened 'full committee' meetings of the IRB. The Administrator will 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, s/he will be able to clearly convey committee members' concerns to the scientists proposing the research, communicate researchers' responses back to the IRB committee members, carefully summarize the deliberations of the committee in the meeting minutes, 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.
The IRB Administrator uses advanced research compliance concepts to interpret highly complex and broad regulations, policies and guidelines. Regularly works on highly complex research compliance issues where analysis requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques and evaluation criteria to anticipate and identify problems and develop and implement the appropriate response and/or action. Serves as a technical expert and advisor to both the IRB leadership and to directors of research centers and clinical departments. Responsibilities include the following:
* Efficient management of one of the five IRB committees responsible for reviewing and approving research involving the participation of human subjects * Primary responsibility for the oversight, administration and management of all IRB business assigned to the IRB, approximately 450 protocols annually. This responsibility includes ensuring that the research protocol complies with all relevant federal and State regulations, University policies, and Human Research Protection Program (HRPP) procedures * Primary responsibility for coordination and administration of the Benioff Children's Hospital (BCH) Oakland Research Review Committee (RRC), a long-standing scientific review committee that reviews studies referred for concerns about study design or planned research activities prior to IRB review, and is directly involved with facilitating communications between the RRC and study team, and the RRC and IRB Committee * Screening and serving as the Designated Expedited Committee Reviewer for new minimal risk research (Expedited and Exempt) that will be carried out primarily or solely at the BCH Oakland site or in the BCH Oakland surrounding communities * Screening and editing all new full committee studies submitted to IRB, and providing extensive feedback and guidance to research team members and IRB members * 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, records meeting minutes, and issuing approval notices based on conditions imposed by IRB * 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 * Training research staff in the preparation of applications, consent forms and recruitment materials, and being available for ongoing consultation and in-person presentations * 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.
HUMAN RESEARCH PROTECTION PROGRAM The Human Research Protection Program (HRPP) at UCSF, in partnership with the research community, is responsible for ensuring the ethical and equitable treatment of all human research subjects in studies conducted by UCSF faculty. The HRPP is also responsible for ensuring compliance with federal regulations, state laws and University polices as well as national standards for research involving human participants. The IRB is the major component of the UCSF HRPP that is a unit within the Office of Ethics and Compliance. The other two components of the HRPP are the Quality Improvement Unit (QIU) and the Human Gamete, Embryo and Stem Cell Research (GESCR) Committee. All three units provide education and training. The IRB and the QIU are supported by iRIS, which is a web-based submission, review and approval system.
ABOUT UCSF 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 excellence in patient care. It is the only campus in the 10-campus UC system dedicated exclusively to the health sciences.
* Bachelor's degree in related area and/or equivalent experience/training * Five or more years of directly related experience * Advanced knowledge and ability to apply all relevant Federal, state, and university regulations policies, and federal guidance documents * Advanced knowledge of quantitative and qualitative research design; scientific research concepts and terminology * Demonstrated knowledge of ethical principles related to the ethical conduct of human subjects research * In-depth understanding of the operational requirement related to the management and implementation of the IRB review process * Sufficient professional experience, adequate education, and sound judgment to comprehend, interpret, and analyze publications and reports concerning applicable policies, procedures, and regulations on human subject research issues * Working knowledge of a significant body of scientific and/or medical concepts as well as terminology in order to be able to converse knowledgeably with researchers as well as to analyze and create documents and correspondence * Demonstrated excellent oral (public speaking) and written communication, problem solving and analytical skills. Ability to independently initiate and compose highly technical, comprehensive and concise correspondence to investigators * Ability to quickly identify and synthesize salient features from a fast-paced discussion of highly technical broad-ranging information into a cohesive and well-written stipulations based on this discussion; ability to include individual analysis and research into this process * Excellent organization and interpersonal skills; ability to work with a wide-variety of customers, including faculty members, research staff, students, IRB members and chair persons as well as other office, including Director and Assistant Directors in a consistently professional and service-oriented manner * Ability to work in a high-volume, high-pressure and fast-paced environment * Ability to manage and correctly prioritize a large task list; ability to perform against deadlines with frequent interruptions and competing priorities * Demonstrated self-discipline and independent judgment completing highly complex, broadly defined assignments
* Bachelor's degree in life, physical or social science * Certified IRB Professional; maintaining or achieving status as a Certified IRB Professional * Relevant compliance certification (if applicable) * Minimum five years of work experience in the human subject protection program area or in other research protection programs, clinical research, or management of human research * Detailed working knowledge of a substantial body of regulatory information regarding the protection of the rights and welfare of human research participants (Department of Health & Human Services - DHHS, Office for Human Research Protections - OHRP, and Food & Drug Administration - FDA)
The University of California San Francisco is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic informati
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