JOB OVERVIEW The Director of Human Research Protections Program (HRPP) at UCSF is responsible for the overall administration of the program for protecting human participants in research, including the oversight and implementation of, and compliance with, institutional policies and procedures, federal and state statutes and regulations, and ethical and professional standards for the conduct of human research.
The HRPP Director is responsible for the development and management of campus-wide compliance for HRPP and the management of staff who provide support to the Institutional Review Boards (IRB), Quality Improvement Unit (QIU), and Gamete, Embryonic Stem Cell Research Committee (GESCR).
Specific responsibilities include 1) management and supervision of experienced staff that provides administrative and regulatory support to UCSF’s four IRB panels and expedited team, 2) coordination with other divisions and units responsible for implementing other aspects of human research protection programs and initiatives, 3) providing subject matter-specific counsel to HRPP team members, Board members, and investigators, 4) proactively creating or revising policy and corresponding guidance to assure consistency with best practices and evolving external policies such as National Institutes of Health’ (NIH’s) IRB Policy and Common Rule revisions, and 5) advising the Associate Vice Chancellor of Research on matters significantly impacting either the IRB in specific or the broader, institution-wide, network of human subject research
The HRPP Director establishes objectives and work plans, and delegates assignments to subordinate managers. Responsible for managing, preparing, administering, and directing resources. Reviews and approves recommendations for research compliance programs. Involved in developing, modifying and executing policies that affect immediate operation(s) and may also have organization-wide effect. Erroneous decisions or failure to achieve goals results in additional costs and personnel, and serious delays in overall schedules. Has broad departmental oversight and accountability for policies and procedures related to relevant compliance area. Serves as the organization authority on relevant compliance issues, and as a liaison between the organization and federal regulators, in addition to representing the organization and the University of California at national conferences and meetings.
HUMAN RESEARCH PROTECTION PROGRAM UCSF has established a comprehensive Human Research Protection Program (HRPP) to promote the welfare and rights of human research participants, to facilitate excellence in human research and to provide timely and high quality IRB review, education, and monitoring of human subjects research. This program is in compliance with all relevant federal regulations, state laws, University of California, Office of the President (UCOP) and UCSF policies and procedures. The HRPP includes three distinct functional units: the Institutional Review Board (IRBs), and the Quality Improvement Unit (QIU), and Gamete, Embryonic Stem Cell Research Committee (GESCR).
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 * Certified IRB Professional (CIP) or willingness to obtain within six months of hire * Minimum 10 years of work experience in the human subject protection program area or in other research protection programs, clinical research, or management of human research * Five+ years of direct supervisory / management experience. Previous leadership experience combined with a proven and demonstrated track record of leading others and achieving outstanding results * Expertise and experience in supervision and oversight of Internal Review Boards (IRBs) at an Academic Medical Center * Expert knowledge and ability to apply all of the Federal, state, system and university regulations, policies and federal guidance documents * Expert knowledge of quantitative and qualitative research design, scientific research concepts, and terminology * Excellent knowledge of regulatory information regarding the protection of humans in biomedical and social behavioral research * Advanced proficiency in public speaking, and writing * Ability to work collaboratively with the IRB Chairs, Faculty Investigators, Institutional Officials and Office of Research leadership to facilitate on-going development, implementation, and maintenance of the HRPP * Demonstrated self-discipline and independent judgment completing highly complex, broadly defined assignments * Diplomacy and problem-solving skills, motivating and able to productively supervise a diverse group of staff * Ability to resolve conflicts in a timely basis * Ability to interact with faculty, verbally and in writing, with professionalism and decorum * Ability to lead and mentor others
* Advanced degree in a scientific discipline
* Certified IRB Professional (CIP) or willingness to obtain within six months of hire
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 information.