The Human Research Protections Program (HRPP) is responsible for the oversight, administration, implementation, and management of policies and procedures related to human subject research and stem cell research conducted by UC San Diego Health Sciences investigators. The HRPP supports six Federally mandated human subject research review committees: five Biomedical Institutional Review Boards, one Social and Behavioral Sciences Institutional Review Board; and one Stem Cell Research Oversight Committee. The HRPP also manages relationships with a range of external IRBs.
Reporting to the Director of the Human Research Protections Program (HRPP), the Associate Director of the Biomedical Institutional Review Boards is responsible for the oversight, administration, implementation, and management of policies and procedures related to human subject research conducted by UCSD biomedical and clinical investigators. The Associate Director (AD) is also responsible for the supervision of staff in support of the five Biomedical Institutional Review Boards (IRB), and the one Stem Cell Research Oversight (SCRO) Committee.
The AD will ensure program accountability for federally mandated research review committees and compliance with Federal regulations, State laws, and institutional policy applicable to biomedical and clinical research involving the participation of human subjects. Collaborates with the Director in developing and updating campus policies, guidance, and procedures and implementing changes based on regulatory and institutional policies. The AD will have contact with federal agencies such as the Department of Health and Human Services-Office for Human Research Protections (HHS- OHRP) and the Food and Drug Administration (FDA).
The AD role requires comprehensive knowledge of federal, state, and local regulations regarding research with human subjects and stem cells. The AD will be the primary resource for the biomedical IRB staff and committee members, and the faculty members engaged in biomedical and clinical research. In addition, the AD must possess a working knowledge of a significant body of scientific and medical concepts and terminology to properly review research proposals, request necessary additional information from researchers as necessary, such as prior to review of adverse events and unanticipated problems, to evaluate actions taken by investigators in response to committee requests, and to ensure compliance with the approved protocols.
The AD administers IRB policies and procedures to assure compliance with federal and state regulations and institutional policies. Receives assignments in the form of objectives with goals and must review and revise the process to meet such goals. Provides direction to staff according to established policies and management guidance. Administers policies that directly affect IRB staff. Recommends changes to unit policies and practices. Identifies risks and responds accordingly. Provides priority setting and work flow analysis. Recommends and implements policies and procedures based on federal and state agency regulations for relevant compliance area.
Provides leadership over compliance committees. Manages all issues related to relevant compliance area. Serves as a liaison between the organization and federal regulators, in addition to representing the organization at regional conferences and meetings. Receives assignments in the form of objectives and determines how to use resources to meet schedules and goals. Reviews and approves recommendations for Research Compliance programs for COI. Provides guidance to subordinates to achieve goals in accordance with established policies. Erroneous decisions or failure to achieve goals results in additional costs and personnel, and serious delays in overall schedules.
A Bachelor's Degree in related area; and/or equivalent combination of experience and training.
Seven (7+) or more years of relevant experience in human subjects research, ideally in an academic medicine setting.
Demonstrated managerial experience and proven success in managing compliance review board or committee.
Demonstrated ability to understand and to formulate both graphical and narrative reports outlining the activity of the IRB.
Proven ability to apply a complex array of issues, mental flexibility, and creativity to relevant compliance area. Skill in managing established relationships with regulatory agencies for relevant compliance area.
Comprehensive knowledge of federal, state, and local regulations and policies governing human subject research including: the HHS-OHRP regulations, FDA regulations for the use of investigational drugs, biologics and devices, California law on human experimentation, and university policy regarding human subjects research.
Proven ability to recruit, train and supervise program staff in the interpretation and implementation of complex regulations. Excellent supervisory skills and sound judgment necessary to organize workload, delegate responsibilities, evaluate and perform corrective action/discipline staff.
Strong ability to independently and accurately represent UCSD policies regarding human subjects research in interactions with high level administrators of other universities, academic and community health centers, research sponsors, and federal and state regulatory agencies.
Working knowledge of a significant body of scientific and medical concepts and terminology to properly review research protocols, request necessary additional information from researchers prior to review of unanticipated problems, adverse events or possible violations of human subject protection policy, to evaluate actions taken by investigators in response to committee requests, and to ensure compliance with the approved protocols.
Highly effective written, oral communication skills, interpersonal skills and sound judgment necessary to work closely and effectively with faculty members conducting research, committee members, committee chairpersons, senior academic and administrative officers, and federal regulators.
A Master's Degree in related area.
Certified IRB Professional or Certified IRB Manager strongly desired.
Professional certification preferred for relevant compliance area (if applicable).
Relevant experience in an Academic Medical Center.
Employment is subject to a criminal background check.
Must be available to work evenings when IRB committees meet.
UC San Diego Health is the only academic health system in the San Diego region, providing leading-edge care in patient care, biomedical research, education, and community service. Our facilities include two university hospitals, a National Cancer Institute-designated Comprehensive Cancer Center, Shiley Eye Institute, Sulpizio Cardiovascular Center, and several outpatient clinics. UC San Diego Medical Center in Hillcrest is a designated Level I Trauma Center and has the only Burn Center in the county. We invite you to join our dynamic team!
Applications/Resumes are accepted for current job openings only. For full consideration on any job, applications must be received prior to the initial closing date. If a job has an extended deadline, applications/resumes will be considered during the extension period; however, a job may be filled before the extended date is reached.
UC San Diego Health is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, age, protected veteran status, gender identity or sexual orientation. For the complete University of California nondiscrimination and affirmative action policy see: http://www-hr.ucsd.edu/saa/nondiscr.html
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