As a key element of UC San Diego's overall program of protections for human research subjects, the Office of IRB Administration (OIA) is responsible for the implementation, management and oversight of the review of human subjects research and stem cell research conducted by UCSD investigators. The OIA supports seven research review committees: six federally mandated Institutional Review Boards (IRBs - 5 biomedical, 1 social & behavioral) and a Stem Cell Research Oversight Committee (SCRO). The OIA also manages relationships with a range of external IRBs.
Reporting to the Senior Associate Vice Chancellor for Health Sciences, the Director, IRB Administration has primary responsibility over the Office of IRB Administration. The incumbent is responsible for the development and management of this campus-wide compliance unit and for management of staff who provide support to the review committees. The incumbent is responsible for day-to-day management of the University's review and oversight obligations under applicable federal and state regulations, federal-wide assurances and IRB registrations, as well as agreements with other organizations related to single IRB review.
Establishes objectives and work plans, and delegates assignments to associate directors and analysts. Responsible for managing, preparing, administering, and directing resources. Involved in developing, modifying and executing policies and guidance that affect immediate operation(s) and may also have UCSD-wide effect. Has broad departmental oversight and accountability for policies, guidance and procedures related to human research protections. Serves as the organization authority on IRB compliance issues, and as a liaison between the organization and federal regulators, in addition to representing UCSD and the University of California at national conferences and meetings.
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.
Eleven (11) years of related experience, education and training, OR a Bachelor’s degree in related area plus five (5) years of related experience and training.
Certified IRB Professional or Certified IRB Manager strongly desired.
Managerial experience and proven success in managing compliance review board or committee.
Skill in managing established relationships with regulatory agencies for relevant compliance area.
Ability to apply a complex array of issues, mental flexibility, and creativity to 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.
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.
Demonstrated ability to understand and to formulate both graphical and narrative reports outlining the activity of the IRB.
Experience with exercising strong leadership and supervisory skills in personnel management including experience in providing direction, knowledge of sound management practices, team building techniques, providing recommendations in hiring and performance appraisals; providing guidance and instructions and communicating in an effective, professional and direct manner, and provide disciplinary action as needed.
Master's degree in relevant field of study.
Council for Certification of IRB Professionals (CIP) certification.
Thorough knowledge of UCSD and UC governance, organizational structures, and communication channels; and of UCSD research programs and activities.
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