Assistant Director, Office of IRB Administration - 113649
As a federally-funded institution, UC San Diego Health maintains a marijuana and drug free campus. New employees are subject to drug screening.
#113649 Assistant Director, Office of IRB AdministrationInitial Review Date: Thu 1/20/2022
For the safety and well-being of the entire university community, the University of California requires, with few exceptions, that all students, faculty and staff be vaccinated against the COVID-19 virus and influenza before they will be allowed on campus or in a facility or office. For more information visit: Flu Vaccine Mandate / COVID Vaccine Policy
Special Selection Applicants: Apply by 01/07/22. Eligible Special Selection clients should contact their Disability Counselor for assistance.
Candidates hired into this position may have the ability to work remotely.
As a key element of UCSD'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 Director of the Office of IRB Administration (OIA), the Associate Director of the OIA is responsible for the oversight, administration, implementation, and management of policies and procedures related to human subject research conducted by UCSD investigators. The Associate Director is also responsible for the supervision of staff in support of the six Institutional Review Boards (IRBs) and the one Stem Cell Research Oversight Committee (SCRO).
The Associate Director will ensure program accountability for federally mandated research review committees and compliance with Federal regulations, State laws, and institutional policy applicable to research involving the participation of human subjects. The Associate Director collaborates with the Director in developing and updating campus policies, guidance, and procedures and implementing changes based on regulatory and institutional policies. The Associate Director may 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).
Administers policies and procedures in designated research compliance area conforming to established federal and state agency regulations. Receives assignments in the form of objectives with goals and the process by which to meet goals. Provides direction to staff according to established policies and management guidance. Administers policies that directly affect subordinate staff. Recommends changes to department policies and practices. Identifies risks and responds accordingly. Provides priority setting and work flow analysis.
Bachelor’s degree in related area plus five (5) years of relevant experience, OR nine (9) years of combined relevant experience, education and training.
Managerial experience and proven success in managing compliance review board or committee.
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.
Demonstrated 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.
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.
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.
- Comprehensive knowledge of state and local regulations and policies governing human subject research including: California law on human experimentation and university policy regarding human subject research.
- Council for Certification of IRB Professionals (CIP) certification.
- Thorough knowledge of UCSD and/or UC governance, organizational structures, and communication channels; and of UCSD research programs and activities.
- Employment is subject to a criminal background check.
- Must pass a pre-employment drug test and immunization screening.
- Must be able to work various hours and locations based on business needs.
- Must be available to work evenings when IRB committees meet.
Job offer is contingent on successful engagement in the UC COVID-19 Vaccination program (fully vaccinated with documented proof or approved exception/deferral).
UC San Diego Health Sciences is comprised of our School of Medicine, Skaggs School of Pharmacy and Pharmaceutical Sciences, The Herbert Wertheim School of Public Health and Human Longevity Science, and our Student Health and Well-Being Department. We have long been at the forefront of translational - or "bench-to-bedside" - research, transforming patient care through discovery and innovation leading to new drugs and technologies. Translational research is carried out every day in the hundreds of clinical trials of promising new therapies offered through UC San Diego Health, and in the drive of our researchers and clinician-scientists who are committed to having a significant impact on patient care. We invite you to join our 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
UC San Diego is a smoke and tobacco free environment. Please visit smokefree.ucsd.edu for more information.