Assistant Director, Office of IRB Administration - 141553

This position will work a hybrid schedule which includes a combination of working both onsite at Altman Clinical and Translational Research Institute in La Jolla, CA and remote.

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.

• Nine (9) years of relevant experience or a Bachelor's degree plus five (5) years of relevant experience.

• 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.

• 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 UC governance, organizational structures, and communication channels; and of UCSD research programs and activities.

• Employment is subject to a criminal background check.