Career Center

The Office of Institutional Review Board (IRB) Administration (OIA) is responsible for the oversight, administration, implementation, and management of policies and procedures related to human subject research conducted by UCSD investigators. The OIA supports six Federally mandated human subject research review committees: five Biomedical Institutional Review Boards, and one Social and Behavioral Sciences Institutional Review Board.

As the subject matter/technical expert, this position provides complex analytical and administrative support to the UCSD OIA, Institutional Review Boards (Biomedical and/or Social and Behavioral) and related collaborating University and regulatory (internal and external) offices. In addition to the Committee review procedures, the Principal Analyst will conduct day-to-day high-level, independent reviews of administrative amendments to research protocols, master protocols (from sponsors), Investigator Brochures and related documentation. Responsible for reviewing highly complex materials and determining if changes are warranted to the current documents on file, if the researchers are in compliance with current regulations (based on entity where research is conducted) and if additional information is needed from the researchers.

• Nine (9) years of related experience, education/training, OR a Bachelor’s degree in related area plus five years of related experience/training.

• Advanced knowledge and ability to apply all relevant Federal, state, and university regulations policies, and federal guidance documents. Advanced, 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, Required California law on human experimentation, and university policy regarding human subjects research.

• Advanced knowledge of quantitative and qualitative research design, scientific research concepts and terminology.

• Strong proficiency in public speaking, and writing. Highly effective written, oral communication skills and interpersonal skills to work closely and effectively with faculty members conducting research, committee members, committee chairpersons, senior academic and administrative officers, and federal regulatory and funding agencies. Ability to interact with high level administrators of other universities, academic and community health centers, research sponsors, and federal and state regulatory agencies.

• Proven 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.