UCSD Layoff from Career Appointment: Apply by 04/16/20 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.
Special Selection Applicants: Apply by 04/28/20. Eligible Special Selection clients should contact their Disability Counselor for assistance.
Under the direction of the Director/Deputy Director/Associate Director, the Sr. Analyst will independently manage/support the review of the Exempt and Expedite applications, in addition, when needed, may assist in the support of the six Federally mandated human subject research review committees, five Biomedical Institutional Review Boards which review research for the UCSD, and Radys Children Hospital and one Social and Behavioral Sciences Institutional Review Board that reviews research for the entire UCSD campus. The incumbent manages reviews, and other collaborative review efforts such as conflict of interest, radiation safety, biosafety committee, and facilitates and may finalize committee deliberations, when needed. As an alternate member of the Institutional Review Board, may attend assigned IRB meetings, present and summarize findings as appropriate.
The Sr. Analyst provides complex analytical and administrative support to the UCSD Human Research Protections Programs, Institutional Review Boards (Biomedical and/or Social and Behavioral), related collaborating University and external regulatory offices and UC and Non-UC IRB reliance agreements through independent reviews of incoming grants and administrative amendments to research protocols, master protocols (from sponsors), Investigator Brochures, and related documentation. In addition, the analyst will review new information impacting IRBs or related areas and will be involved in recommending process revisions and disseminating information to the VCHS, Campus Principal Investigators (PIs) and study administrative staff. May be asked to audit IRB maintained study records in accordance with HRPP standards and may perform periodic audits of the informed consent process and the approved research at the Investigator's site to ensure that the study is being conducted as required by the IRB.
As the subject matter expert, the Sr. Analyst serves as a resource and is responsible for interpretation of policy and providing training and education to faculty (MDs, PhDs), all Principal Investigators, researchers, study staff, students, human subjects (study participants) and other individuals regarding the protection of human subjects in research compliance guided by Federal, and other regulatory agencies, UC policy and public perception regarding human subjects research across VCHS, Campus. Other duties as assigned.
Bachelor's Degree in related area; and/or equivalent experience/training.
A minimum of three (3+) or more years of IRB/regulatory experience.
Proven self-discipline and sound, independent judgment completing complex assignments. Ability to exercise judgment, tact, and firmness in interaction with faculty, students, staff and IRB members, subjects and others.
Strong knowledge and ability to apply all relevant Federal, state, and university regulations, policies, and federal guidance documents. Thorough knowledge or demonstrated related experiences to comprehend, interpret, and apply complex regulations and legislation regarding the protection of human subjects. These include federal, state and local regulations and policies including DHHS, HHS-OHRP regulation, FDA regulations for the use of investigational drugs, biologics and devices; California law on human experimentation, other compliance agencies or directives, and university policy regarding human subject research.
Thorough knowledge and experience with quantitative and qualitative research design; scientific research concepts and terminology.
Proficiency in public speaking, and writing. Excellent interpersonal, written, and oral communications. Proven ability to compose complex correspondence (high volume, short time-lines) that is accurate, typographically and grammatically correct.
Conflict of Interest: Understanding of stock options, consulting agreements and other corporate documents related to research and analysis of potential conflicts of interest.
Thorough knowledge of informed consent process and ability to conduct audits of the process.
Demonstrated experience in developing training programs and materials to educate different populations to include but not limited to faculty, principal investigators, researchers, study staff, etc.
Expertise in clinical trials and/or behavioral sciences, investigator-initiated stud
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