Job posting will remain open until position is filled.
UCSD Layoff from Career Appointment: Apply by 11/29/21 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.
Special Selection Applicants: Apply by 12/8/21. Eligible Special Selection clients should contact their Disability Counselor for assistance.
Position will be filled either as a Research Compliance Analyst 2 or RCA 3. The title/pay level of this position will be based on the qualifications and experience of the candidate identified for hire.
The HEALthy Brain and Child Development (HBCD) Study is a large-scale longitudinal study of the brain, cognitive, and emotional development that will follow mothers and their children from before birth through the first decade of life. The project will involve over 7,000 families at 25 sites across the United States and the close partnership of over 500 investigators, research staff, consultants, external board members, and federal collaborators from a dozen NIH institutes and offices. The HBCD Consortium seeks to better understand which harmful and protective environments exert the greatest impact on child development. Knowledge gained from this research will help to improve the health and development of children across the nation.
Research Compliance Analyst 2
The IRB (sIRB) Study Coordinator will serve as a member of the HBCD Consortium Administrative Core (HCAC) ensuring all aspects of IRB compliance for this nationwide, multi-site study. Serves as a point of contact to answer questions and provide general advice on IRB matters for all consortium members. Researches general topics, develops a historical framework of issues, consults with HRPP staff, and makes recommendations to senior leadership as needed. Reviews and prepares research protocols and related documents for submission to the UC San Diego Human Research Protections Program (HRPP). Interacts with site PIs to ensure site-specific local context changes are made to forms and ensures research personnel is using consistent, correct, and up-to-date forms across all sites. Prepares, reviews and submits protocol amendments to the HRPP, including but not limited to modifications to the research plan and informed consent documents. Prepares and submits protocol deviations to the HRPP, proposing and implementing remedies and retraining as appropriate. Reviews and prepares annual continuing review documents to ensure alignment with compliance requirements.
The incumbent will also serve as one of the project coordinators for the HBCD Study by exercising sound judgment, initiative, and resourcefulness. Coordinates the day-to-day activities of the HCAC as needed. Gathers, analyzes, and interprets data needed to set priorities for the Admin Core. Utilizing knowledge of the research project, drafts and disseminates communications on behalf of the HCAC Directors. Reviews and provides responses on a high volume of incoming inquiries and requests relating to the programs from consortium members, federal collaborators, research participants, the scientific community, the media, and the public. Routes questions to the appropriate consortium member, or elevates complex, confidential, and sensitive matters to senior leadership for resolution when needed. Attends weekly conference calls and annual in-person training meetings with RAs across all study sites.
Research Compliance Analyst 3
The single IRB (sIRB) Manager serves as a member of the HBCD Consortium Administrative Core (HCAC) for this nationwide, multi-site study. Acts as the liaison between the University of California San Diego IRB (the reviewing IRB for the HBCD Study), investigators and IRB personnel at all study sites, and NIH collaborators. Serves as a primary point of contact and provides advice on IRB matters for all consortium members. Researches moderately complex topics, develops a historical framework of issues, consults with HRPP staff, and makes recommendations to senior leadership. The incumbent will be responsible for managing IRB compliance for the study including 1) preparing, reviewing, amending, and submitting research plans, consent forms, and related compliance documents for IRB review and approval, 2) Reviewing all new protocol elements or sub-studies for risk, privacy and other IRB implications, 3) maintaining complete and accurate study files, 4) acting as a resource to HCAC leadership, consortium investigators, and research staff for interpretation and execution of complex research regulations, policies, and procedures, 5) monitoring IRB protocol compliance by RAs across all study site
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