Job Description

Payroll Title:
RSCH CMPLNC ANL 2
Department:
CNTR HUMAN DEVELOPMENT
Hiring Salary Range
$48,900 to $70,000 / Year
Worksite:
Campus
Appointment Type:
Career
Appointment Percent:
100%
Union:
Uncovered
Total Openings:
1
Work Schedule:
8 hrs/day, Mon - Fri

#113185 Research Compliance Analyst 2 or 3

Filing Deadline: Wed 12/8/2021

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

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.

DESCRIPTION

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 sites, and 6) tracking and reporting withdrawals, unexpected problems, and protocol violations.

The incumbent will also perform project management duties by providing support on a broad range of issues by exercising sound judgment, initiative, and resourcefulness. Ensures the smooth day-to-day operations of the HCAC. Gathers, analyzes, and interprets data needed to set priorities for the Admin Core. Researches issues and problems, drafts materials, and provides recommendations.

QUALIFICATIONS

Qualifications for Research Compliance Analyst 2.

  • Working experience with US Department of Health and Human Services regulations, NIH policies and procedures, and Good Clinical Practice guidelines for the conduct of research.

  • Knowledge of relevant Federal and State regulations, and policies. Ability to stay up to date on relevant regulatory issues, changes, and revisions to policy that are required for current job. General understanding of IRB research plans and creating informed assent/consent documents that comply with HRPP policies and procedures, DHHS regulations, and sponsor requirements.

  • Experience coordinating aspects of a single IRB for a multi-site research study.

  • Ability to understand complex scientific and research concepts. Experience in expressing such content into succinct copy for reports, correspondence, communications, and IRB documents.

Qualifications for Research Compliance Analyst 3.

  • In-depth experience working with US Department of Health and Human Services regulations, NIH policies and procedures, and Good Clinical Practice guidelines for the conduct of research with a strong emphasis in human subject protections.

  • Strong experience working on single IRBs for a research study using a common protocol across multiple study sites. Extensive experience writing IRB research plans and creating informed assent/consent documents that comply with HRPP policies and procedures, DHHS regulations, and sponsor requirements.

  • Thorough knowledge and ability to apply all relevant Federal, state, and university regulations, policies, and federal guidance documents. Ability to stay up to date on relevant regulatory issues, changes, and revisions to policy that are required for current job.

  • Thorough knowledge and experience with quantitative and qualitative research design; scientific research concepts and terminology. Working knowledge of medical and scientific terminology. Ability to understand complex scientific and research concepts. Experience in expressing such content into succinct copy for reports, correspondence, communications, and IRB documents.

  • Demonstrated proficiency in public speaking, and writing. Excellent oral and written communication skills to effectively communicate with diverse audiences including HBCD leadership, consortium investigators, research staff, and federal collaborators.

  • Demonstrated experience in management of large, complex, multi-site, longitudinal, pediatric research studies.

  • Experience managing all aspects of a single IRB for a multi-site research study.

  • Experience developing, maintaining, and executing project management plan to coordinate complex, high impact projects.

  • Understanding of stock options, consulting agreements and other corporate documents related to research and analysis of potential conflicts of interest preferred.

Overall qualifications:

  • Degree in behavioral neuroscience or a related field, or equivalent experience / training.

  • Excellent interpersonal skills to interact with diverse personnel at all levels of various organizations (internal and external), exercising tact, mature judgment, diplomacy, and flexibility to promote positive working relationships and job effectiveness.

  • Superior time management and decision-making skills. Ability to use independent judgment to quickly set priorities and to solve problems. Demonstrated ability to respond effectively to unexpected events.

  • Proficiency with computers with proven ability to perform all commonly applicable functions in word processing and spreadsheet software. Experience with online collaboration and survey tools such as Confluence and Qualtrics to facilitate study management for research study. Ability and willingness to learn new software as needed.

  • Experience maintaining files and keeping records. Ability to maintain confidentiality.

  • Relevant compliance certification (if applicable) preferred.

  • Working knowledge of UC San Diego Human Research Protections Program (HRPP) policies and procedures preferred.

  • Experience in coordinating large and complex multi-site pediatric research studies preferred.

SPECIAL CONDITIONS

  • Occasional evenings and weekends may be required.

  • Job offer is contingent upon satisfactory clearance based on Background Check results.

  • 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.


Job offer is contingent on successful engagement in the UC COVID-19 Vaccination program (fully vaccinated with documented proof or approved exception/deferral).

The University of California 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.

Application Instructions

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