Human Research Protections Program (HRPP) IRB Senior Analyst
Filing Deadline: Fri 1/31/2020
The Human Research Protections Program (HRPP) is responsible for the oversight, administration, implementation, and management of policies and procedures related to human subject research conducted by UCSD investigators. The HRPP supports six Federally mandated human subject research review committees: five Biomedical Institutional Review Boards, and one Social and Behavioral Sciences Institutional Review Board.
Under the direction of the Director/Deputy Director/Associate Director, the IRB Senior Analyst will independently manages/supports 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, four Biomedical Institutional Review Boards which review research for the UCSD, and Radys Children Hospital and a Social and Behavioral Sciences Institutional Review Board that reviews research for the entire UCSD campus. The IRB Senior Analyst 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 IRB Senior 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. The Sr. Analyst 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 IRB Senior 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.
Uses skills as a seasoned, experienced research compliance professional with a full understanding of industry practices and organization policies/procedures to apply federal, state, and university regulations, policies, and guidelines, and promote best practices. Interacts frequently with investigators, persons in other organizational departments, and occasionally persons outside the University. Interactions require the use of tact and independent judgment, knowledge of standards and best practices, and counseling to resolve a wide range of research compliance issues. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Errors or omissions may ultimately place research participant at undo risk and/or compromise the institution's assurance of regulatory compliance with the federal government.
Bachelor's degree in related area and/or equivalent experience/training.
Demonstrated self-discipline and sound, independent judgment completing complex assignments. Demonstrated ability to exercise judgment, tact, and firmness in interaction with faculty, students, staff and IRB members, subjects and others.
Thorough 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.
Demonstrated proficiency in public speaking, and writing. Demonstrated 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.
Demonstrated ability to work as a team member, learn quickly and independently, but also be able to take direction well. Demonstrated ability to set priorities and accomplish tasks in an environment with frequently interruptions and constantly changing priorities. Absolute reliability in matter of confidentiality.
Expertise in clinical trials and/or behavioral sciences, investigator-initiated studies, and grant-supported research or related areas. Knowledge of the academic research and medical/scientific terminology and demonstrated ability to comprehend the research process and the various components.
Demonstrated ability to conduct analysis of administrative procedures and effectively recommend appropriate monitoring mechanism. Demonstrated ability to make decisions. Strong administrative and organization skills.
Thorough knowledge of a significant body of scientific and medical concepts and terminology to properly review research proposals, request necessary additional information from researchers prior to review of adverse events or possible violations of human subject protection policy, to evaluate actions taken by investigators in response to committee requests, and to audit and ensure compliance with the approved protocols.
Thorough knowledge and experience to conduct delicate and sometimes adversarial negotiations with faculty researchers to implement decisions of IRB Committees and Chair's designee.
Proven experience developing educational programs with the ability to make effective presentations and deliver to a diverse audience.
Certified IRB Professional or Certified IRB Manager.
Employment is subject to a criminal background check.
Ability to attend meetings after usual working hours (currently evening IRB meetings are scheduled approximately 5-10 p.m. Thursdays, and the analyst would be required to attend one meeting per month), occasionally two per month.
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