IRB Analyst 4 â Reliance Program (remote optional)
Location: San Francisco, California
Type: Full Time
Internal Number: 117742176
Job Summary *This position is open to remote work* The Institutional Review Board Analyst (IRB Analyst) composes and revises operating procedures, policies, and guidelines. Th IRB Analyst develops materials and conducts training for, and works alongside, the UCSF Human Research Protection Program (HRPP) reliance team, which conducts administrative and local context review of research where an external IRB is serving as the IRB of Record in lieu of the UCSF IRB or where the UCSF IRB is serving as the IRB of Record for an external site or investigator as allowed under regulation and UCSF policies and procedures.
The IRB Analyst uses advanced research compliance concepts, logical-thinking, advanced problem-solving and deductive skills to interpret highly complex and broad human research protections, National Institutes of Health (NIH), Food & Drug Administration (FDA), and other federal and state regulations, policies, and guidelines. The incumbent regularly works on highly complex human research compliance issues in performing administrative and local context reviews of research and advising the HRPP reliance team on same where analysis requires an in-depth evaluation of variable and numerous factors. The incumbent exercises judgment in selecting methods, techniques and evaluation criteria for the appropriate level of review and instructing other members of the reliance team on same, as required by regulation and policy, and anticipates and identifies problems and develops and implements the appropriate response and / or action. Serves as a technical/subject expert and adviser to department head.
The Human Research Protection Program (HRPP) of UCSF in partnership with the research community, is responsible for ensuring the ethical and equitable treatment of all human research subjects in studies being conducted at UCSF and its affiliates and partners and/or being conducted by UCSF faculty regardless of site of activity. The HRPP oversees the Institutional Review Board (IRB) office and is also responsible for ensuring compliance with federal regulations, state laws and University polices as well as national standards for research involving human participants. Required Qualifications
Bachelor's degree in in life science, physical science or social science or related area and / or equivalent experience / training
Five (5) or more years of work experience developing and delivering IRB-related technical documentation and trainings or related experience
Five (5) or more years of work experience in the human subject protection program area, IRB reliances, or in other research protection programs, clinical research, or management of human research
Prior work experience initiating and composing technical, comprehensive, policies, procedures, training materials and guidance
Prior work experience developing and delivering in-person or live virtual training
Detailed working knowledge of a substantial body of regulatory information regarding the protection of the rights and welfare of human research participants (DHHS, OHRP, and FDA)
In-depth understanding of the operational requirement related to the management and implementation of the IRB review process
Advanced knowledge and ability to apply all relevant Federal, state, and university regulations policies, and federal guidance documents
Advanced knowledge of quantitative and qualitative research design, scientific research concepts and terminology
Demonstrated self-discipline and independent judgment completing highly complex, broadly defined assignments
Demonstrated knowledge of ethical principles related to the ethical conduct of human subjects research
Working knowledge of a significant body of scientific and/or medical concepts as well as terminology in order to be able to converse knowledgeably with researchers as well as to analyze and create documents and correspondence
Sufficient professional experience, adequate education, and sound judgment to comprehend, interpret, and analyze publications and reports concerning applicable policies, procedures, and regulations on human subject research issues
Ability to quickly identify and synthesize salient features from a fast-paced discussion of highly technical broad-ranging information into a cohesive and well-written summary based on this discussion; ability to include individual analysis and research into this process
Demonstrated excellent oral (public speaking) and written communication, problem solving and analytical skills. Ability to independently initiate and compose highly technical, comprehensive and concise correspondence to investigators
Excellent organization and interpersonal skills; ability to work with a wide-variety of customers, including faculty members, research staff, students, IRB members and chairpersons as well as other office, including Director and Assistant Directors in a consistently professional and service-oriented manner
Ability to work in a high-volume, high-pressure and fast-paced environment
Ability to manage and correctly prioritize a large task list; ability to perform against deadlines with frequent interruptions and competing priorities
Ability to maintain strict standards of confidentiality in dealing with protected information
Demonstrated proficiency with the most current version of applications in the Microsoft Office Suite, including advanced skills in Word and Excel
Certified IRB Professional
Maintaining or achieving status as a Certified IRB Professional
About UCSF The University of California, San Francisco (UCSF) is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care. It is the only campus in the 10-campus UC system dedicated exclusively to the health sciences. We bring together the world's leading experts in nearly every area of health. We are home to five Nobel laureates who have advanced the understanding of cancer, neurodegenerative diseases, aging and stem cells.Pride Values UCSF is a diverse community made of people with many skills and talents. We seek candidates whose work experience or community service has prepared them to contribute to our commitment to professionalism, respect, integrity, diversity and excellence - also known as our PRIDE values.
In addition to our PRIDE values, UCSF is committed to equity - both in how we deliver care as well as our workforce. We are committed to building a broadly diverse community, nurturing a culture that is welcoming and supportive, and engaging diverse ideas for the provision of culturally competent education, discovery, and patient care. Additional information about UCSF is available at diversity.ucsf.edu
Join us to find a rewarding career contributing to improving healthcare worldwide.