Job Summary Under the guidance of the PRMS Manager, the Scientific Review Committee Administrator uses advanced research compliance concepts to interpret highly complex and broad National Cancer Institute (NCI) guidelines, institutional policies and other federal regulations.
Regularly works on highly complex research compliance issues where analysis requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques and evaluation criteria to anticipate and identify problems and develop and implement the appropriate response and/or action.
Serves as a technical expert and advisor to department head, faculty leadership and management. The PRMC is the only NCI-mandated centralized scientific review committee at UCSF, whose records are heavily scrutinized by the NCI, and when problems arise the PRMC Administrator is asked to develop unprecedented solutions unique to the HDFCCC. If the Scientific Review Committee Administrator, which encompasses the Site Commitees and PRMC, is disapproved or conditionally approved, clinical research operations at the UCSF Helen Diller Family Comprehensive Cancer Center (HDFCCC) may be at risk until the PRMS has been re-evaluated and approved. Maintaining full PRMS approval is vital to the operations of the ~25% of UCSF's full-time faculty members and hundreds of staff members working in cancer clinical research -- delays can jeopardize clinical research study funding, enrollment, completion, publications, and contributions of new knowledge to the scientific community.
The Scientific Review Committee Administrator is responsible for all Protocol Review and Monitoring Committee (PRMC) activities. The Scientific Review Committee Administrator has the authority to triage for level of review, return incomplete applications to investigators without committee review, request changes to applications, set agenda, train and assign committee members, interpret member comments, take minutes, issue formal correspondence, review research protocols and certify qualified applications as exempt, select trials for accrual and scientific relevance continuing reviews, initiate and complete continuing reviews, perform administrative review of qualifying protocol amendments, interpret relevant guidelines and policies, make recommendations for new policies and revisions to existing policies, provide guidance to faculty and staff, liaison with Site Committees, revise existing forms and create new forms, request revisions to the Clinical Trial Management System (CTMS), and improve systems.
**Note: This is a hybrid position, it can be remote - TBD
Please note: The compensation ranges listed online for roles not covered by a bargaining unit agreement are very wide, however a job offer will typically fall in the range of 80% - 120% of the established mid-point. An offer will take into consideration the experience of the final candidate AND the current salary level of individuals working at UCSF in a similar role.
For roles covered by a bargaining unit agreement, there will be specific rules about where a new hire would be placed on the range.
The UCSF Helen Diller Family Comprehensive Cancer Center (HDFCCC) is one of an elite network of 52 NCIdesignated Comprehensive Cancer Centers nationally and is significantly supported by a National Cancer Institute (NCI) Cancer Center Support Grant (CCSG). The CCSG mandates an operational PRMS (Protocol Review and Monitoring System), which consists of Site Committees and a centralized Protocol Review and Monitoring Committee (PRMC), and is responsible for ensuring that all cancer-related protocols are reviewed through the central PRMC prior to Institutional Review Board (IRB) approval, and assuring adequate internal oversight of the scientific aspects of all the cancer clinical trials at UCSF. This function complements that of the UCSF IRB, which focuses on the protection of human subjects. Required Qualifications
Bachelor's degree in related area and / or equivalent experience / training
5+ years Related Experience
Prior clinical research experience demonstrating substantial knowledge of regulatory and procedural processes required for trial activation, data safety monitoring concepts, and data collection methods used in clinical trials conduct.
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.
Sufficient professional experience, adequate education, and sound judgment to comprehend, interpret, and analyze applicable regulations, guidance, and institutional policies and procedures. Advanced knowledge and ability to apply all relevant Federal, state, and university regulations, policies, and federal guidance documents, in particular, CCSG guidelines, GCP and ICH E6, and CFR 21 parts 312, 54, 50, 56 and 314.
Advanced knowledge of scientific research concepts, clinical study design and statistical design concepts (quantitative and qualitative), and medical terminology. Working knowledge of advanced cancer biology, biomedical science, and therapies used in complicated cancer cases.
Ability to follow fast-paced discussions of highly technical information and synthesize salient features, and to incorporate independent analysis and research into a cohesive and well-written document.
Demonstrated computer skills including proficiency with the latest version of Microsoft Office Suite, especially Word and Excel, as well as database experience, and proficient use of the Internet as a research tool; experience with clinical trials management systems (CTMS).
Demonstrated diplomacy and political acumen, and the ability to work (and hold your ground) with a wide variety of customers from directors and chair persons to faculty members, committee members, and programmatic, clinical and administrative staff.
Ability to effectively prioritize and re-prioritize as needed, multi-task, work well under pressure, meet deadlines, share relevant information, and work independently.
Demonstrated self-discipline and independent judgment completing highly complex, broadly defined assignments.
Strong proficiency in verbal and written communications.
Bachelor's degree preferably in biomedical, life sciences or social sciences
4+ years work experience in protocol development and/or regulatory affairs (primarily clinical regulatory and IND submissions), and/or regulatory committee management experience, OR an equivalent combination of education and experience.
In-depth knowledge of NCI CCSG reporting mechanisms and guidelines.
Experience running a CCSG-mandated or other scientific or human subjects review committee.
Well-versed in all institutional policies, especially those of the UCSF Institutional Review Board and the HDFCCC.
Experience with OnCore® and iRIS systems.
Statistical experience, either classroom or database use.
Clinical research experience in/familiarity with the academic environment at a large research institution in a university setting.
Familiarity with HDFCCC or other CCSG Data Safety Monitoring Plans.
Demonstrated proficiency with HIPAA regulations and ability to maintain strict standards of confidentiality in dealing with protected health information (PHI).
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.