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Job Summary Note: this position is open to remote work Under the supervision of the Institutional Review Board (IRB) Manager, the Expedited/Exempt/GESCR Coordinator will screen initial review, modification, and continuing review applications for expedited Institutional Review Board (IRB) review, Gamete, Embryo and Stem Cell Research (GESCR) Committee review, or exempt determinations. In many cases, and depending on the individual, the Coordinator will also serve as designated IRB reviewer with authority to approve or require changes to the research. The Coordinator will screen applications for completeness, level of review needed, and compliance with regulations and guidelines; return applications with stipulations if changes are needed; and independently review the submission or when necessary, assign completed applications to IRB chairs and members or GESCR committee chairs or members for formal review.
The Coordinator will be responsible for creating GESCR committee meeting agendas and managing meetings. The individual will analyze and evaluate Committee decisions to ensure compliance with applicable regulations, policies and procedures. If any part of the decision is non-compliant, it is the responsibility for the Coordinator to take corrective action. The Coordinator is the person ultimately responsible for all IRB committee activities related to these studies, such as drafting correspondence to investigators, reviewing investigator responses, assisting with developing and improving systems and procedures for review, educating investigators and members.
The Coordinator writes formal correspondence to the investigator based on both the Committee's decisions and his or her own analysis of the protocol, reviews the investigator's response, and determines the next steps (either soliciting more information from the investigator, completing the review, or forwarding the response to the Committee members for further consideration). At each step the Coordinator must evaluate researchers' and members' concerns and responses and advise them of federal, state, and local regulations and guidance that limit the committee's decisions.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 related area and/or equivalent experience/training * Minimum 5 years of work experience in the human subject protection program area or in a combination of relevant work experience in other research protection programs, social and behavioral research, clinical research or in management of human research * Demonstrated computer skills such as a word-processing, use and development of spreadsheets, database use, and use of Internet * Advanced knowledge and ability to apply all relevant Federal, state, and university regulations policies, and federal guidance documents * Advanced knowledge of regulatory information regarding the protection of humans in biomedical and behavioral research, including Health Insurance Portability and Accountability Act (HIPAA) * Demonstrated independent judgment/sound judgment to comprehend, interpret, and analyze publications and reports concerning applicable policies, procedures and regulations and California laws * Working knowledge of a significant body of scientific and medical concepts and terminology. Must have interest and facility with dealing in science. Ability to investigate and analyze scientific topics on the internet and in scientific journals * Demonstrated strong verbal and written communication skills * 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 document, based on this discussion and including individual analysis and research * Ability to work with a wide variety of customers, including faculty members, committee members and chair-persons, committee staff, senior academic administrators, federal regulatory officials and funding agency auditors * Ability to work in a high-volume, fast-paced environment. Must multi-task, be organized, able to re-prioritize tasks as needed, and be flexiblePreferred Qualifications * Bachelor's degree, preferably in life, physical or social science * Certified IRB Professional (CIP) * Working knowledge of state and federal guidelines related to embryonic stem cell and/or other stem cell research (CIRM, NIH, etc.) * Working knowledge of medical anthropology and social and behavioral science and research * Maintaining or achieving designation 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.