Job Code and Payroll Title
006231 RSCH CMPLNC ANL 4
TEP is recruiting for a temporary Research Compliance Analyst 4 through January 2022.
The Institutional Review Board (IRB) Analyst supports the UCSF Office of Ethics and Compliance and the UCSF mission to advance health worldwide. Will do this by working closely with physicians, research scientists and study personnel from UCSF and its affiliates to administer, coordinate and facilitate the review and approval of complex biomedical research studies that are reviewed by a panel of experts at convened "full committee" meetings of the IRB. The Analyst also facilitates the review and approval of minimal risk research studies. Must be able to perform a thoughtful initial review of these scientific protocols, identify problematic areas that may require additional clarification, and determine which IRB members have the specific expertise to be able to conduct a review of the science. In addition, must be able to clearly convey committee members' concerns to the scientists proposing the research, communicate researchers' responses back to the IRB committee members, carefully summarize the deliberations of the committee in the meeting minutes, and ensure that the research activities are fully compliant with the federal regulations governing human subjects research. This entails an advanced understanding of the study protocol and as well as a thorough familiarity with federal and state regulations related to the human subjects in research. Responsibilities include the following:
- Collaboration with the five IRB committees responsible for reviewing and approving research involving the participation of human subjects.
- Ensuring that the research protocols comply with all relevant federal and State regulations, University policies, and HRPP procedures.
- Screening and editing new full committee and expedited studies submitted to the IRB, and providing extensive feedback and guidance to research team members and IRB members. The Coordinator also screens and edits modifications and continuing reviews.
- Participating in deliberations during IRB meetings as an ex officio, nonscientist voting member, providing IRB chairs, vice chairs and members with regulatory, ethical and policy guidance as well as specific information about individual research studies.
- Composing a large volume of in-depth analytical correspondence based on the IRB deliberations, records meeting minutes, and issuing approval notices based on conditions imposed by the IRB. Advising faculty and staff on how their projects, programs and applications can best comply with ethical, regulatory and procedural requirements for the conduct of human research.Training research staff in the preparation of applications, consent forms and recruitment materials, and being available for ongoing consultation and in-person presentations.Reviewing, analyzing and implementing UCSF policies and guidance for the protection of the safety and welfare of human research participants and preparing and implementing procedures as needed.
RSCH CMPLNC ANL 4Employee Class
Temporary EmploymentAppointment End Date
8 Hours Shift
99 - Policy-Covered (No Bargaining Unit) Job Category
Temporary Employment Required Qualifications
- Bachelor's degree in life, physical or social science or related area and / or equivalent experience / training.
- Advanced knowledge of quantitative and qualitative research design; scientific research concepts and terminology.
- Five (5) or more years of directly related work experience.
- Demonstrated knowledge of ethical principles related to the ethical conduct of human subjects research.
- In-depth understanding of the operational requirement related to the management and implementation of the IRB review process.
- 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.
- 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.
- 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.
- 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 stipulations based on this discussion; ability to include individual analysis and research into this process.
- Excellent organization and interpersonal skills; ability to work with a wide-variety of customers, including faculty members, research staff, students, IRB members and chair persons 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 (CIP)
- Minimum 5 years work experience in the human subject protection program area or in other research protection programs, clinical research, or management of human research.
- 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).
- Maintaining or achieving status as a Certified IRB Professional.
Temporary EmploymentDepartment Name
Temporary Employment ProgramEqual Employment Opportunity
The University of California San Francisco is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.Department Description
UCSF's Temporary Employment Program (TEP) recruits and hires temporary employees for immediate clerical and technical support services to UCSF Departments and various off-campus locations. UCSF departments deploy temporary employees to work on special projects, fill in for regular employees who are on vacation or leave, or to temporarily fill a vacant position during recruitment. Frequently temporary employees become successful candidates for career and limited appointment positions.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.Location
Remote / Telecommute
This job has expired.