As the Manager of IRB Operations, you will work under the direction of the Executive Director of Research Compliance and QI (Director) to ensure and promote compliance with regulations governing the protection of human subjects in research. Key to meeting this goal is the execution and management of high quality, effective and efficient Institutional Review Board (IRB) operations and ensuring integration with the institutional Human Research Protection Program (HRPP).
As Manager, you will be responsible for maintaining a current understanding and awareness of regulations, policies and trends in clinical research to be able to advise the Director regarding required programmatic changes. The Manager collaborates with other departments (including Legal Affairs, Risk Management, Health Information, Corporate Compliance, Marketing and Public Relations, EIS, and various clinical departments) and executive management throughout the institution, as necessary, to support the HRPP.
Specific duties and responsibilities:
Manage the day-to-day administrative operations of the IRB submission, review and approval process. Ensure compliance, high quality review, and efficiency in IRB operations.
Manage and supervise the following positions: 2 Senior Research Compliance Analysts and 8 IRB Analysts. In consultation with the Director, make decisions related to the hiring, firing, and discipline of staff. Ensure effective on-boarding, training, ongoing supervision, adherence to departmental performance standards and professional development for all team members.
Manage all aspects of IRB committee meetings, including ensuring adequate meeting attendance to conduct meetings, reviewer assignments, staff support, technical support, agenda creation, meeting minutes, and supporting the IRB chair in managing the meeting.
Manage the IRB reliance program, including tracking of reliance agreements and procedures for reliance through various organizations and mechanisms, including review and oversight of collaborative research with Cedars-Sinai affiliates. Oversee the continued expansion and streamlining of the reliance processes.
Work with the Quality Improvement and Education team to help develop policies, procedures, work instructions, tools, templates and guidance to support IRB analysts, IRB members and the research community with respect to the IRB submission, review and approval process.
Provide regulatory and administrative expertise and guidance to IRB staff, IRB members/chairs and the research community to support them in their respective roles.
Together with the Quality Improvement and Education team, maintain relationships with departmental research leadership and ancillary review departments to assess their needs and facilitate ongoing communication to support the submission, review, approval and conduct of research with human subjects. Represent the IRB in various meetings with both internal and external colleagues.
Collaborate with the Compliance and Post-Approval Monitoring and Quality Improvement and Education teams to identify focus areas for monitoring, systems improvements, policy/procedure development/revision and education to ensure a high quality, compliant, and efficient HRPP.
Assist the Director in maintaining full AAHRPP accreditation for the institutional human research protection program. Help draft AAHRPP accreditation renewal applications, annual reports, training materials for site visits, and responses to site visits.
Provide domain expertise and feedback in the oversight and ongoing enhancement of the IRB on-line system. Specific areas of focus include: the IRB application form, IRB meeting management, and workflow/functionality related to the IRB submission, review and approval process .
Conduct special projects as assigned by the Director.
Providing healthcare for more than 100 years, Cedars-Sinai has evolved into one of the most dynamic and highly renowned medical centers in the world. Along with caring for patients, Cedars-Sinai is a hub for biomedical research and a training center for future physicians and other healthcare professionals. This attracts exceptional talent to Cedars-Sinai, including world-renowned physician-scientists who seek a place where they can both conduct research and see patients--the ideal formula for discovery and its translation into cures. Our patients benefit from access to doctors at the top of their fields, and our researchers have an ideal community in which to study the impact of healthcare challenges, and reflect that knowledge in their research. The greater Los Angeles area in which Cedars-Sinai resides possesses unparalleled cultural and ethnic diversity which offers outstanding opportunities for translational and clinical research... and a dynamic environment for medical education.Although community based, Cedars-Sinai is a major teaching hospital affiliated with the David Geffen School of Medicine at the University of California, Los Angeles (UCLA). Cedars-Sinai has highly competitive graduate medical education programs in more than 50 specialty and subspecialty areas, a graduate program in biomedical sciences and translational medicine, a clinical scholars program directed towards junior physicians with aspirations to become clinical scientists, and post graduate training opportunities.There are more than 250 full-time faculty members at Cedars-Sinai. The voluntary medical staff, comprised of more than 2,200 specialty board-certified or board-qualified physicians, represent all of the specialties and subspecialties and collaborate with full-time medical staff in the teaching responsibilities of the graduate medical education programs.