This position is located in the IRB Office of the Minneapolis VA Health Care System. There are over 300 human studies research projects and 400+ protocols being carried out by some 100+ investigators. The incumbent of this position will serve as Human Studies Coordinator for one Institutional Review Boards (IRB). Major Duties: The IRB reviews submitted research projects from a wide variety of disciplines (psychiatry, psychology, internal medicine, cardiology, gastroenterology, infectious diseases, metabolic-endocrine, hematology-oncology, rheumatology, rehab medicine, surgery, neurology, basic science, etc.) and determines whether the protocol is scientifically sound, will likely yield useful information, and that research subjects are adequately protected. Applies knowledge of the theory, principles, methods and instruments used in the design, conduct and reporting of medical research trials to advise the IRB in its review. Serves as an advisor and resource to investigators for designing studies and preparing requests for initial and continuing IRB review. Uses knowledge of regulations and familiarity with the conduct of clinical trials to create and modify IRB forms. Instrumental in establishing electronic protocol submission processes. Receives, disseminates, maintains, and renders interpretations of Food and Drug Administration (FDA), Health and Human Services (HSS), and the Department of Veterans Affairs (V A) policies and regulations pertaining to research studies on human subjects and oversees and supports the activities and composition of the IRB. Educates the investigative community both within and without the MVAHCS on policies and procedures to be followed for conducting research on human subjects, whether conducted by VA 2 personnel on non-VA patients, by non- VA personnel on VA patients, or by VA personnel on VA patients. Reviews rules and regulations which will satisfy requirements for documentation of informed consent and develops standard paragraphs for inclusion in consent forms. Not-to-Exceed 13 months; may be extended for up to 4 years depending on research funding and employee performance. Work Schedule: Full-time, M-F, 8:00am - 4:30pm Telework: Ad Hoc. Will be discussed during interview. Virtual: This is not a virtual position. Position Description/PD#: Health Science Specialist/PD60435T and PD60434T Relocation/Recruitment Incentives: Not authorized Permanent Change of Station (PCS): Not authorized Financial Disclosure Report: Not required
Providing Health Care for Veterans: The Veterans Health Administration is America’s largest integrated health care system, providing care at 1,255 health care facilities, including 170 medical centers and 1,074 outpatient sites of care of varying complexity (VHA outpatient clinics), serving 9 million enrolled Veterans each year.