Detroit, MI, 48208, USA
11 days ago
Institutional Review Board Analyst, Division of Research & Innovation
Institutional Review Board Analyst, Division of Research & Innovation Wayne State University is searching for an experiencedInstitutional Review Board Analyst, Division of Research & Innovationat its Detroit campus location. Wayne State is a premier, public, urban research university located in the heart of Detroit, Michigan where students from all backgrounds are offered a rich, high-quality education. Our deep-rooted commitment to excellence, collaboration, integrity, diversity and inclusion creates exceptional educational opportunities which prepare students for success in a global society. Position Purpose: The Institutional Review Board (IRB) Analyst will review all proposed research project submissions to the Institutional Review Board, including Protocol/Proposal documents, and administrative approvals for consistency with federal guidelines and institutional requirements. Provide real-time and functional analysis and assist in management activities and procedures of the IRB’s electronic platforms and electronic submission procedures. The position will report to the Associate Director, Institutional Review Board. Essential Job Functions: Manage Institutional Review Board (IRB) continuation/renewal and status check in processes. Pre-Review full board and expedited continuation submissions in preparation for Institutional Review Board Reviewer and committee determination/approval. Review continuation submissions to determine appropriate review type, provide considerations for Institutional Review Board reviewers to determine if the research meet the criteria for renewal. Perform Institutional Review Board regulatory review of documents (i.e., minutes, unanticipated problem reports, Institutional Review Board files) for quality assurance. Provide regulatory knowledge and support for both WSU and the affiliate institutions regarding the protection of human research participants. Assist investigators and their staff with submission to the WSU Institutional Review Board, including the provision of a thorough pre-review of renewals and submissions. Assist and provide support with regulatory audits and inspections including accreditation visitors and federal inspectors. Review all proposed research project submissions to the Institutional Review Board, including Protocol/Proposal documents, and ensure administrative approvals are consistent with federal guidelines and institutional requirements. Organize the intake of initial submissions, unanticipated problem reports, and other submissions. Contact Principal Investigators and/or research personnel regarding missing elements that must be provided before the submission can be accepted by the IRB Administration. Authorize external IRB submissions key. Research personnel deletion and additions. Direct submitters to the appropriate submission process in order for submissions to be completed and ultimately reviewed. Verify that appropriate documentation is obtained before acceptance and review procedures are conducted. Assist in conducting interviews and candidate selection of IRB Office student assistants. Monitor student assistants assigned and completed tasks. Coordinate the daily activities of the Office for the Protection of Research Subject (OPRS) and Institutional Review Board (IRB). This includes coordinating and conducting pre-checks of initial submission to confirm that all elements are there for the initial review to be conducted or returned if the pre-check items are missing. Determine and compile meeting agendas to meet distribution deadline. Disseminate meeting items and packets. Assure that IRB members have all the requisite information to review human subject research and provide the necessary documents that will enable them to perform their review tasks. Assist the Associate Director with preparing and confirming schedules for all the full board IRB committees for each fiscal year. Act as an intercessory between the board, research participants, the research community, sponsors, and other involved institutions; and appropriately addresses issues, including complaints. Work closely with the affiliates (i.e., Clinical Trial Office, Veterans Administration Research Office, Detroit Medical Center) to ensure effective communications with the WSU Institutional Review Board and provide affiliate reports. Guide research staff and investigators in compiling the correct and complete documents for submission to the IRB. Provide training and serve as the information resource for the Program Project Assistant position that helps with managing eProtocol inquiries on a daily basis and unanticipated problem report data base management. Contribute to the revisions and implementation of IRB forms, policies, and procedures, as well as other resources for the research community. Other duties as assigned. This description is intended to indicate the kinds of tasks and levels of work difficulty that will be required of positions that will be given this title and shall not be construed as declaring what the specific duties and responsibilities of any particular position shall be. It is not intended to limit or in any way modify the right of any supervisor to assign, direct and control the work of employees under their supervision. The use of a particular expression or illustration describing duties shall not be held to exclude other duties not mentioned that are of similar kind or level of difficulty. Doc ID: 35078ac3adb0eed686abfd9301ae37d5e5a9547e Minimum Qualifications: Education: Graduation from an accredited college or university or equivalent experience in the field of research compliance or research regulatory support. Years of Experience Required: Minimum of 2 - 5 years’ experience with Institutional Review Boards/ethics board procedures, research submission methods and procedures. ADDITIONAL COMMENTS: Advanced written, oral, and interpersonal communication skills. Strong prioritization, organizational, and analytical skills. In depth knowledge of federal, state, and local regulations regarding the protection of humans in research. Ability to negotiate/mediate with a variety of professionals including scientists and physician investigators. Strong customer service skills and ability to work independently in a deadline-driven environment. Strong understanding of all the technical terminology involved in the work in order to decide which research projects and protocols need to be discussed. This description is intended to indicate the kinds of tasks and levels of work difficulty that will be required of positions that will be given this title and shall not be construed as declaring what the specific duties and responsibilities of any particular position shall be. It is not intended to limit or in any way modify the right of any supervisor to assign, direct and control the work of employees under their supervision. The use of a particular expression or illustration describing duties shall not be held to exclude other duties not mentioned that are of similar kind or level of difficulty. Doc ID: 35078ac3adb0eed686abfd9301ae37d5e5a9547e School/College/Division: H09 - Research Primary department: H0955 - Human & Animal Resource Compliance Employment type: + Regular Employee + Job type: Full Time + Job category: Staff/Administrative Funding/salary information: + Compensation type: Annual Salary + Salary minimum: $57,791 + Salary hire maximum: $69,352 Working conditions: Normal office environment. This position must be filled pursuant to the provisions of a collective bargaining agreement, and as such may be filled by a qualified bargaining unit member, should one apply. Job openings: + Number of openings: 1 + Reposted position: Yes + Reposted reason: CUSTOM.REPOSTINGREASON + Prior posting/requisition number:REQ2115 Background check requirements: University policy requires certain persons who are offered employment to undergo a background check, including a criminal history check, before starting work. If you are offered employment, the university will inform you if a background check is required. Equal employment opportunity statement: Wayne State University provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. The university encourages applications from women, people of color and other underrepresented people. Wayne State is an affirmative action/equal opportunity employer.
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