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Office of Research Integrity and Protections and Institutional Review Board Manager

4 months ago

Syracuse, United States Syracuse University Full time

Job Description

Reporting to the Director of the Office of Research Integrity and Protections (ORIP), the ORIP/IRB Manager in collaboration with the Director is responsible for the administration and implementation of the Human Research Protection Program (HRPP) and Institutional Review Board (IRB) policies and procedures related the conduct of human subjects research studies at Syracuse University. In addition, the Manager is responsible for administrative responsibilities within the ORIP Office. The Manager assists in ensuring all human subjects research activities conducted at Syracuse University comply with federal regulations, state and local law, and institutional policies. The Manager develops and implements outreach and education activities for faculty, IRB members, and students related to human subjects research. The Manager is responsible for the management and review of IRB protocol applications. This role also supports the IRB and is responsible for preparing meeting agendas and materials, taking meeting minutes, and communicating IRB determinations. Qualifications Bachelor’s degree with two (2+) plus years of experience related to general research activities required.Working knowledge of federal regulations protecting human subjects required.Experience working in an academic setting preferred.Three (3+) plus years of direct human subjects research protection/IRB regulatory experience reviewing and processing IRB submissions preferred. Job Specific Qualifications General knowledge of regulatory information regarding the use of human participation in research and teaching.Demonstrate understanding of the principles of human research protection standards.Strong decision-making skills and demonstrated ability to assess multiple issues analytically in order to apply knowledge of federal regulations and institutional policy to a variety of situations and research protocols. Responsibilities Management and review of Human Subjects Research Applications.Conduct a preliminary pre-review of expedited and full board IRB applications.Consolidate reviewer comments into clear and concise communication to investigators, and evaluate actions taken by investigators in response to IRB reviewer comments.Support IRB convened meetings including pre-, intra- and post meeting activities in partnership with the Director and IRB Chair; including agenda management, meeting facilitation and all aspects of IRB minutes documentation.Manage and maintain IRB records (correspondence, meeting minutes, annual status reports, reminders, protocol closings).Provide protocol information to the Office of Sponsored Programs and the Office of Sponsored Accounting to confirm sponsor compliance requirements.Support Director and Assistant Director of HRPP in elevating current protocol management, submission and review procedures to an efficient electronic protocol management system.Outreach, education and advising investigators and research staff regarding IRB protocol preparation.Provide consultation to investigators and their research teams regarding federal and state regulations, institutional policies and HRPP procedures to facilities review and approval of submissions.Provide guidance regarding research review categories and help investigators identify which review process and procedures to follow before protocol submission.Assist with development of HRPP policies, procedures, forms and website content to deliver clear and consistent education and information to the research community.Independently design and present educational materials for presentations on human subjects research at various levels of the University and provide instruction in classrooms, departments and in small and large group forums.Inform research participants of their rights as a participant. Field incoming calls from research participants, answer questions and make referrals to HRPP leadership as needed.Development of IRB/HRPP Policies, Guidance and Standard Operating Procedures.Assist with the development and updates of HRPP policies and procedures.Help to identify programmatic gaps and assist the Director with drafting SOP’s to fill gaps. Responsibilities related to the Office of Research Integrity and Protections.Manage website information on ORIP’s main page.Complete monthly departmental budget reconciliations.Serve as the primary contact for the Collaborative Institutional Training Initiative modules for all areas of research compliance (Human Research, Animal Research, Responsible and Ethical Conduct of Research, Technology Transfer, Conflicts of Interest, Institutional Biosafety Committee, Foreign Influence and Export Controls).Participate in position appropriate trainings and professional development opportunities. Physical Requirements * Tools/Equipment *