Responsible for administrative duties for human subjects research, the daily activities associated with the processing of research protocol correspondence and support for the operational needs of the Institutional Review Board. The position will also assist in ensuring compliance with the Conflict of Interest policies.
Intake review of submitted human subjects research applications. Prepare and distribute letters with IRB deliberations to principal investigators to communicate the decisions of the IRB, coordinate IRB meetings, coordinate a team approach to produce the monthly IRB agenda for each meeting and ensure that materials are distributed within established guidelines, record deliberations, and write meeting minutes, printing and preparation of protocols for IRB action. Maintain all physical and electronic IRB files, provide guidance and clarification to investigators in adhering to federal, state, and local regulations, policies and guidelines, document and ensure the veracity and completeness of all protocol actions, meeting agendas and minutes, non-compliance reports, provide administrative support for committee meetings, including organizing, coordinating and preparing for the meetings. Liaison between ORS and the University research community, primary CITI education contact for investigators and coordinators, assist with training and orientation tasks of new committee members, assist in conducting customized training sessions, Work with co-workers to design, develop, and present training programs for IRB proposals. Work with the Sr. Program Coordinator in ensuring the University's compliance with PHS and other regulations regarding researchers' disclosure of financial interests and management of financial conflicts of interest, assist Sr. Program Coordinator with the in-take and review process of financial interest disclosure forms.
Other related functions as assigned.
Bachelor degree and five years of combined experience in the following: in a research/science-based field, including social/behavior sciences, working knowledge of regulations concerning human research protections or previous IRB-related experience. Demonstrate skill in taking initiative, working with minimal supervision in a team setting and detail-oriented. Have writing, oral communication and strong interpersonal skills. Experience with computerized databases and Microsoft Office is essential. Must possess effective planning and organizational skills. Must be able to set priorities, meet deadlines, and manage multiple projects. Professional demeanor. Equivalent combination of relevant education and experience may be substituted as appropriate.
Masters degree plus three years personal research experience with human subjects research. Experience in auditing or quality assurance. Experience in reviewing and editing social behavior or clinical research proposals and applying federal rules and regulations. Experience with IRB administration, education and training. Advanced analytical skills. CIP certified or eligible within one year to become CIP certified.
May work around standard office conditions Repetitive use of a keyboard at a workstation