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Wright State University is seeking applications for a full-time Manager of Human Research Protection Program to direct and manage the operations of the Institutional Review Board (IRB) and the university’s human subjects protection program that also provides services to external affiliated research institutions and researchers.
40%: Provides daily leadership, support and guidance to the IRB staff (including direct supervision of the Coordinator, IRB Compliance I), leadership to the part-time InfoEd Module Administrator as the duties apply to the human subjects module, and oversight of the work of the undergraduate student assistant assigned to the IRB. Manages the review and approval process for IRB submissions via the InfoEd Human Subjects module. This includes reviewing applications for completeness and compliance, making exemption determinations, assigning IRB member reviewers, and communicating required revisions and other concerns in written and oral communication to investigators. Responsible for coordinating efforts of the IRB Office staff to ensure thorough and timely reviews of all IRB submissions. Must also manage full board meeting process, which includes scheduling meetings and generating agendas and minutes using InfoEd.
20%: Serves as an expert campus resource for interpreting and applying federal research regulations, policies and procedures related to research protections and compliance. Develops and implements training courses for individual investigators and members of the IRB that include both in-person sessions and online resources for Web accessibility.
15%: Manages the institutional review and approval process for WSU’s reliance on external IRBs. Directly engages with external parties, including the Air Force Research Laboratory and other institutions of higher education, to review and process External Reliance Agreements submitted in InfoEd. These duties require that the individual exhibit independent thinking and decision making. The External Reliance Agreement process requires that the individual negotiate agreements with other organizations and educate WSU investigators on the institutional requirements for these arrangements.
15%: Develop, revise, implement and monitor WSUIRB policies and procedures to ensure compliance with federal regulations, state statutes, and WSUsystemwide policies. This includes independent monitoring and updating submission forms and data fields in InfoEd, as needed.
10%: Maintain the official roster of IRB members, assist in the recruitment of new members, conduct and coordinate initial and continuing education of IRB members, maintain WSU’s Federalwide Assurance with the U.S. Department of Health and Human Services, coordinate non-compliance investigations and coordinate and oversee audits of the IRB; e.g., FDA, etc.
Position will remain open until filled. Wright State University, an equal opportunity/affirmative action employer, is committed to an inclusive environment and strongly encourages applications from minorities, females, veterans and individuals with disabilities.
Bachelor’s degree and a minimum of 5 years related experience - 3 years of progressively responsible IRB administration work experience at a University or hospital system. - Demonstrated expert-level working knowledge of external regulations, laws, statutes and policies regarding the protection of human subjects, including but not limited to, the Common Rule, HIPAA and FDA regulations. - Must be able to independently conduct reviews and audits of IRB protocols that require post-approval monitoring. - Must possess excellent written and oral communication skills. - Must be able to write clear and concise policies, procedures and guidelines related to human subjects’ research and demonstrate the ability to implement and clearly articulate those policies and their underlying principles to a diverse group of internal and external stakeholders. - Must be able to maintain confidentiality in office operational transactions. - Demonstrated ability to make presentations to large and small groups. - Must be able to work with and engage stakeholders independently and use sound judgment when referring issues to higher organizational levels for consideration. - Excellent problem-solving skills and demonstrated ability to resolve conflicts. Preferred: Master’s degree; 5 years of progressively responsible IRB administration work experience at a university of hospital system.
- Master’s degree - 5 years of progressively responsible IRB administration work experience at a University of hospital system. - Knowledge of electronic software solution for submission, review and approval of IRB protocols; e.g., InfoEd.
Internal Number: 19P157
About Wright State University
Wright State University is a national public university in Dayton, Ohio. Offering 295 degree programs, the university is made up of eight colleges, three schools, and a branch campus in Celina, Ohio. Named for the Wright brothers, Wright State University offers an exceptional, affordable education.