Essential Functions: Job PurposeThe IRB Training Coordinator is the primary educator and informational resource for the research community, Institutional Review Board (IRB) members, faculty, and staff, responsible for various educational activities related to the WSU IRB.Essential Functions Develop and maintain a comprehensive education program for the protection of human participants in research. Convey investigator responsibilities of IRB and regulatory reporting to the research community in order to maintain and promote compliance at WSU.Develop, maintain, and deliver IRB trainings on a variety of topics at a variety of locations and times, associated with IRB submissions, review, and approval of human research protocols. Develop and deliver individual sessions for faculty, affiliates, staff, and students who wish to conduct human participant research. Coordinate with various academic units to develop and conduct training programs unique to their fields. Conduct investigator training as directed by the IRB. Develop, coordinate and deliver trainings and educational materials for IRB members, prospective IRB members and IRB staff as directed.Monitor changing regulatory landscape, assisting in writing IRB policies and procedures to remain current with regulatory requirements and guidance. Responsible for assuring that all educational materials, tools, and resources are in strict compliance with federal and state regulations and Institutional policies governing human research. Develop and maintain educational materials, documents, resources and tools for the research community, IRB members, and IRB staff to aid in understanding all interactions with the IRB and regulatory bodies. Develop, coordinate and deliver annual and on-going trainings and educational materials for IRB members and for IRB staff, as directed by the Associate Director, IRB Administration.Serve as an educational resource on regulatory, policies, processes, responses to and from the IRB. Field and answer questions for IRB members and the research community on a daily basis. In collaboration with the Associate Director, IRB Administration Operations management, maintain IRB policies and procedures and IRB forms. Ensure that changes to regulations and guidance are reflected in the policies and forms. Review and triage inquiries as to whether a study is considered human participant research, quality improvement or research, deferring to the appropriate IRB Chair for difficult decisions. Process Administrative Application submissions and ceding IRB authority requests. Assist with preparing for audits by federal regulatory agencies, regulatory bodies, and accreditation bodies (Food and Drug Administration, Office for Human Research Protection, AAHRPP, VA, etc.) Assist with Single Time Use Processing and Administrative Application Submissions as needed.Perform other duties as assigned.
Qualifications: MINIMUM QUALIFICATIONSEducation Bachelor's degreeB.S. degree or higher preferred in education or a health care field such as Pharmacy or Nursing, with at least 2 years experience in research, patient care, and/or research administration. Experience Experienced (minimum 2 years of job-related experience) 1-3 years teaching experience, preferred.1-3 years experience in IRB, research field, or similar. Some knowledge of psychological, pharmaceutical, medical and/or drug agency research.Must have or obtain CIP certification within 1 year of being hired and maintain this certification.Knowledge, Skills and AbilitiesAbility to interact professionally with MDs and PhDs. Effective speaking, writing, typing and communication skills. Knowledgeable of research compliance regulations including OHRP, FDA, DoD, DHHS, VA, etc., as well as accreditation standards including AAHRPP. Knowledge and experience with University policies, procedures and practices surrounding the approval of research. Knowledge of and ability to proficiently use a PC and computer based applications. Attention to detail and ability to continuously multi-task in a fast-paced work environment are essential to succeed in this position. Ability to establish and meet deadlines, work under extreme pressure and function independently. Strong analytic and problem solving skills. Ability to work occasional evenings and early mornings, as needed by research community for presentations, etc.
Founded in 1868, Wayne State University is a nationally recognized metropolitan research institution offering more than 400 academic programs through 13 schools and colleges to nearly 32,000 students. Wayne State?s main campus in Midtown Detroit comprises 100 buildings over nearly 200 acres; its five extension centers offer higher education to people throughout Southeast Michigan. Wayne State is d...edicated to preparing students to excel by combining the academic excellence of a major research university with the practical experience of an institution that by its history, location and diversity represents a microcosm of the world we live in. Reflecting its location and the excellent international reputation of its graduate schools, particularly in the sciences, Wayne State boasts the most diverse student body among Michigan?s public universities. Its students represent 49 U.S. states and more than 60 countries.