Job Details
Posting Title
IRB ("Institutional Review Board") Coordinator
Overview
The Office of Sponsored Programs administers the university's research operations. The office coordinates all pre- and non-financial post-award functions for grants and research. It maintains the university's Protection of Human Subjects program. The IRB ("Institutional Review Board") Coordinator will serve as the primary regulatory resource for investigators regarding the protection of human subjects in research. With an extensive understanding of human research regulations and federal guidance, the incumbent will manage the IRB process at the university, and advise and assist investigators regarding federal, local, and university policies regarding compliance. Prepare materials and track the review process, while supporting the IRB committee.
Responsibilities
Maintain committee operations and meeting schedules. Review submitted protocols for completeness and compliance of federal and institutional guidelines. Review Informed Consent documents for content completeness and federally mandated elements. Work with investigators to ensure completeness of applications, and write correspondence to investigators to communicate decisions of the IRB. Evaluate reports of unanticipated problems, process amendments and renewals, and prepare recommendations for the committee regarding exemptions. Report serious non-compliance issues. Monitor regulatory environment and recommend changes as needed to university policies, processes, and guidelines. Attend IRB meetings, record deliberations, and write meeting minutes. Ensure that minutes are accurately recorded, and prepare final version for Chair approval. Assist with training of students and faculty on all IRB processes and procedures. Maintain knowledge of Federal regulations regarding protection f humans subjects, to include working knowledge of 21 CFR parts 50, 56, 312, and 812, and 45 CFR 46.
Qualifications
Master's degree preferred, either in biomedical or social and behavioral disciplines. 3-5 years of experience working in IRB operations. Administers and coordinates all functions of the Institutional Review Board (IRB). This includes receiving and reviewing research proposals for completeness and adherence with IRB policies, institutional requirements, and State/Federal codes, rules, and regulations (45 CFR 46). Work involves planning, developing, and implementing IRB policies and procedures and providing technical assistance to faculty staff, students, other agencies and universities, researchers/principal investigators, and the public. Maintains records of all activities and communications, writes minutes and reports on the activities of the IRB. Provides orientation and training to all IRB committee members to maintain up to date knowledge of state and federal regulations as well as policies, guidelines and ethical codes related to the protection of human subjects and privacy and to avoid conflict of interests. CIP or CIM certification preferred. Potential for position to expand to include animal research duties as well.