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Compliance Specialist 4 (Institutional Review Board Analyst)

Job Description

Compliance Specialist 4 (Institutional Review Board Analyst)
The Institutional Review Board (IRB) Analyst (?Analyst?) will report to the Director of the IRB Program Director (?Director?) in the Office for Research Protections and work in collaboration with IRB Analysts, the IRB Program Coordinator, and the IRB committee. This individual?s primary responsibility will be to review human research protocols for compliance with governmental regulations and University policy, initiate clear and accurate written correspondence and/or telephone contact with investigators and staff, and request clarification and/or additional information to enable sound judgments to ensure compliance. They will maintain appropriate documentation of compliance reviews and determinations as required by federal regulations and by University policy. The individual will assist faculty, students and staff in preparing human research protocols for compliance certification, develop and maintain IRB training materials, present seminars/workshops at University Park and other campus locations to faculty, staff and students about regulations and policies governing human participants involved in research at Penn State, and review, prepare, and facilitate agreements for IRB reliance. The Analyst will interact with other University compliance committees and various other offices such as the Human Subjects Protections Office at the College of Medicine, Office of Sponsored Programs, Office of General Counsel, Office of Information Security, and faculty, staff, and students of all Penn State campuses. In addition, the Analyst will collaborate in writing, periodically reviewing and updating IRB policies and guidelines, standard operating procedures, and submission forms. Typically requires a Bachelor's degree or higher plus six years of related experience, or an equivalent combination of education and experience. Knowledge of and experience with electronic data management systems is strongly desired. Individuals with knowledge of federal regulations and professional standards regarding the protection of human research participants or experience in conducting human research are preferred and strongly encouraged to apply. Minimum Qualifications: Proficiency with Microsoft Office is required. Ability to work efficiently in a complex regulatory environment is critical. This includes excellent interpersonal and communication skills. Individual must have the ability to manage multiple simultaneous projects with meticulous attention to detail. This individual must be able to work effectively with minimal supervision and demonstrate significant autonomy and judgment with the ability to multi-task and independently reprioritize work to ensure work is completed on time. CIP (Certified IRB Professional) credential required within one year of eligibility.

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Compliance Specialist 4 (Institutional Review Board Analyst)
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