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The Pennsylvania State University's Human Research Protection Program (HRPP) is seeking a Senior IRB Analyst, who will report to the IRB Assistant Director, to assist in providing leadership to the Expedited/Exempt Team and work in collaboration with all members of the HRPP.
This position is primarily remote with limited on-campus meetings or in-person educational events at any of the Penn State campus locations, particularly University Park and College of Medicine, located in Hershey, PA.
Oversee and monitor five (5) IRB Analysts, informing the Assistant Director of performance issues, assisting in identifying potential solutions to performance issues, and completing the formal performance evaluation of their assigned team. This individual will assist in training new IRB Analysts and will provide on-going guidance on interpretation and compliance with application federal, state, and institutional regulations, guidance, and policies.
Review and approve 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.
Assist faculty, students, and staff in the regulatory preparation of human research protocols for compliance review
Manage the intake and review process of reportable new information, which may include non-compliance or allegations of non-compliance with federal, state, or institutional regulation, policy, or guidance
As needed, assist the IRB Educator in presenting seminars/workshops to Penn State researchers about regulations and policies governing human participants involved in Penn State research
Penn State is committed to an accountable for advancing diversity, equity, inclusion, and belonging in all of its forms. We embrace individual uniqueness, foster a culture of inclusion and belonging that supports both broad and specific diversity initiatives, and leverage the educational and institutional benefits of diversity. We value inclusion and belonging as core strengths and essential elements of our public service mission.
This position will be filled as a level 5; typically requires a Bachelor’s Degree or higher plus 8 years of experience in the human subject research regulatory field or combined years of experience in the human subject research regulatory field and performing human subject research. 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.
A solid working knowledge of federal regulations and professional standards regarding the protection of human research subjects; Knowledge of AAHRPP accreditation standards is desired
Ability to work efficiently in a complex regulatory environment and manage multiple simultaneous projects with meticulous attention to detail is critical
Experience with managing and supervising others is expected
Proficiency with Microsoft Office expected
Knowledge of and experience with electronic data management systems is strongly desired
Requires excellent communication skills and ability to resolve issues with a strong service-minded approach
Certification or eligibility to sit for Certification exam for Certified IRB Professional (CIP)
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