Compliance Specialist 4 (Institutional Review Board Analyst)
Job Number: REQ_0000014572
CURRENT EMPLOYEES OR STUDENTS:
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JOB DESCRIPTION AND POSITION REQUIREMENTS:
The Pennsylvania State University is a land-grant Research 1 (R1) university with campuses and facilities throughout Pennsylvania, conducting teaching, research, and public service. The Office for Research Protections (ORP) at Penn State ensures that research at the University is conducted in accordance with federal, state, and local regulations and guidelines that protect human participants, animals, students, and personnel involved with research.
Under ORP, the Institutional Review Board (IRB), which is the federally mandated entity overseeing the protection of human subjects in research, is looking for IRB Analysts. The IRB Analyst will report to an Assistant Director in the Human Research Protection Program and work in collaboration with IRB Analysts, the IRB Director, and the IRB committee.
This individual's primary responsibility will be as follows:
- 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.
- Maintain appropriate documentation of compliance reviews and determinations as required by federal regulations and by University policy.
- 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, the College of Medicine, 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.
- Interact with other University compliance committees and various other offices such as the Office of Research Protection at University Park, Office of Sponsored Programs, Office of General Counsel, Office of Information Security, and faculty, staff, and students of all Penn State campuses.
- Collaborate in writing, periodically reviewing and updating IRB policies and guidelines, standard operating procedures, and submission forms.
This position will work remotely with limited on-campus meetings or in-person educational events.
This position typically requires a Bachelor's Degree or higher plus 6+ years of experience with research or research-related activities or an equivalent combination of education and experience. Proficiency with Microsoft Office is required and knowledge of and experience with electronic data management systems is strongly desired. 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 re-prioritize work to ensure work is completed on time. CIP (Certified IRB Professional) credential required within one year of eligibility. 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.
The Pennsylvania State University is committed to and accountable for advancing diversity, equity, and inclusion in all of its forms. We embrace individual uniqueness, foster a culture of inclusive excellence that supports both broad and specific diversity initiatives, leverage the educational and institutional benefits of diversity, and engage all individuals to help them thrive. We value inclusive excellence as a core strength and an essential element of our public service mission.