JOB DESCRIPTION AND POSITION REQUIREMENTS:
The Office of Research Protections within the Office of the Senior Vice President for Research is looking for a Senior IRB (Institutional Review Board) Analyst , who will assist in providing leadership to the Full Board Team and work in collaboration with all members of the Human Research Protection Program (HRPP).
The Senior IRB Analyst will report to the IRB Assistant Director of the Human Research Protection Program (HRPP) in the Office for Research Protections and manage a team.
Work Arrangement: This position will be primarily remote within the US with limited on-campus meetings or in-person educational events. Standard work times will be in EST.
Responsibilities: Following are the key responsibilities of this position:
- 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.
- 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.
- This role will assist the Reliance, Regulatory Support and Outreach team of the HRPP in conducting internal HRPP quality assurance audits and preparing reports detailing the associated findings to HRPP leadership. They will maintain appropriate documentation of compliance reviews and determinations as required by federal regulations and by University policy.
- Assist faculty, students and staff in the regulatory preparation of human research protocols for compliance review, develop and maintain IRB staff training materials, and 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.
- Oversee and monitor the Full Board 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.
- Interact with other University compliance committees and various other offices such as information security, grants/contracts, and the Office of General Counsel.
- Support the Assistant Director with developing and delivering education to IRB members and attend IRB meetings to ensure efficient and effective conduct of meetings. In addition, the Senior IRB Analyst will collaborate with the Assistant Director to develop, update, and maintain IRB policies and guidelines, standard operating procedures, and submission forms.
Education and Experience: This position at the minimum requires a Master’s degree or higher and 6+ years of experience in the human subject research regulatory field or an equivalent combination of education and experience in the human subject research regulatory field and performing human subject research.
Individuals must have a solid working knowledge of federal regulations and professional standards regarding the protection of human research subjects. Knowledge of AAHRPP accreditation standards is desired. CIP (Certified IRB Professional) credential is required within one year of eligibility. Experience in conducting human research is a plus. Proficiency with Microsoft Office is required and knowledge of and experience with electronic data management systems is strongly desired.
Experience with managing and supervising others is expected. The ability to work efficiently in a complex regulatory environment and manage multiple simultaneous projects with meticulous attention to detail is critical. 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 successful candidate will have excellent communication skills, embrace, and foster diversity and teamwork, and resolve issues with a strong service-minded approach.
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.
Penn State offers competitive benefits to full-time employees, including medical, dental, vision, and retirement plans, in addition to tuition discounts (75% discount for spouse and children), and paid holidays.
The salary range for this position, including all possible grades is:
$61,800.00 - $89,600.00
