Assistant Director of IRB (Full Board Team) - Office of Research Protections

Penn State’s Human Research Protection Program (HRPP) in the Office for Research Protections (ORP) is seeking a collaborative, motivated and experienced individual for the position of Institutional Review Board (IRB) Assistant Director, Full Board Team. This position will be filled at the Research Compliance Manager - Manager level. The IRB Assistant Director will report to the IRB Director and will supervise a team comprised of one Senior Team Lead and five IRB Analysts and will collaborate with all members of the HRPP. The ORP, part of the Office of the Senior Vice President for Research, plays a pivotal role in supporting Penn State’s diverse research community, boasting an annual research expenditure over $1 billion and ranking among the top 30 public research universities in the nation. Penn State University is a land-grant Research 1 (R1) university with campuses and facilities throughout Pennsylvania, conducting teaching, research, and public service. The HRPP provides oversight for all human subjects research conducted by Penn State faculty across the university, including the commonwealth campuses and any Penn State Health location where research is conducted by Penn State faculty. 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 Eastern Standard Time (EST). Responsibilities: Following are the key responsibilities of this position:

• Overseeing the daily operations of the Full Board Team including providing guidance to the team on interpretation and compliance with federal, state, and institutional requirements.
• Managing operations of PSU’s IRB Committees including maintaining IRB rosters, attending meetings to serve as a regulatory expert, and voting member where appropriate, tracking member attendance, assigning submissions to meetings, and ensuring appropriate documentation of IRB meeting minutes as required by federal regulations and by University policy.
• Onboarding, training, and performing evaluations of IRB members and developing and maintaining IRB member continuing education.
• Developing, updating, and maintaining IRB policies, guidelines, standard operating procedures, and submission forms in response to regulatory and institutional changes and feedback received by the HRPP.
• Developing and maintaining IRB training materials, presenting seminars/workshops to the PSU research community about regulations and policies governing human participants in research.
• Assisting with the processing of Reportable New Information submissions and inquiry and/or investigation of non-compliance with IRB policies and applicable federal regulations.
• Serving as a representative of the HRPP and subject matter expert in various capacities both internal within the ORP and external on University level committees and groups where necessary.
• Interacting with other University compliance committees and various other offices such as the Office of Research Information Systems, Office of Sponsored Programs, Office of General Counsel, Office of Information Security, and faculty, staff, and students at all Penn State campuses across the commonwealth.

Required:

• CIP (Certified IRB Professional) credential is required within one year of eligibility.
• In depth knowledge of the laws, rules, and regulations governing human subject research is required.

Skills and Abilities:

• Proven leadership skills, including implementing broad policy recommendations or changes.
• Direct experience with staff selection, training, and performance management within a complex academic or medical research framework.
• Demonstrated ability to work dependably and cooperatively within a fully remote team and to establish and maintain effective and professional interpersonal relationships.
• Sound judgment and decision-making capabilities.
• Strong reading comprehension, written and oral communication, and discretion in handling sensitive information and maintaining confidentiality.
• Exceptional organizational skills and attention to detail.
• Ability to work independently and to concentrate on multiple complex tasks to meet specific programmatic goals in a high-volume, fast-paced environment.
• Proficiency with Microsoft Office and remote meeting platforms such as Zoom.

Preferred Qualifications:

• Knowledge of and experience with electronic data management systems.
• Knowledge of and experience with AAHRPP standards and accreditation requirements.
• Knowledge of HIPAA regulations and state laws governing privacy and security of protected health information.

MINIMUM EDUCATION, WORK EXPERIENCE & REQUIRED CERTIFICATIONS Bachelor's Degree 8+ years of relevant experience, includes 3+ years of supervisory experience; or an equivalent combination of education and experience accepted Required Certifications: None BACKGROUND CHECKS/CLEARANCES Employment with the University will require successful completion of backgro Apply tot his job Apply To this Job