Assistant Director of IRB – Full Board Team
• Job Description:
• 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
• Requirements:
• 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
• 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
• 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
• Benefits:
• Comprehensive medical, dental, and vision coverage
• Robust retirement plans
• Substantial paid time off which includes holidays, vacation and sick time
• Generous 75% tuition discount available to employees and their eligible spouses and children
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• 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
• Requirements:
• 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
• 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
• 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
• Benefits:
• Comprehensive medical, dental, and vision coverage
• Robust retirement plans
• Substantial paid time off which includes holidays, vacation and sick time
• Generous 75% tuition discount available to employees and their eligible spouses and children
Apply tot his job
Apply To this Job