Part-Time IRB Reliance Administrator – Office of Human Research Protections
Job Description:
• Manage the Single IRB (sIRB) and Central IRB (cIRB) review process
• Guide investigators relying on external IRB in processing the ancillary reviews and paperwork
• Assist IRB administrators and OHRP leadership by providing expert regulatory advice
• Process all IRB reliance agreements
• Independently reviews and approves reliance requests
• Evaluates requests against established criteria
• Drafts agreements using established templates
• Communicates with non-WVU IRB staff, researchers, and other administrative offices to negotiate changes
• Reviews research-related events on reliance-specific studies
• Coordinates agreements with other compliance and regulatory requirements
• Provides regulatory advice and consultation to IRB staff and researchers
• Updates and develops training documents for members of the research community
• Manages post-approval monitoring and education activities
Requirements:
• Bachelor’s degree
• A minimum of three (3) years of experience in a human research office or research administration office supporting human research activities
• Any equivalent combination of related education and/or experience will be considered
• Computer proficiency is required, including MS Word, Excel, internet browsers, and email
• Working knowledge of federal, state, and local laws and regulations governing human subject research
• Demonstrated experience at managing, tracking, organizing, prioritizing and documenting large volumes of complex tasks and information
• Significant working knowledge of research procedures and terminology
• In-depth understanding of operational requirements pertaining to management and implementation of protocol process
• Demonstrated experience involving outstanding attention to detail
• Knowledge of reliance agreement documents and systems (e.g., SMART IRB, IREx, Huron IRB Exchange, etc.)
• Exceptional oral and written communication skills
• Excellent organizational skills with ability to prioritize work and adhere to office timelines
• Ability to assess institutional and federal criteria, apply to a variety of situations, and make decisions based on specific criteria.
Benefits:
• Paid holidays
• Annual leave (vacation) days per year
• Sick days per year
• Range of health insurance and other benefits
• 401(a) retirement savings with 6% employee contribution match
• Eligibility to continue health insurance
• Other retiree perks
• Wellness programs
• Manage the Single IRB (sIRB) and Central IRB (cIRB) review process
• Guide investigators relying on external IRB in processing the ancillary reviews and paperwork
• Assist IRB administrators and OHRP leadership by providing expert regulatory advice
• Process all IRB reliance agreements
• Independently reviews and approves reliance requests
• Evaluates requests against established criteria
• Drafts agreements using established templates
• Communicates with non-WVU IRB staff, researchers, and other administrative offices to negotiate changes
• Reviews research-related events on reliance-specific studies
• Coordinates agreements with other compliance and regulatory requirements
• Provides regulatory advice and consultation to IRB staff and researchers
• Updates and develops training documents for members of the research community
• Manages post-approval monitoring and education activities
Requirements:
• Bachelor’s degree
• A minimum of three (3) years of experience in a human research office or research administration office supporting human research activities
• Any equivalent combination of related education and/or experience will be considered
• Computer proficiency is required, including MS Word, Excel, internet browsers, and email
• Working knowledge of federal, state, and local laws and regulations governing human subject research
• Demonstrated experience at managing, tracking, organizing, prioritizing and documenting large volumes of complex tasks and information
• Significant working knowledge of research procedures and terminology
• In-depth understanding of operational requirements pertaining to management and implementation of protocol process
• Demonstrated experience involving outstanding attention to detail
• Knowledge of reliance agreement documents and systems (e.g., SMART IRB, IREx, Huron IRB Exchange, etc.)
• Exceptional oral and written communication skills
• Excellent organizational skills with ability to prioritize work and adhere to office timelines
• Ability to assess institutional and federal criteria, apply to a variety of situations, and make decisions based on specific criteria.
Benefits:
• Paid holidays
• Annual leave (vacation) days per year
• Sick days per year
• Range of health insurance and other benefits
• 401(a) retirement savings with 6% employee contribution match
• Eligibility to continue health insurance
• Other retiree perks
• Wellness programs