The Research Office of Human Research Protections at West Virginia University is currently accepting applications for an IRB Reliance Administrator. About the Opportunity Under the general direction of the Assistant Director, this individual will be responsible for managing the Single IRB (sIRB) and Central IRB (cIRB) review process in the WVU Office of Human Research Protections (OHRP). This position will guide investigators who are relying on an external IRB in processing the ancillary reviews and paperwork associated with the sIRB/cIRB process and will assist IRB administrators and OHRP leadership by providing expert regulatory advice in situations where WVU IRB has agreed to serve as the IRB of Record. In addition, this individual will process all IRB reliance agreements. We strongly believe in work-life balance and keeping time for things we love outside our work. WVU offers generous benefits, including:

• Paid holidays (staff holiday calendar)
• Annual leave (vacation) days per year
• Sick days per year (for when you’re ill, for when you need time to care for sick family, for your own, or your family’s, regularly scheduled medical appointments. Who is family for the purpose of this leave? A lot of people in your life including immediate relatives and in-laws as well as others considered to be members of your household living under the same roof)
• WVU offers a range of health insurance and other benefits (this position is a benefits-eligible, staff position)
• 401(a) retirement savings with 6%25 employee contribution match, eligibility to continue health insurance, and other retiree perks. Looking for more retirement benefits information? Check out retirement health insurance benefits, retirement income, and FAQ’s.
• Wellness programs

What You'll Do

• Compliance Analysis for WVU studies reviewed by a non-WVU IRB
• Independently reviews and approves reliance requests for non-WVU IRB review of WVU research. The review requires evaluation of requests against established criteria and may also involve drafting agreements using established templates, reviewing other non-WVU institutional templates to ensure required elements are present, and communicating with non-WVU IRB staff, researchers, and other administrative offices to negotiate any changes.
• Independently reviews and provides determinations regarding individual and institutional engagement in research involving human subjects.
• Provides WVU local context information to other IRBs and reviews changes in the research that may impact WVU local context requirements.
• Documents outcomes and communicate decisions to researchers.
• Ensures all documentation has been submitted accurately in the electronic IRB system.
• Reviews research-related events on reliance-specific studies reviewed by a non-WVU IRB, which may include non-compliance, deviations, complaints, and violations by researchers and forward to the appropriate parties for possible action.
• Compliance Analysis for multi-institutional research reviewed by the WVU IRB
• Independently conducts regulatory assessments and IRB review of materials describing proposed multi-institutional human subjects research.
• Independently makes and documents numerous required regulatory determinations about the proposed research and scholarly activities, including: identification of activities requiring IRB review, identification of which participating groups must be considered human subjects, whether the activity is eligible for the use of WVU IRB, required type of IRB review, and identification of all state and federal regulations.
• Manages the review and approval of reliance requests for WVU IRB review of research on behalf of non-WVU institutions. The review requires evaluation of requests against established criteria and may also involve drafting agreements using established templates, reviewing other non-WVU institutional templates to ensure required elements are present, and communicating with non-WVU IRB staff, researchers, and other administrative offices to negotiate any changes.
• Reviews research-related events, which may include non-compliance, deviations, complaints and violations by researchers and forward to the IRB for possible action. Communicate and translate IRB decisions for the research-related events to researchers at participating sites and to federal regulatory agencies (when required).
• Coordinates these agreements with other compliance and regulatory requirements.
• Obtains local context from relying institutions.
• Documents outcomes and communicates decisions to OHRP staff and researchers. 30%25 - Consultation and Education
• Provides regulatory advice and consultation to IRB staff and researchers regarding WVU OHRP’s policies for reliance and Single IRB review, WVU’s established broad institutional agreements for ceding IRB review, and study-specific reliance agreements, including post-authorization or post-approval compliance audit and educational activities.
• Provides help and training to investigators, research coordinators, IRB members, IRB staff, and any other groups within the institution.
• Updates and develops training documents for members of the research community, IRB members, IRB staff, and any other groups within the institution.
• Develops and maintains good working relations with members of the research community.
• Manages post-approval monitoring and education activities with direction from the Assistant Director and in conjunction with the Continuous Quality Improvement and Education Coordinator.
• Consults with WVU legal counsel (and other WVU offices, as necessary) on reliance agreements requiring additional review and/or input.
• Serves as the subject matter expert and liaison for IRB Reliance Agreements, Single IRB (sIRB), and Central IRB (cIRB) protocols.
• Regularly consults with researchers on individual projects involving reliance and/or external collaborations.
• Be familiar with and assist others in the development of research protocols, amendments, continuing renewals, and other documentation in the electronic administration system.
• Bachelor’s degree
• A minimum of three (3) years of experience in the following:
• Direct and progressively responsible 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.
• All qualifications must be met by the time of employment.

Knowledge, Skills, and Abilities

• 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, specifically in regard to multi-site research where a Single IRB or Central IRB is involved.
• Demonstrated experience involving outstanding attention to detail.
• Knowledge of reliance agreement documents and systems (e.g., SMART IRB, IREx, Huron IRB Exchange, etc.)
• 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, specifically in regard to multi-site research where a Single IRB or Central IRB is involved.
• 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.

Preferred Qualifications

• Master’s degree
• Certified IRB Professional is highly desired