1.Conduct pre-review analysis of IRB submissions to ensure applications are adequately prepared and to identify any missing information that would preclude the ability to conduct an adequate review; follow up with investigator/study staff to obtain corrections or needed information; ensure ancillary requirements are in place.
2.Manage IRB Panel operations, including meeting management and pre- and post-meeting activities, maintain comprehensive tracking throughout the course of the review, and maintain appropriate documentation and reporting of review, study status, and panel activities.
3.Conduct IRB review of minor amendments and participate as an alternate voting member, as needed, ensuring that all regulatory and VCU policy criteria are met. Work with investigators/study staff to address any needed revisions. Maintain appropriate documentation and reporting of review and study status.
4.Serve as an educational resource for IRB members, investigators, research personnel, and students.
5.Support the Human Participant Protections Program by maintaining current knowledge of federal and state regulations, research/medical ethics, IRB Written Policies and Procedures, and ORSP business practices.Applies this knowledge to submission screening, IRB review, panel management, and consultations.
Performs highly complex duties to facilitate the review and approval of human participant research to ensure the rights and welfare of participants are protected and research is conducted in compliance with federal, state, and local regulations, and institutional policies and procedures.
The focus of this position will involve conducting substantive pre-review screening of research submissions and managing the operations of an Institutional Review Board.(IRB).
Additional responsibilities will include serving as an IRB member or alternate, including potential participation in convened meeting deliberations and independently conducting exempt and expedited reviews (following demonstrated training and experience), and providing consultation and guidance to researchers and IRB members.
The position requires extensive ability for critical thinking, analytical skills and independent judgment in interpreting and applying relevant regulations and institutional policies; demonstrated effective communication skills for guiding IRB members, chairs, investigators, research staff, and students in how to apply the regulations; and ability to craft complex correspondence to relate IRB determinations. Exceptional organizational skills are required to manage weekly board meetings, track review progress, and ensure tight timelines are met. The position requires a flexible person who has experience in human participant research, and who seeks to ensure comprehensive knowledge and application of federal and state regulations, and institutional policies and procedures pertaining to IRB review of human participant research. This position also requires the ability to learn specific program functions quickly, and someone who is highly skilled in interpersonal relationships, is demonstrably skilled in professional oral and written communication, and is able to deal effectively with high volumes, rigid deadlines, and frequent changes.
Minimum Qualifications: Bachelor’s degree in related field, or equivalent combination of training and experience is required. Training and experience may include working in an IRB office or in the conduct of research studies, and should involve an extensive proven and successful background in critical thinking and analytical review of highly complex information. Ability to communicate requirements verbally and in writing to faculty, staff, and students. Ability to set priorities and manage time effectively, including a demonstrated ability to.plan, organize, schedule, and complete work within deadlines. Ability to perform multiple tasks at any given time with a high level of accuracy and attention to detail. Ability to recognize, analyze, and resolve potential issues/problems. Highly effective interpersonal skills to handle sensitive and confidential situations. Exhibits diplomacy and exceptional customer service. Independent initiative. Ability to work with all levels of individuals in a respectful and supportive manner. High level of proficiency with MS Word, Excel, and PowerPoint, as well as experience using databases. Ability to quickly learn new computer software. A commitment to expand on knowledge of human subjects research regulations and research ethics by attending local, regional, and national conferences/workshops made available to staff. A commitment to help maintain a positive, productive, and healthy office environment. A demonstrated commitment to continuous quality improvement such as identifying areas for increased efficiency or developing solutions to challenges. Perform occasional light (20 lbs.) lifting. Demonstrated experience working in and fostering a diverse faculty, staff and student environment or commitment to do so as a staff member at VCU.
Preferred Qualifications: Knowledge of federal regulations governing human participant research, with the ability to quickly gain a full working knowledge. Ability to analyze regulations and guidances, and apply to written research protocols. Ability to critically read research proposals and determine adherence to regulatory criteria and institutional policy. Ability to guide IRB members in applying regulations to reviews and in the most effective methods for conducting reviews. Currently holds or has the ability to seek certification as a Certified IRB Professional (CIP) upon meeting eligibility requirements.
Internal Number: 567900
About Virginia Commonwealth University
At VCU, we Make it Real through learning, research, creativity, service and discovery — the hallmarks of the VCU experience. A premier, urban, public research university nationally recognized as one of the best employers for diversity, VCU is a great place to work. It’s a place of opportunity, where your success is supported and your career can thrive. VCU offers employees a generous leave package, career paths for advancement, competitive pay, and an opportunity to do mission-driven work.