The University of South Alabama's department of Research Compliance and Assurance is seeking to hire an Institutional Review Board (IRB) Administrator. This is full-time position, in-person office hours only. Essential duties include, but not limited to:
- Attains and maintains comprehensive and up-to-date knowledge of human subject research protections and Institutional Review Board (IRB) regulations as contained in 45 CFR 21 CFR 50 & 52, and other applicable regulations.
- Serves as the subject matter expert by providing guidance and training to researchers, faculty, staff, students, and IRB members.
- Oversees the day-to-day administrative operations of the IRB submission, review, and approval process.
- Ensures compliance, high quality review, and efficiency in IRB operations.
- Manages all aspects of IRB committee meetings, including ensuring adequate meeting attendance to conduct meetings, reviewer assignments, staff support, technical support, agenda creation, meeting minutes, and supporting the IRB chair in managing the meeting.
- Manages the IRB reliance program, including tracking of reliance agreements and procedures for reliance through various organizations and mechanisms, including review and oversight of collaborative research with the University.
- Oversees the continued expansion and streamlining of the reliance processes.
- Analyzes and reviews applications for the IRB to ensure completeness and compliance with appropriate federal and state laws, institutional policies, and University IRB guidelines.
- Responsible for administrative review and management of all External IRB submission requests (commercial IRBs, NCI IRB, and other independent external IRBs).
- Corresponds with researchers, articulating required modifications to study documentation, including informed consent forms, in order to secure IRB approval, and requesting additional information needed before approval can be considered.
- Maintains active knowledge of regulations and ethical norms applicable to human subject's research through professional development activities.
- Performs other duties as required and participate in special projects as assigned.
- Works cooperatively with other Research Compliance staff and coordinates efforts with the office, including providing coverage as needed.
- Prepares board documents for deliberation at IRB meetings, attends IRB meetings, prepares meeting minutes, and communicates IRB determinations and actions to researchers.
- Works with Research Quality and Improvement team to help develop tools, templates and guidance to support the research community.
- Works collaboratively in identifying, correcting and preventing potential problems.
- Collaborates with Executive Director and the Associate Director, Research Quality and Improvement to identify focus areas for monitoring, systems improvements, policy/procedure development/revision and education to ensure a high quality, compliant, and efficient human subject's research program.
- Develops and participates in training and educational activities on human research protections that are presented to researchers and administrators.
- Serves as the subject matter expert by providing guidance and training to researchers, faculty, staff, students, and IRB members.
- Trains new IRB members and clinical research regulatory staff on how to use the electronic review system and facilitates onboarding.
- Works with Executive Director in the review and updates of new member orientation materials.
- Provides guidance to researchers and administrators on the use of the online electronic management systems used by the University to manage applications for review and automate correspondence.
- Works with Executive Director and team members in keeping website material up-to-date and in the development of educational resources.
- Assists the Executive Director with policy and guidance revision, procedural changes and other IRB programmatic issues.
- Develops and implements education sessions on topics related to human subject's research protections to research community and IRB members.
Minimum Requirements:
Bachelor's degree in a related field from an accredited institution as approved and accepted by the University of South Alabama and five years of related professional experience. An equivalent combination of education and experience may be considered.
Preferred Qualifications:
Certified IRB Professional (CIB) is preferred and will substitute for one year of the required experience.
Interested candidates should apply at: https://southalabama.peopleadmin.com/postings/40139
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Dusty Layton
Director, Research Compliance and Assurance
University of South Alabama
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