Institutional Review Board (IRB) Administrator

Minimum Qualifications

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. Job Description Summary The University of South Alabama’s department of Research Compliance and Assurance is seeking to hire an Institutional Review Board (IRB) Administrator. Interested candidates should apply to be considered. Essential Functions These are the job duties required of the position. Essential Functions

• 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.
• Determines whether research projects are exempt from further review.
• Reviews and approves certain research projects on behalf of the IRB as a designated reviewer.
• 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.
• Conducts quality control functions in areas of operation to include review of files and meeting minutes for completeness, accuracy, and consistency.
• Assists the Executive Director with policy and guidance revision, procedural changes and other IRB programmatic issues.
• Assists Executive Director in the preparation of any announced federal regulatory inspections of the IRB.
• Develops and implements education sessions on topics related to human subject’s research protections to UIC researchers and IRB members.
• Anticipates future application submission for the Association for the Accreditation of Human Research Protection Program (AAHRPP) accreditation.
• Assist the Executive Director in maintaining full AAHRPP accreditation for the institutional human research protection program.
• Assists with draft AAHRPP accreditation renewal applications, annual reports, training materials for site visits, and responses to site visits.
• This is an in person position.
• Regular and prompt attendance.
• Ability to work schedule as defined and additional hours as required.
• Related duties as required.

Posting Information

Benefits

Paid Time Off (PTO) Health Insurance Short Term Disability Life Insurance Education Benefit Retirement Plan Memberships and Events Student Loan Forgiveness Paid Time Off (PTO) Employees earn paid time off (PTO) as they work. PTO can be used for vacation, holidays, sick days and personal days. Each year, employees can choose to cash out up to 80 hours of available PTO the following calendar year. Health Insurance New employees health, dental, and pharmacy benefits are effective the first day of the month following hire date. Short Term Disability This free benefit provides income support for those who are out of work for a medical reason, such as illness, accident or maternity. After a seven-day waiting period, it provides a 60-percent wage replacement, up to $1,000 per week for 90 days. Life Insurance USA Health provides a free term life insurance policy for our employees based on annual salary. Policies for spouse and dependents are also included. Additional coverage can be purchased for employee, spouse and dependents. Education Benefit University of South Alabama offers a credit on tuition each semester for employees, spouse, and dependents after just six months of employment. Retirement Plan USA Health offers a 5% matching retirement account and other non-matching account choices. Included with this benefit is a free individual session with a financial planner. Memberships and Events Employees can join USA’s state-of-the-art recreation center for a nominal fee. USA football season tickets are available at a discount, and employees can attend all other USA sporting events for free. Student Loan Forgiveness As an employee of a government or not-for-profit organization, you may be eligible for the Public Service Loan Forgiveness Program through the U.S. Department of Education.