IRB ADMINISTRATOR SR
Duties: The Senior IRB Administrator serves as reviewer for initial submissions to the IRB that may be eligible for exemption or expedited review. This includes the review of submissions for completeness, eligibility for exempt or expedited level of review, and adherence to institutional policies, regulatory and ethical criteria for approval. He/she works closely with investigators during the review and approval process and advises researchers on regulatory and ethical standards as well as institutional policies and procedures; provides consultation to the research community on submission requirements; provides advice on preparation of IRB applications and associated documents for submission to the IRB. The Senior IRB Administrator acts as a resource to one or more other convened IRBs as required by the Director. The Senior IRB administrator provides support to the IRBs by conducting pre-reviews of requests for modification of previously approved research; requests for continuing approval; potential reportable events; conducting pre-reviews of responses to initial review; and preparing/contributing to agendas, minutes, and correspondence. The Senior IRB Administrator is responsible for support of daily IRB operations, including assignment and oversight of completion of incoming submissions that qualify for expedited review. The Senior IRB Administrator participates in IRB quality improvement initiatives including the review of existing IRB policies and procedures, the provision of training for IRB administrative staff, and other internal QA activities. The Senior IRB Administrator will also work with the Associate Director with community outreach and human subject research educations. He/she is responsible for the yearly performance evaluations of his/her staff and makes recommendations to the Director regarding employee performance.
Qualifications: A Bachelor's Degree (biological sciences preferred) and 3-5 years of regulatory experience and knowledge directly related regulatory review and approval of research or equivalent combination of experience and education (typical experience might include ethics, clinical trial performance, compliance/regulatory or experience in an academic IRB); detailed knowledge of applicable regulations related to the IRB; demonstrated management skills or experience; must be able to work independently with minimal supervision. Outstanding organizational skills and the ability to function in a team environment are required. Qualified candidates must also demonstrate: excellent written and verbal communication skills; advanced computer software skills; a clear attitude of customer service; and the ability to build and maintain positive working relationships at all levels of the institution. Certification as an IRB professional is highly desirable.
Reference Number: 83-26088
Salary Grade: 027
Employment Type: Exempt
Org: Institutional Review Board
Job Family: A-General/Professional Administrative