The IRB Specialist of the Institutional Review Board (IRB) reports to the Manager of the Columbia University Medical Center (CUMC) IRB with which the IRB Specialist will be affiliated. The IRB Specialist will join a team of other professionals who are responsible for conducting pre-reviews of submissions to CUMC IRBs, including new protocols, continuing reviews, modifications, and unanticipated problems. This staff member may regularly or on a periodic basis attend IRB meetings and also provide support to his/her Manager, IRB Chair, and IRB Members, including writing and editing minutes of meetings. Additionally, the IRB Specialist will have responsibilities related to the generation, review, and release of IRB correspondence. The IRB Specialist will conduct quality control functions for the IRB office that may extend to all areas of the operation including review of files and meeting minutes for completeness, accuracy and consistency. Further, this staff member will work with other IRB officers of administration and staff to ensure uniformity of review and compliance with IRB standard operating procedures and applicable federal and state regulations. The IRB Specialist will also serve on relevant IRB administrative committees, such as the Policy Committee and the Education and Training Committee. In addition, this candidate will maintain up to date knowledge of state and federal regulations as well as policies, guidelines and ethical codes related to the protection of human subjects in research. Other work as assigned, which may include but is not limited to special projects or assisting a team other than the one to which the individual is assigned.
Requires a bachelor's degree or equivalent in education and experience, plus three years of related experience of which two years should be of prior IRB and/or research experience.
Familiarity with state and federal regulations related to human subjects protection required. Strong interpersonal and writing skills and experience with computerized databases and word processing is essential.
Experience with biomedical or behavioral and social sciences human research is preferred. Knowledge of international ethical codes and regulations governing human subjects is preferred. Certification as an IRB professional is also preferred.