Advertised Summary Job Description: The IRB Specialist of the Columbia University (CU) Human Research Protection Office (HRPO)/Institutional Review Boards (IRB) reports to the Associate/Director of Operations (A/DO) of the HRPO. For tasks related to a specific Columbia University Medical Center (CUMC) IRB, the IRB Specialist may report on a temporary basis to the Manager of that IRB.
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.
General Minimum Qualifications: Requires a bachelor's degree or equivalent in education and experience, plus three years of related experience of which two years should be with IRB and/or research experience.
Additional Specific Minimum Qualifications: 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.
Preferred Qualifications: 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.
As a member of the National Collegiate Athletic Association (NCAA) and the Council of Ivy Group Presidents (Ivy League), it is imperative that members of the Columbia University community, in all matters related to the intercollegiate athletics program, exhibit the highest professional standards and ethical behavior with regard to adherence to NCAA, Conference, University, and Department of Intercollegiate Athletics and Physical Education rules and regulations.
Columbia University is an Equal Opportunity/Affirmative Action employer.
Columbia University is one of the world's most important centers of research and at the same time a distinctive and distinguished learning environment for undergraduates and graduate students in many scholarly and professional fields. The University recognizes the importance of its location in New York City and seeks to link its research and teaching to the vast resources of a great metropolis. It... seeks to attract a diverse and international faculty and student body, to support research and teaching on global issues, and to create academic relationships with many countries and regions. It expects all areas of the university to advance knowledge and learning at the highest level and to convey the products of its efforts to the world.