Advertised Summary Job Description: The Senior IRB Specialist of the Institutional Review Board (IRB)/ Senior Manager, reports to the Assistant Director for IRB Management of the Columbia University Human Research Protection Office (HRPO). This staff member will join other professionals who are responsible for management of the IRB operation.
Specific responsibilities will include management and supervision of staff assigned to provide administrative and regulatory support to one IRB in a manner that will ensure the respective IRB is in compliance with all federal and regulatory requirements and accreditation standards. Additionally, the team must be managed for efficient and high quality performance.
Other responsibilities include: - Ensuring that minutes are in compliance with federal regulatory standards. - Conducting pre-review of submissions to CUMC IRBs. - Providing regular feedback to the Assistant Director regarding team performance, need for personnel, policy, or procedural changes, and IRB issues. - Working closely with the IRB Chair(s) to provide administrative support in the review and processing of submissions. - Ensuring that all correspondence related to the respective IRB is accurate, appropriately formatted, and comprehensive prior to release. - Serving on committees constituted to improve the functioning of the IRB office. - Being aware of institutional entities, policies, and relationships that affect IRB functioning. - Advising investigators to facilitate efficient review of submissions. - Serving as voting member of IRB. - Other work as assigned.
This staff member will also 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 Senior IRB Specialist 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.
General Minimum Qualifications: A bachelor's degree or equivalent, plus four years of related experience, of which at least two years should be of direct IRB experience.
Additional Specific Minimum Qualifications: The Senior IRB Specialist must have up to date knowledge of state and federal regulations and be familiar with policies, guidelines and ethical codes related to the protection of human subjects in research. Strong interpersonal and writing skills, and experience with computerized databases and word processing, are essential.
Preferred Qualifications: Experience with biomedical, behavioral, and social sciences human research, knowledge of international ethical codes and regulations governing human subjects research, and certification as an IRB professional are preferred.
Experience with biomedical, behavioral, and social sciences human research, knowledge of international ethical codes and regulations governing human subjects, and certification as an IRB professional are 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.
Internal Number: 126_169793
About Columbia University
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.