Advertised Summary Job Description: The Institutional Review Board (IRB) Regulatory Specialist reports to the Director for Operations ("DO") of the Human Research Protection Office (the "HRPO") at Columbia University ("CU"). For tasks related to a specific CU IRB, the IRB Regulatory Specialist may report on a temporary basis to the Director for IRB Management, Assistant Director for IRB Management, or the Manager of that IRB.
The HRPO is responsible for providing administrative and regulatory support to the CU IRBs in the review and oversight of research that involves human subjects. The IRB Regulatory Specialist will provide regulatory support to the HRPO and IRBs in areas that include but are not limited to: - Research on state laws or other regulatory requirements that pertain to research involving human subjects or IRB review of such research and provide recommendations where appropriate. - Working with the DO and CIRB Liaison to review reliance requests and to communicate CU policies and procedures to institutions that may cede IRB review to CU or to which CU may cede IRB review. - Providing assistance in the development, revision, and maintenance of policies and guidance. - Providing assistance with maintaining CU's HRPP accreditation, including preparation or maintenance of accreditation documents. - Other work as assigned, which may include but is not limited to special projects, conducting pre reviews of submissions to the CU IRBs, attendance at IRB meetings, and writing and editing of meeting minutes.
Additionally, the IRB Regulatory Specialist will 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.
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.
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.
Additional Specific Minimum Qualifications: Ability to work independently and collaboratively
Excellent verbal and written communication skills
Excellent interpersonal and presentation skills
Strong computer skills, including Microsoft Office (Word, Excel, PowerPoint)
Preferred Qualifications: Experience with biomedical or behavioral and social sciences human research; knowledge of international ethical codes and regulations governing research with 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.
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.