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").
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 HRPO also manages IRB reliance (e.g., single and central IRB) situations. The IRB Regulatory Specialist will provide regulatory and administrative support for office-wide initiatives that include but are not limited to the following specific responsibilities.
Working with the DO and the Senior IRB Specialist-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.
Drafting, reviewing for accuracy, assembling and/or maintaining all required documents pertaining to reliance situations, e.g., Reliance Agreements between institutions and service contracts with commercial IRBs.
Providing assistance in the development, revision, and maintenance of HRPO and IRB policies, guidance, and education/training documents.
Providing assistance with the process for reaccreditation of CU's human research protection program.
Managing calls and emails to the HRPO's general phone number and email inbox.
Synthesizing relevant information on federal and state laws or other regulatory requirements that pertain to research involving human subjects, or IRB review of such research, and providing recommendations for CU application, where appropriate.
Duties common to all HRPO Specialists
Serve on relevant IRB administrative committees constituted to improve the functioning of the HRPO, such as the Policy Committee and the Education and Training Committee.
Maintain up to date knowledge of applicable state and federal regulations as well as policies, guidelines and ethical codes related to the protection of human subjects in research.
Develop positive relationships with researchers and colleagues throughout CU to facilitate compliance and greater efficiency of HRPO and IRB processes.
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.
Requires a bachelor's degree or equivalent in education and experience, plus three years of related experience in an IRB and/or research environment
The successful candidate will demonstrate:
Familiarity with state and federal regulations related to human subjects protection;
Strong interpersonal and writing skills, and experience with computerized databases and word processing;
Ability to work independently and collaboratively;
Strong organizational and time management skills;
Ability to make accurate and appropriate independent judgments, including when to escalate issues.
Experience with biomedical, behavioral, and/or social sciences human research;
Knowledge of international ethical codes and regulations governing protection of human subjects in research;
Experience with electronic research administration systems; and
Certification as an IRB professional.
Core competencies necessary for success
Applied Learning - Assimilates and applies job-related information in a timely manner; puts new knowledge, understanding, or skill to practical use on the job.
Stress Tolerance - Maintains stable performance under pressure; stays focused on work tasks and productively uses time and energy when under stress; presents a positive disposition and maintains constructive interpersonal relationships when under stress.
Contributing to Team Success & Collaboration - Actively participates as a member of a team to move the team toward the completion of goals; working effectively and cooperatively with others; establishing and maintaining good working relationships.
Initiating Action - Takes prompt action to accomplish objectives; takes action to achieve goals beyond what is required; is proactive and resourceful.
Communication - Clearly conveys information and ideas through a variety of media to individuals or groups in a manner that engages the audience and helps them understand and retain the message.
Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.
Internal Number: 503053
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.