Biomedical Research Alliance of New York

Institutional Review Board (IRB) Coordinator

Under the supervision of the BRANY IRB Director, legal counsel, and IRB chairs, the incumbent coordinates the efficient operation of the Institutional Review Board.

The coordinator is responsible for:

• Implementing established procedures to process application packets (applications for review, research protocols, and consent forms)
• Providing support to investigators and research coordinators
• Supervising clerical assistance supporting the administrative review and processing of applications to the IRB
• Maintaining official records of the committee’s activities and preparation of meeting materials assuring that applications are complete and accurate prior to committee review
• Assuring timely and appropriate response to adverse event reports
• Serving as liaison between investigators and IRB to obtain the most expeditious, accurate and complete responses to committee questions
• Coordinating IRB meetings
• Attending IRB meetings to provide technical information pertaining to local, state, and federal regulations
• Preparing meeting agendas and minutes
• Participating in training programs for IRB members
• Performing quality assurance reviews for compliance with OHRP/FDA regulations and internal SOPs
• Maintaining and continually refining customized, networked computerized database to allow
• for timely tracking of research projects scheduled for re-review
• Drafting appropriate correspondence to investigators

Minimum Requirements:

• Demonstrated written and oral communications skills.
• Ability to perform multiple tasks with a high level of accuracy and attention to detail.
• Working knowledge of research and medical terminology.
• Demonstrated ability to work independently in a team-oriented environment, followthrough, independently perform against deadlines with frequent interruptions and competing priorities.
• Ability to exercise sound judgment and initiative in collecting technical information from a wide variety of sources; to maintain confidentiality with tact and discretion; to interpret and apply ethical principles.
• Education and experience equivalent to a Bachelor’s degree in biomedical sciences, ethics, public health or related field.
• IRB experience and knowledge of OHRP and FDA regulations is a plus.