IRB Specialist

Position Summary

The IRB Specialist of the Columbia University Human Research Protection Office (HRPO) reports to an IRB Senior Specialist-Manager. The IRB Specialist, working collaboratively with a team of other professionals, is primarily responsible for ensuring research protocols submitted for IRB review are assessed in an efficient manner for completeness, accuracy, and level of review according to applicable regulation and/or institutional policy; ensuring regulatory support is provided to a CU IRB with a large portfolio of research; coordinating convened, bi-weekly IRB meetings for review of research, as applicable; serving a resource for the CU research community, IRB Chairs and Members and the HRPO.

Responsibilities

• Review protocol-specific events submitted to the IRB: Perform a detailed, independent regulatory and administrative review, document submission-specific findings, identify regulatory items for reviewers, and advise as to whether the requirements for IRB approval have been met; Generate notifications to researchers regarding the outcome of the review; Evaluate researchers’ responses to IRB requests.
• Work with other HRPO officers of administration to ensure uniformity of review and compliance with IRB standard operating procedures, applicable policies, and applicable federal, state and local statutes.
• Maintain and further develop personal knowledge about applicable statutes, policies and procedures governing human subject research and related ethical codes and guidelines; continuously interpret and apply these requirements to IRB submissions and ongoing research activities.
• Notify designated HRPO staff when guidance and/or policies require updating, including identification of policy/guidance gaps.
• Participate in HRPO-led as well as self-motivated continuing education initiatives.
• If supporting a CU IRB that holds convened meetings, additional responsibilities include: Manage pre-, intra- and post-meeting activities in partnership with the respective Manager and IRB Chair, including agenda management, meeting facilitation and all aspects of IRB meeting documentation; Provide technical support and guidance on regulatory matters during convened IRB meetings.

Duties common to all IRB Specialists: Serve on committees constituted to improve the functioning of the HRPO. Maintain awareness of institutional entities, policies, and relationships that affect HRPO and IRB operations. Develop positive relationships with researchers and colleagues throughout CU to facilitate greater efficiency of HRPO and IRB processes. Other work as assigned.