IRB Specialist

at  Columbia University

• Job Type: Officer of Administration
• Regular/Temporary: Regular
• Hours Per Week: 35
• Salary Range: $65,000 - $75,0000
  The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University’s good faith and reasonable estimate of the range of possible compensation at the time of posting.
  Position Summary
  The IRB Specialist of the Columbia University Human Research Protection Office (HRPO) has the primary responsibility for providing subject matter expertise in the review of human subject research. The IRB Specialist reports to an IRB Senior Specialist, or a Director within the IRB Management team. 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 one or more Columbia IRBs, each of which have a large portfolio of research; coordinating convened, bi-weekly IRB meetings for review of research, as applicable; and serving as a resource for the Columbia research community, IRB Chairs and Members and the HRPO.
  Responsibilities

Core responsibilities:

• Review protocol-specific events submitted for IRB review:
• 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;
• Recommend the appropriate level of review for assigned research submissions;
• Generate notifications to researchers regarding the outcome of the review;
• Evaluate researchers’ responses to IRB requests;
• Independently apply the framework of applicable federal regulations, laws, guidance, and CU IRB policies and procedures to assigned reviews;
• Advise the research community about human subjects protection issues and institutional policies.
• 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 Columbia 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 HRPO STAFF:

• Serve on committees constituted to improve the functioning and climate 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 olumbia to facilitate compliance and greater efficiency of HRPO and IRB processes.
• Participate in evaluation of enhancements or other modifications to the IRB module of the Columbia research administration system.
• Other work as assigned.

Core responsibilities:

• Review protocol-specific events submitted for IRB review:
• 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;
• Recommend the appropriate level of review for assigned research submissions;
• Generate notifications to researchers regarding the outcome of the review;
• Evaluate researchers’ responses to IRB requests;
• Independently apply the framework of applicable federal regulations, laws, guidance, and CU IRB policies and procedures to assigned reviews;
• Advise the research community about human subjects protection issues and institutional policies.
• 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 Columbia 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