
Job Information
Columbia University Senior IRB Specialist (Senior Manager) in New York, New York
Requisition no: 513775
Work Type: Full Time
Location: Campus|Morningside,Campus|Medical Center
School/Department: null
Categories: Research (Lab and Non-Lab),General Administration,Health/Clinical
Job Type: Officer of Administration
Bargaining Unit:
Regular/Temporary: Regular
End Date if Temporary:
Hours Per Week: 35
Salary Range:
Position Summary
The Senior IRB Specialist- Senior Manager of the Institutional Review Board (IRB)/Manager, reports to the Director or Assistant Director for IRB Management of the Human Research Protection Office (HRPO).
The Senior IRB Specialist- Senior Manager, working collaboratively with a team of other professionals, is primarily responsible for managing one or more CU IRBs with a large portfolio of research to oversee team functionality; provide regulatory guidance and support to IRB members; serve as a resource for the CU research community, including education efforts; develop HRPO Staff; serve a key role in identifying gaps in policy and guidance documents; and provide input to improve the effectiveness and efficiency of the HRPO.
Responsibilities
Core responsibilities
Manage a large volume of research protocols and related submissions, from assignment through IRB approval, and ensure high level of quality and uniformity of review of these protocols;
Lead the designated IRB team to meet HRPO’s expectation for quality, productivity and goal accomplishment; encourage IRB specialist contribution and provide feedback;
Review protocol-specific events submitted to the IRB
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;
Participate in HRPO-led as well as self-motivated continuing education initiatives
Conduct quality control functions; this may extend to all areas of the operation including review of files and meeting minutes for completeness, accuracy and consistency;
Ensure the accuracy of the records generated by the administrative team, Chair and IRB reviewers.Draft, edit and issue approval letters to PIs;
Apply strong organizational skills and effective teamwork skills to assist in management of a large volume of submissions, deadlines, and customer expectations;
Assist with policy and guidance revision;
Oversee team functionality:
Ensure 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
Lead the designated IRB team to meet HRPO’s expectation for quality, productivity and goal accomplishment; encourage IRB specialist contribution and provide feedback.
Ensure the accuracy of the records generated by the administrative team, Chair and IRB reviewers
Maintain basic records of direct report
Provide feedback to the Assistant Director regarding team performance, need for personnel, procedural changes and IRB issues.
Provide regulatory guidance and support to IRB members:
Participate in the evaluation of the IRB Chairs and members
Train new IRB members on how to use the CU electronic review system and facilitate onboarding.
Serve as a voting member of the IRB they support and other CU IRBs as needed
Conduct IRB member orientation session as necessary
Serve as a resource for the CU research community:
- Conduct training sessions/Rascal workshops for Research Community as per pre-determined schedule
Develop HRPO Staff:
Supervise and train direct report(s) in accordance with HRPO’s policies and procedures and in accordance with the core educational program that is required for research personnel.
Evaluate performance of direct report(s) at least annually
Work with supervisor and other managers to recruit, interview and select IRB specialists or senior IRB specialists.
Conduct training sessions on review processes for HRPO staff as per pre-determined schedule
If responsible for supporting a CU IRB that process protocols to be reviewed by the convened IRB:
Manage pre-, intra- and post-meeting activities in partnership with the respective IRB Chair and other ancillary review committees when applicable; Including agenda management, meeting facilitation and all aspects of IRB minutes documentation; Provide lead regulatory expertise during convened meetings
Ensure that IRB meeting minutes are in compliance with federal regulatory standards and institutional requirements
Duties common to all Senior IRB Specialists:
Significant involvement in one or more internal committees constituted to improve the functioning of the HRPO.
Serve a significant role in the testing of electronic submission system updates
Maintain awareness of institutional entities, policies, and relationships that affect HRPO and IRB operations and disseminate new information office wide.
Develop positive relationships with researchers and colleagues throughout CU to facilitate compliance and greater efficiency of HRPO and IRB processes.
Other work as assigned, including coverage for colleagues during vacation or during vacancies.
Core competencies necessary for success:
Client Focus
Strategic Decision-Making
Initiating Action
Focusing on results
Sets high standards of performance for self and others.
Minimum Qualifications
- Bachelor's degree or equivalent in education and experience plus four years of related experience. Strong institutional Review Board (IRB) knowledge and IRB protocol and regulatory experience.
Preferred Qualifications
- Previous higher education IRB experience
Other Requirements
Core competencies necessary for success:
Client Focus
Strategic Decision-Making
Initiating Action
Focusing on results
Sets high standards of performance for self and others.
Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.
Columbia University
-
- Columbia University Jobs