CASY-MSCCN Jobs

• 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

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