| The Senior IRB Analyst is responsible for using the HRPP Toolkit which serves as the institutional warehouse for all policies, guidelines, checklists, worksheets and procedures related to the conduct of human research at the University of Minnesota. Senior IRB Analysts may have a specialized or dedicated role to provide lead support in certain areas of expertise or need (e.g., Toolkit management, Education and Training, sIRB/Reliance, Regulatory Support, and IRB QA Performance). Senior IRB Analyst are expected to have the ability to support other Senior IRB Analysts when needed to facilitate the management and function of the IRB. The Senior IRB Analyst also serves as a member/alternate on the IRB and is a regulatory specialist designated to conduct certain expedited IRB reviews of research involving human subjects. General Responsibilities: Daily IRB Operations, IRB reviews, and IRB Panel Coordination 35% â— Independently triage and process submissions to the HRPP Office as assigned, including New Studies, Modifications (changes in protocol), Continuing Review, and Reports of New Information (Report Form submissions) to include:
o Conduct pre-review to ensure that submissions are review ready. Provide initial feedback to investigators regarding submission completeness, compliance with appropriate regulations, IRB guidelines and institutional policies.
o Route submissions appropriately for either non-committee or committee review. Assign and track reviews from designated reviewers.
o Develop or support the creation of concise and detailed IRB review results to investigators and others as needed to ensure that committee concerns, questions, and rationale are appropriately communicated to researchers; evaluates investigator’s response to identify potential issues for research reviewers.
o Serve as a liaison between the Assistant Directors and IRB Analyst I/IIs.
o Escalate items of concern to the IRB leadership, including providing potential solutions to resolve the issue(s), as appropriate. Contribute to ongoing management of these issues, including consideration of recommendations for any adverse trends.
â— May assign or re-assign submissions to other analysts to ensure efficient, timely processing, and review.
â— Communicates routinely with IRB leadership regarding individual and team performance and, when necessary, recommends corrective actions/interventions. This includes managing team workload, monitoring team productivity and processing turnaround times.
â— Attends IRB meetings to provide regulatory guidance and administrative support. IRB Support and Development 25% â— Communicate and consult with investigators or their designees related to human research protocol matters.
â— Act as a primary resource/mentor to IRB Analyst I/IIs staff during onboarding and training.
â— Provide support to IRB Analyst I/IIs and IRB leaders in areas related to productivity as well as during activities related to adherence to the HRPP mission and department goals.
â— Conducts daily meetings with IRB staff to facilitate efficient processing in accord with departmental goals.
â— Provide direct support to IRB leadership on complex regulatory matters
â— Provide expert support to IRB Analyst I/IIs to ensure consistency in decision making and application of toolkit (e.g. create job aides, new staff onboarding, mentoring etc.).
â— Promote use of the IRB Toolkit and adherence to the HRPP mission.
â— Attend meetings as needed with other University entities to collaborate and to address human subject protection issues
â— Act as an expert IRB resource to the community, IRB Analysts, and IRB Management.
â— Seeks opportunities for professional development to enhance regulatory and institutional expertise.
â— Conduct member training at Biomedical and Social/Behavioral IRB meetings.
â— Participate in the development and conduct of training on IRB-related issues for HRPP staff and IRB members.
â— Act as a primary resource/mentor to IRB Analysts staff during onboarding and training. Lead support in certain areas of expertise or need:
In addition to their general responsibilities, senior IRB analysts may have a specialized or dedicated role to provide lead support in certain areas of expertise or need (e.g., Toolkit management, Education and Training, sIRB/Reliance, Regulatory Support, and IRB QA Performance). Information about the specialty work and approximate percent of time is included but may vary below: Single IRB and Reliance – 35% â— Provide lead support for reliance and sIRB processes, including communicating institutional requirements and other requirements (e.g., State law) to the IRB of record when relying upon an external IRB or utilization of UMN IRB as the sIRB, addressing issues that arise related to external IRB oversight or sIRB oversight, and facilitating the review of sIRB submissions.
â— Performing review of new IRB reliance agreements, where there is not an existing Master Agreement
â— Engaging the Executive Director, Assistant IRB Director, and the Office of General Counsel, as appropriate, to assist with the review of reliance agreements and associate documents.
â— Oversee continuous quality improvement of sIRB and reliance processes and identify opportunities for improvement. Other Projects 5% â— Participate in additional projects, as assigned
â— Coordinate, conduct, and track HRPP training records Salary Range: The typical starting salary for this postion is between $60,000 - $65,000, depending on qualifacations and experience. |
