Senior IRB Analyst

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 and process management, Education and Training, sIRB/Reliance, Regulatory Support, and IRB QA Performance). The Senior IRB Analyst is 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 and/or to support an IRB panel.

Position Duties and Responsibilities

Daily IRB Operations, IRB reviews, and IRB Panel Coordination 30%

• 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:
  • 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.
  • Route submissions appropriately for either non-committee or committee review. Assign and track reviews from designated reviewers.
  • 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.
  • Serve as a liaison between the Assistant Directors and IRB Analyst I/IIs.
  • 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.
• May be assigned to support an IRB committee as the regulatory expert.
• May assign or re-assign submissions to other analysts to ensure efficient, timely processing and review.
• 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.
• Attends IRB meetings to provide regulatory guidance and administrative support.

IRB Support and Development 25%

• Communicate and consult with investigators or their designees related to human research protocol matters.
• Act as a primary resource/mentor to IRB Analyst I/IIs staff during onboarding and training.
• 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.
• Conducts daily meetings with IRB staff to facilitate efficient processing in accord with departmental goals.
• Provide direct support to IRB leadership on complex regulatory matters
• 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.)
• Promote use of the IRB Toolkit and adherence to the HRPP mission.
• Attend meetings as needed with other University entities to collaborate and to address human subject protection issues
• Act as an expert IRB resource to the community, IRB Analysts, and IRB Management.
• Seeks opportunities for professional development to enhance regulatory and institutional expertise
• Conduct member training at Biomedical and Social/Behavioral IRB meetings.
• Participate in the development and conduct of training on IRB-related issues for HRPP staff and IRB members.
• 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). Approximate percent of time is included but may vary.

Process and Change Management - 20%

• Gather from staff and/or provide independent input to HRPP leadership for the ongoing maintenance and improvement of IRB processes.
• Identifies areas of opportunity for process improvement that are aligned with HRPP goals
• Engages reporting and analytics staff to support process and change management.
• Develops an evaluation plan for changes to monitor outcomes.
• Develop, coordinate, and/or facilitate training activities related to process changes/improvements.
• Solicit and incorporate feedback regarding process improvements/changes.

Toolkit Management Support - 20%

• Assist the Assistant IRB Director with the coordination of the quarterly Toolkit Feedback meetings
• Provide support and expertise to IRB leadership and IRB Analyst I/IIs during implementation of IRB toolkit changes and/or initiatives
• Coordinate the development and delivery of trainings associated with Toolkit updates.
• Assist the Assistant IRB Director with management of the Toolkit including revision maintenance, annual audit of the database, and version control

Other Projects 5%

• Participate in additional projects, as assigned

Flexible Work Profile

The Research and Innovation Office (RIO) and the Human Research Protection Program (HRPP) endorses a "work with flexibility" approach that offers a welcoming and flexible work environment where everyone is inspired to do their best. Work location options include working fully remote, partially remote, or entirely in the office and are based on the work of the position. Some on-site work may be necessary for certain positions, even those designated as fully remote.

This position has been designated as eligible for flexible work profile 4.
Profile 4, Fully Remote - Only occasionally visiting the office. Typically spends 4 or less days per month working in the office/lab on average. Your dedicated office space will be in your remote work location.

HRPP management retains the right to modify flexible work arrangement agreements on a temporary or permanent basis for any reason at any time.

Required Qualifications
BA/BS degree plus at least four years of IRB experience or a combination of related education and work experience to equal eight years

Preferred Qualifications
Certified IRB Professional or similar credential
Completion of graduate degree

The mission of the University of Minnesota is deeply connected to the conduct of research. It is of critical importance to the reputation and future of this institution that we remain committed to the highest standards of research integrity in all work conducted in our institution.

The Human Research Protection Program (HRPP) provides support to the Institutional Review Board (IRB). Committee members and staff review all human subjects research conducted by University faculty, staff and students. HRPP also provides support to the research community to ensure ethical standards are met and that research complies with federal, state, local and University of Minnesota regulations.

The IRB reviews human subjects' research projects, working with investigators to ensure adequate protection and informed, uncoerced consent.

Pay Range: $74,484.80 ($35.81 per hour) - $81,328.00 ($39.10 per hour); depending on education/qualifications/experience

Position Type: Civil-Service & Non-Faculty Labor Represented Staff

Please visit the Office of Human Resources website for more information regarding benefit eligibility.

The University offers a comprehensive benefits package that includes:

• Competitive wages, paid holidays, and generous time off
• Continuous learning opportunities through professional training and degree-seeking programs supported by the Regents Tuition Benefit Program
• Low-cost medical, dental, and pharmacy plans
• Healthcare and dependent care flexible spending accounts
• University HSA contributions
• Disability and employer-paid life insurance
• Employee wellbeing program
• Excellent retirement plans with employer contribution
• Public Service Loan Forgiveness (PSLF) opportunity
• Financial counseling services
• Employee Assistance Program with eight sessions of counseling at no cost
• Employee Transit Pass with free or reduced rates in the Twin Cities metro area

Applications must be submitted online. To be considered for this position, please click the Apply button and follow the instructions. You will be given the opportunity to complete an online application for the position and attach a cover letter and resume.

Additional documents may be attached after application by accessing your "My Job Applications" page and uploading documents in the "My Cover Letters and Attachments" section.

To request an accommodation during the application process, please e-mail employ@umn.edu or call (612) 624-8647.

The University recognizes and values the importance of diversity and inclusion in enriching the employment experience of its employees and in supporting the academic mission. The University is committed to attracting and retaining employees with varying identities and backgrounds.

The University of Minnesota provides equal access to and opportunity in its programs, facilities, and employment without regard to race, color, creed, religion, national origin, gender, age, marital status, disability, public assistance status, veteran status, sexual orientation, gender identity, or gender expression. To learn more about diversity at the U: http://diversity.umn.edu

Any offer of employment is contingent upon the successful completion of a background check. Our presumption is that prospective employees are eligible to work here. Criminal convictions do not automatically disqualify finalists from employment.

The University of Minnesota, Twin Cities (UMTC)

The University of Minnesota, Twin Cities (UMTC), is among the largest public research universities in the country, offering undergraduate, graduate, and professional students a multitude of opportunities for study and research. Located at the heart of one of the nation's most vibrant, diverse metropolitan communities, students on the campuses in Minneapolis and St. Paul benefit from extensive partnerships with world-renowned health centers, international corporations, government agencies, and arts, nonprofit, and public service organizations.

At the University of Minnesota, we are proud to be recognized by the Star Tribune as a Top Workplace for 2021, as well as by Forbes as Best Employers for Women and one of America's Best Employers (2015, 2018, 2019, 2023), Best Employer for Diversity (2019, 2020), Best Employer for New Grads (2018, 2019), and Best Employer by State (2019, 2022).