IRB Analyst

The Human Research Protection Program (HRPP) seeks a dedicated and detail-oriented individual to join our team as an IRB Analyst. The level of appointment (IRB Analyst I or IRB Analyst II) will be determined based on the candidate's experience and qualifications. Both the core responsibilities common to both positions and the additional responsibilities and qualifications required of IRB Analyst IIs are listed below.

IRB Analysts process submissions according to the policies and procedures outlined in the HRPP Toolkit and serves as a regulatory resource to support IRB review. Their primary responsibilities include moving submissions through the office workflow in a timely manner, ensuring that submissions are review ready prior to routing for review, conducting certain non-committee reviews, and generating correspondence after the review process is complete. IRB Analysts are also responsible for coordinating the activities of IRB panels.

IRB Analysts use 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. They also serve as a member/alternate on the IRB and are regulatory specialists designated to conduct certain expedited IRB reviews of research involving human subjects. IRB Analysts identify potential regulatory issues within proposals, and provide technical support, facilitation, procedural guidance, and procedural interaction with human research reviewers and investigators on regulatory and pre-review processing matters.

Position Duties and Responsibilities

Support of Daily IRB Operations (50%)
Adhere to and accurately apply the UMN HRPP Toolkit, which includes local and federal regulations, guidelines, and ethical principles.
Process scientific assessment submissions, including routing to scientific reviewers and ensuring timely completion, communicating review feedback to investigators, and returning any follow-up communications or revisions as appropriate.
Process submissions such as New Studies, Modifications, Continuing Review, and Reports of New Information.
Conduct pre-review to ensure submissions are review-ready.
Process and review reliance/sIRB related submissions.
Provide initial feedback to investigators regarding submission completeness and compliance.
Route submissions for either non-committee or committee review and track expedited reviews.
Communicate review results to investigators and compose detailed correspondence to ensure committee concerns and rationale are clear.
Evaluate investigator's responses to identify potential issues for research reviewers.
Escalate concerns to the IRB Assistant Director and/or Senior Analyst as appropriate.

IRB Panel Coordination and Regulatory Support (20%)
Perform duties as specified in the UMN HRPP Toolkit while meeting efficiency goals set by department
Set agendas and prepare submissions for review by the convened IRB.
Assign reviewers to submissions and manage IRB meeting agendas.
Confirm IRB member attendance to ensure quorum and monitor quorum during meetings.
Document IRB determinations made by the convened IRB
Generate meeting minutes and correspondence.
Review submissions to anticipate regulatory issues for IRB members (e.g., IND/IDE questions)

Designated Review Responsibilities (15%)
Conduct non-committee reviews for certain submissions.
Route submissions appropriately when unable to conduct non-committee reviews due to time constraints or subject matter knowledge.

IRB Support for Research Community (10%)
Provide customer service that meets the mission and facilitates understanding of compliance requirements.
Communicate and consult with investigators and their designees related to human research protocol matters.

Other Duties as Assigned (5%)
Assist with additional tasks as directed by IRB leadership.

Additional Responsibilities for IRB Analyst II:
Independently process submissions with minimal supervision.
Interpret and apply regulations to complex submissions and seek expert consultation as needed.
Provide support during ETHOS upgrades and user acceptance testing.
Serve as a resource to IRB Analyst I to facilitate ongoing training and quality improvement.
Mentor IRB Analyst I during IRB meetings and in performing daily duties.
Provide expert regulatory guidance to IRB Chair and members.
Participate in education and training activities as requested by department leadership.

The Research and Innovation Office (RIO) and the Human Research Protection Program 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 four. Profile four is expected to work fully remotely with the exception of required attendance for on-site events. Your dedicated work space will be in your remote work location. HRPP's management retains the right to modify flexible work arrangement agreements on a temporary or permanent basis for any reason at any time.

IRB Analyst I

Required Qualifications
BA/BS degree with at least two years of professional work experience or a combination of related education and work experience to equal six years.

Preferred Qualifications
Certified IRB Professional (CIP)

IRB Analyst II

Required Qualifications
BA/BS degree with at least two years of direct IRB experience, or a combination of related education and work experience to equal six years
Demonstrated ability to take on additional responsibilities both independently and accurately.

Preferred Qualifications
CIP certification or 15 years of relevant IRB experience

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: $62,000 - $68,000 depending on education/qualifications/experience

Time Appointment: 75%-100% Appointment

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. Both documents should be provided.

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).