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.

Core 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.

IRB Analyst 1

Required Qualifications
BA/BS degree with at least two years of 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.