The IRB Analyst I is an entry level position and responsible for processing submissions according to the policies and procedures outlined in the HRPP Toolkit and serves as a regulatory resource to support IRB review. The IRB Analyst I has the primary responsibility of 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. The IRB Analyst I is also responsible for coordinating the activities of IRB panels.
The IRB Analyst I 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. The IRB Analyst I 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. The IRB Analyst I serves a liaison within and between the IRB committees, investigators, and their designees. This requires communicate and consultation with investigators or their designees related to clinical research protocol matters. This position must possess the ability to 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.
The Office of the Vice President for Research (OVPR) and 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 work profile 3. Profile 3 is expected to work remotely more than 50% of the time. 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.
1. Support of Daily IRB Operations - 50%
Adhere to and accurately apply under the supervision and mentorship of more senior members of the IRB team, with the UMN HRPP Toolkit which includes applicable local and federal regulations, rules, guidelines and ethical principles. Perform duties as specified in the UMN HRPP Toolkit. Process scientific assessment submissions as assigned, including routing submissions to scientific reviewers, ensuring reviews are completed in a timely manner as specified, communicating review feedback to investigators, and returning any follow-up communications or revisions as appropriate. 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) Conduct pre-review to ensure that submissions are review ready. Process and review reliance/sIRB related submissions in accordance with the UMN HRPP Toolkit 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. Assigns and tracks reviews from expedited reviewers. Sends reminders to reviewers as needed to ensure review turnaround times are met or exceptions are documented. Communicate review results to investigators and others as needed. Compose clear, concise, and detailed correspondence to investigators to ensure that committee concerns, questions, and rationale are appropriately communicated to researchers; evaluates investigator’s response to identify potential issues for research reviewers. Escalate items of concern to the IRB Assistant Director and/or Senior Analyst as appropriate.
2. IRB Panel Coordination and Regulatory Support - 20%
Perform duties as specified in the UMN HRPP Toolkit under the direct supervision by and mentoring from more senior members of the IRB team to ensure that the meeting adheres the criteria for approval. Prepare submissions for review by the convened IRB Assign reviewers to submissions Manage IRB meeting agenda volume according to established guidelines Confirm IRB member meeting attendance to ensure quorum Monitor quorum during IRB meetings Document determinations made by the convened IRB Generate IRB meeting minutes and correspondence Review submissions in order to anticipate regulatory issues for which IRB members may need assistance (e.g., IND/IDE questions)
3. Designated Review Responsibilities - 15%
Conduct non-committee review under the direct supervision of and mentoring from more senior members of the IRB team for certain submissions to be determined. In cases where the IRB Analyst I is unable to conduct non-committee review due to time constraints or subject matter knowledge limitations, route submissions appropriately for non-committee review.
4. IRB Support for Research Community - 10%
Commit to providing customer service that is consistent with both meeting the mission and facilitating broader understanding of compliance requirements. Communicate and consult with investigators or their designees related to human research protocol matters.
5. Other duties as assigned - 5%
Assist with any other duties as assigned by IRB leadership.
Salary Range: $52,000 - $55,000
BA/BS with at least 2 years of experience or a combination of related education and work experience to equal six years.
The University of Minnesota, founded in the belief that all people are enriched by understanding, is dedicated to the advancement of learning and the search for truth; to the sharing of this knowledge through education for a diverse community; and to the application of this knowledge to benefit the people of the state, the nation, and the world.