The IRB Analyst is 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 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 is also responsible for coordinating the activities of IRB panels.
The 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. The 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. The IRB Analyst serves a liaison within and between the IRB committees, investigators and their designs. 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.
Job Responsibilities: 1. Support of Daily IRB Operations 50% Comply 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 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. 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 Research Compliance Supervisor as appropriate
2. IRB Panel Coordination and Regulatory Support 30% Perform duties as specified in the UMN HRPP Toolkit 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 Provide regulatory guidance to the IRB Chair and members Review submissions in order to anticipate regulatory issues for which IRB members may need assistance (e.g., IND/IDE questions)
3. Designated Review Responsibilities 10% Conduct non-committee review for certain submissions to be determined by HRPP Office management In cases where the IRB Analyst is unable to conduct non-committee review due to time constraints or subject matter knowledge limitations, route submissions appropriately for non-committee review
4. Liaison for Research Community 10% Function as a liaison within and between the IRB panels, investigators and their designees, and Research Compliance and research administrative staff Communicate and consult with investigators or their designees related to human research protocol matters
Required Qualifications (Must be documented on application materials):
BA/BS with at least 2 years of experience or a combination of related education and work experience to equal six years.
Clinical Research Coordinator Experience
Certified IRB Professional (CIP) and IRB experience.
Additional Salary Information: Salary commensurate with experience. Candidates with clinical research coordination experience preferred.
Internal Number: 330180
About University of Minneasota
The University of Minnesota, Twin Cities, 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.
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.