Research Regulatory Analyst II

University Of Florida Gainesville , FL 32601

Posted 1 week ago

Classification Title:

Rsch Regulatory Analyst II

Job Description:

Non-Full Board Related Duties:

  • On the basis of IRB Executive reviewers' comments in myIRB, accurately generate letters to the principal investigators that report the results of the IRB Expedited review. This includes 'needs reply', 'approved with contingencies', suspensions, and other letters.

  • Generate some letters of approval and serve as a back-up for other IRB office staff as needed.

  • Assist faculty and research staff with IRB questions, including assisting in navigating myIRB, resolving review related problems and/or errors.

  • Evaluate certain types of IRB submissions.

  • If appointed as an office board member/contingency approver, approve contingencies in accordance with office guidelines.

  • Assist in revising/creating office documents as needed.

Full Board Meeting Functions Include:

  • During Full Board meetings take notes into a minutes template. The minutes must accurately reflect all discussions, both directly related to specific protocols and inclusive of all relevant issues that were discussed and any decisions that were made. Minutes must meet Federal regulatory/AAHRPP requirements which are built into the template.

  • On the basis of reviewer notes/minutes, accurately compose and generate letters to the principal investors that report the results of the IRB Full Board review and instruct them when changes are required.

  • Work with the IRB Chair to trouble shoot issues and note completion after the meeting.

  • Prepare past Full Board finalized minutes for the Board approval.

Board Meeting preparation functions include:

  • Analyze and evaluate proposals to ensure that proposals meet agency, federal, state, and university guidelines in preparation for Committee review.

  • Review agenda items, board member attendance and prepare template language for minutes.

Other duties as assigned


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