Research Regulatory Analyst II - University of Florida

Gainesville, FL

About the Job

This is a highly professional and responsible position, which answers to the Research Regulatory Manager. The incumbent is expected to be knowledgeable about federal, state, and local regulations and rules and apply them in processing IRB Submissions, and in producing IRB Full Board Minutes. The incumbent serves as a communication hub between the IRB-01 Board, Executive Reviewers and the Principle Investigators and their teams.

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
Expected Salary:	$50K to $55K Commensurate with Education and Experience
Minimum Requirements:	Bachelor’s degree in an appropriate area and two years of experience in appropriate area; or an equivalent combination of education and experience.
Preferred Qualifications:	Mastery of Federal, state, and local regulations and rules. Excellent written and oral communication skills. Demonstrated attention to detail. Ability to act as liaison and to use negotiation skills to resolve conflicts with investigators regarding their protocols. Capable writer and editor. Ability to use computer software programs including Zoom.
Special Instructions to Applicants:	This position has been reposted. Previous applicants are still under consideration and need not reapply. In order to be considered, applicants must provide a cover letter, resume, and a list of professional references. A criminal background check is required. This is not a remote work position. Application must be submitted by 11:55 p.m. (ET) of the posting end date.
Health Assessment Required:	No.

Source : University of Florida