Sr. IRB Regulatory Analyst in Coral Gables, FL for University of Miami- Human Subject Research Office

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Sr. IRB Regulatory Analyst
University of Miami- Human Subject Research Office
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Details

Posted: 06-Oct-21

Location: Coral Gables, Florida

Type: Full Time

Required Education: 4 Year Degree

Salary: Competitive

Sector:

College / University

Internal Number: R100051544

About University of Miami- Human Subject Research Office
The Human Subject Research Office (HSRO) provides administrative support for the Institutional Review Boards (IRB) and assists the IRB in its mission to protect human subjects who participate in research. The Senior IRB Regulatory Analyst independently reviews and analyzes scientific and technical components of human subjects' research (HSR) protocols; ensures proposed research is reviewed at the correct level of review and in compliance with federal, state and University mandated laws, regulations, policies and procedures related to HSR protections. The Senior IRB Regulatory Analyst independently makes determinations required for research reviewed under the Expedited process; manages the privileged and confidential institutional review and approval process of all proposed HSR activities involving to protect their safety, rights and welfare. The Senior IRB Regulatory Analyst provides analytical and administrative support to the IRB Committees by conducting review and analysis of every submission the Committee will review and applying regulations, state law, official guidance and University of Miami policies to determine gaps between the proposed research and applicable l...aw and SOPs; makes recommendations based on experience and knowledge and works with investigators, Committee Members and others to resolve issues identified during analysis in a time sensitive manner. The Senior IRB Regulatory Analyst efficiently coordinates and manages IRB Committee meetings. In addition, the Senior IRB Regulatory Analyst supervises, coaches and mentors IRB Regulatory Analysts and Specialists in the activities they conduct during pre-review and review of protocol and providing support for the full IRB Committees.
Connections working at University of Miami- Human Subject Research Office
https://jobboard.bmes.org/jobs/15567143/sr-irb-regulatory-analyst
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