University of Florida QA Admin Supplement Project Summary In February 2016, NCATS provided guidance regarding the need for CTSA grantees to seek prior approval for all pilot and KL2 and TL1 scholar projects involving human subjects. In order to be in compliance with this requirement, the intent of this funding request is in response to the NCATS program need for a dedicated quality assurance/quality control position to perform quality reviews of CTSA-related submissions to NCATS in the eRA Human Subjects System. The requested funding will be in support of a position for quality reviews and management of the overall process.
University of Florida QA Admin Supplement Project Narrative A candidate will be recruited with experience in key project management principles and responsibilities, including concurrently monitoring multiple projects in different stages, and continually seeking process improvements ? deploying Continuous Quality Improvements (CQI) methodologies. The successful candidate will have familiarity with federal and institutional clinical research regulatory requirements and research administration processes and will possess excellent written and verbal communication skills. The candidate will possess solid organizational skills, including attention to detail, and a strong working knowledge of project management applications along with desktop productivity software and data integration tools. The candidate will also have a strong skillset in managing complex projects with multiple stake holders and understand the need to build strong relationships with regulatory and institutional resources.
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