Incumbent will coordinate research studies with minimal supervision or as part of an assigned team. Incumbent will perform all Clinical Research Coordinator (CRC) Core responsibilities as well as additional responsibilities detailed below for Clinical Research Coordinator II. Assignments for this position include large scale data extraction from electronic medical records, data entry, and IRB compliance. Incumbent will manage projects according to established deadlines, maintain accurate and timely records, maintain consistent communication and assist with the development of manuscripts, grants, protocols and educational materials as needed.
Perform detailed chart review, review of inclusion/exclusion criteria, input data into Sponsor and/or internal database(s), resolve data queries in a timely fashion, and assist with data clean up and analysis on specific projects as needed.
Maintain consistent communication at regular/frequent intervals with PI and study team, maintain regulatory binders and patient binders as applicable, maintain good working relationships with study staff and Sponsor/Government Agency representatives, assist with monitor/auditor visits, and assist with grant-required progress reports.
Complete required trainings on protocols as directed, work on special projects as needed, conduct literature reviews, and create bibliographies as needed.
Assist with writing, editing, and/or submitting IRBs for new projects and ensure IRB compliance for current projects.
Miscellaneous Activities – Activities include but are not limited to: completing tasks assigned to complete human subjects research; Satisfying annual competencies as required by the University of Florida and Institutional Review boards; participating in professional development and continuing education.
