The Clinical Research Coordinator II must able to perform the following essential functions independently:
Serve as study coordinator for clinical trial protocols as assigned:
Activities include and are not limited to: recruiting, screening, enrolling and consenting of study participants; coordinate pre study and site initiation visits, manage study finances including assisting with study budget and resolving study subject billing issues, provide protocol specific training of research and clinical staff involved in the study, with minimal assistance / supervision coordinate all aspects of study conduct, including data and source documentation, adverse event reporting, and communication with the IRB, coordinating patient visits; managing patient visits in accordance to protocol; coordinating site monitor visits; submitting necessary compliance paperwork; ensuring billing compliance; resolving issues/questions with sponsor; serving as the liaison between the Principal Investigator and study subjects; perform study feasibility.
Clinical trial regulatory compliance management:
Activities included but are not limited to: initiating and maintaining a current regulatory file; preparing and submitting documents related to clinical trials to both internal (UF-IRB, UF-CTC office, UF-IBC, etc.) and external (FDA, RAC, WIRB, etc.) organizations as required; completing end of study procedures; schedule and participate in sponsored research monitoring visits; assuring that the integrity and quality of the clinical research trial is maintained and that the trial is conducted in accordance with Good Clinical Practice guidelines; attending UF-IRB 01 full board meetings as necessary.
Miscellaneous Activities:
Activities include but are not limited to: completing tasks as assigned to complete clinical trial(s); Satisfying annual competencies as required by the University of Florida and Institutional Review boards; participating in professional development and continuing education.
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