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Incumbent will coordinate assigned clinical trials and assist the Principal Investigator by communicating with families participating in the study via telephone and in person to gather necessary research information, provide informed consent, and address questions and concerns. Preparing and compiling necessary items for research study appointment and assisting with administration of patient questionnaires and patient exams. Assist Principal Investigator in writing manuscripts, presentations, grants and IRB protocols and assist in data collection, compilation, and analysis for special projects, publications, etc.
Serve as study coordinator for clinical trial protocols as assigned:
Activities include and are not limited to: recruiting patients to enroll in study(ies); 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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