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The Clinical Research Coordinator I position described herein will coordinate simple clinical research
studies and assist in the coordinator of complex clinical research studies in the Department of Pediatrics,
Child Health Research Institute. All clinical studies will focus on inherited muscular diseases. The
incumbent will be responsible for coordinating all aspects of assigned simple clinical trials and assisting
more experienced coordinators managing complex clinical research studies. Activities include 1.
Onboarding new clinical studies following institutional workflows and requirements; 2. Obtaining and
maintaining regulatory compliance; 3. Verifying study-related charges following institutional and
departmental timelines; 4. Serving as the point of contact for all administrative matters related to assigned
studies; 5. Enrolling patients into assigned clinical studies; 6. Coordinating patient and study monitor site
visits; and 7. Presenting study updates at weekly team meetings.
The Clinical Research Coordinator I position will join a team of coordinators that focuses on inherited
muscular diseases. The Clinical Research Coordinator I will coordinate assigned simple clinical research
studies while simultaneously assisting senior team members on more complex clinical research studies.
The Clinical Research Coordinator I must be able to perform the following essential functions independently:
Coordinate clinical research studies
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 the sponsor; serving
as the liaison between the Principal Investigator and study subjects; performing study feasibility
assessments for potential new studies.
Clinical trial regulatory compliance management for clinical studies managed and assisting.
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-OCR, UF-IBC, etc.) and external
(FDA, RAC,WCG, etc) organizations as required; completing end of study procedures; scheduling and
participating in sponsored research monitoring visits; assuring that the clinical research trial's integrity and
quality are maintained and that the trial is conducted following Good Clinical Practice guidelines; attending
UF-IRB 01 full board meetings as necessary.
Assist senior team members on more complex clinical research studies. Assisting research manager and other team members with regulatory submissions as needed.
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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