Job Description :
The Clinical Research Coordinator II position will join a team of coordinators that focuses on inherited muscular diseases.
The Clinical Research Coordinator II will coordinate assigned clinical research activities under moderate supervision while simultaneously working as part of the group mentioned above.
The Clinical Research Coordinator II must able to perform the following essential funds independently :
- 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 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.
Advertised Salary :
$, - $,; commensurate with qualifications and experience.
Minimum Requirements :
Bachelor's degree in an appropriate area and two years of relevant experience; or an equivalent combination of education and experience.
Preferred Qualifications :
Understanding of regulatory compliance as it relates to conducting the Study at UF.
Direct contact with patients in a clinical setting
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