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Clinical Research Coordinator II - Pediatrics Child Health Research Institute
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.
$53000 - $60500; commensurate with qualifications and experience.
Bachelors degree in an appropriate area and two years of relevant experience; or an equivalent combination of education and experience.
Understanding of regulatory compliance as it relates to conducting the Study at UF.
Direct contact with patients in a clinical setting. Knowledge of accepted procedures and ethical confidential practices. Excellent interpersonal skills: ability to work independently solve problems and make appropriate decisions. Ability to communicate effectively both verbally and in writing. Proficiency in all Microsoft Office applications. Ability to demonstrate thoroughness and accuracy when accomplishing a task. Strong organizational skills. Ability to adapt to change. The ability to respond to situations in an appropriate / professional manner. The ability to effectively manage multiple activities accurately. The ability to work and thrive in a team environment.
To be considered for this position please upload a copy of your cover letter or letter of interest resume and a list of 3 professional references.
The University of Florida is committed to providing equal employment opportunities for all qualified individuals. If you require an accommodation due to a disability to apply for this position please contact the ADA Office at or the Florida Relay System at (TDD). For more information visit the UF ADA Compliance website:
Normal work hours are 8:00am to 5:00pm Monday through Friday.
This is a time limited position.
Application must be submitted by 11:55 p.m. (ET) of the posting end date.
Required Experience:
IC
Full-Time