Clinical Research Coordinator II - Pediatric Child Health Research Institute
About The Position
The Clinical Research Coordinator II must be able to perform the following essential functions independently. This role serves as a study coordinator for clinical trial protocols as assigned, involving activities such as recruiting, screening, enrolling, and consenting study participants. The coordinator will also manage study finances, provide protocol-specific training, and oversee all aspects of study conduct, including data and source documentation, adverse event reporting, and communication with the IRB. Additionally, the role involves managing clinical trial regulatory compliance, maintaining regulatory files, preparing and submitting documents to internal and external organizations, and ensuring the integrity and quality of clinical research trials according to Good Clinical Practice guidelines. Miscellaneous activities include completing assigned tasks, satisfying annual competencies, and participating in professional development and continuing education.
Requirements
- Bachelor's degree in an appropriate area and two years of relevant experience; or an equivalent combination of education and experience.
Nice To Haves
- 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
Responsibilities
- Serve as study coordinator for clinical trial protocols as assigned
- Recruit, screen, enroll, and consent study participants
- Coordinate pre-study and site initiation visits
- Manage study finances, including assisting with study budgets and resolving study subject billing issues
- Provide protocol-specific training of research and clinical staff
- Coordinate all aspects of study conduct, including data and source documentation, adverse event reporting, and communication with the IRB
- Coordinate patient visits in accordance with protocol
- Coordinate site monitor visits
- Submit necessary compliance paperwork
- Ensure billing compliance
- Resolve issues/questions with sponsor
- Serve as the liaison between the Principal Investigator and study subjects
- Perform study feasibility
- Initiate and maintain a current regulatory file
- Prepare and submit documents related to clinical trials to both internal and external organizations
- Complete end of study procedures
- Schedule and participate in sponsored research monitoring visits
- Assure 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
- Attend UF-IRB 01 full board meetings as necessary
- Complete tasks as assigned to complete clinical trial(s)
- Satisfy annual competencies as required by the University of Florida and Institutional Review boards
- Participate in professional development and continuing education
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
