Clinical Research Coordinator I - Pediatrics CHRI
About The Position
The Clinical Research Coordinator I position will coordinate simple clinical research studies and assist in the coordination 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. The Clinical Research Coordinator I 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.
Requirements
- Associate’s degree or an allied health professional degree in an appropriate area and one year of relevant experience; or an equivalent combination of education and experience.
Nice To Haves
- Bachelor's Degree
- Knowledge and experience with clinical trial research process and policies
- Proficiency in all Microsoft Office applications; ability to communicate effectively both verbally and in writing
- Excellent interpersonal skills
- Prior experience of direct patient contact preferred
- Prior experience working with inherited muscular diseases
Responsibilities
- Onboarding new clinical studies following institutional workflows and requirements
- Obtaining and maintaining regulatory compliance
- Verifying study-related charges following institutional and departmental timelines
- Serving as the point of contact for all administrative matters related to assigned studies
- Enrolling patients into assigned clinical studies
- Coordinating patient and study monitor site visits
- Presenting study updates at weekly team meetings
- 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
- 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
- Assisting research manager and other team members with regulatory submissions as needed
- 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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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Associate degree
