Clinical Research Coordinator I - Pediatrics CHRI

University of Florida • Gainesville, FL

20h

About The Position

The Clinical Research Coordinator I position described herein 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. Activities include 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; and 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.

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
• Prior experience working with inherited muscular diseases

Responsibilities

• Coordinate clinical research studies, including recruiting patients, coordinating patient visits according to protocol, managing site monitor visits, submitting compliance paperwork, ensuring billing compliance, resolving sponsor issues, serving as liaison between PI and study subjects, and performing study feasibility assessments.
• Manage clinical trial regulatory compliance, including initiating and maintaining regulatory files, preparing and submitting documents to internal and external organizations, completing end of study procedures, scheduling and participating in sponsored research monitoring visits, assuring trial integrity and quality according to Good Clinical Practice guidelines, and attending UF-IRB 01 full board meetings.
• Assist senior team members on more complex clinical research studies, including assisting the research manager and other team members with regulatory submissions.
• Complete assigned tasks to finalize clinical trials.
• Satisfy annual competencies as required by the University of Florida and Institutional Review boards.
• Participate in professional development and continuing education.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree