| Job Description: |
The Department of Neurology, Neuromuscular Division at the University of Florida is seeking a candidate who has experience with clinical trials specifically FDA compliance, institutional review board, and NIH funded trials for a Clinical Research Coordinator I position. The Clinical Research Coordinator I is responsible for coordinating and conducting neuromuscular research studies and managing all regulatory aspects of those neuromuscular clinical trials within the Department of Neurology. The Coordinator I will also assist lead coordinators and investigators in clinical trial and database related procedures. The spectrum of the work involves coordination of the participant visits, obtaining consent, recording data, and management of IRB related requirements.
About this Role
Research Administration & Compliance
- Oversee administrative and regulatory aspects of assigned research studies
- Identify, document, and report adverse events, protocol deviations, and non-compliance to the appropriate IRB
- Interpret and apply FDA and IRB regulations to ensure study compliance
- Support investigators in meeting regulatory requirements and maintaining audit readiness
- Maintain accurate regulatory documentation and filing systems for active protocols
- Study Coordination & Communication
- Communicate regularly with principal investigators, lead coordinators, and research staff regarding recruitment, required trainings, and protocol amendments
- Coordinate with study monitors and sponsors for scheduled monitoring visits and data management activities
- Respond to data queries, monitor for data delinquencies, and address sponsor or study-related requests
- Escalate concerns related to protocol deviations and adverse events to the Principal Investigator and lead coordinators
Data & Clinical Trial Tracking
- Update clinical trial management systems and internal tracking logs
- Track participant visits, enrollment activity, and billable services
Program Representation & Sample Management
- Represent the neuromuscular program at research meetings and conferences (approximately 10%)
- Coordinate collection, processing, and shipment of biological samples for assigned trials
- Ensure adherence to safety and quality standards for handling, processing, shipping, and disposal of biological specimens
About the Department of Neurology, Neuromuscular Division at the University of Florida
The Department of Neurology, Neuromuscular Division at the University of Florida is a nationally recognized leader in the diagnosis, treatment, and research of neuromuscular disorders. Led by Dr. James Wymer, the division specializes in conditions such as ALS, myasthenia gravis, muscular dystrophy, and peripheral neuropathies. It offers patients access to cutting-edge clinical trials and emerging therapies through its robust research program. The team takes a multidisciplinary approach, working closely with physical therapists, occupational therapists, and other specialists to provide comprehensive, patient-centered care. Faculty are actively involved in education and training, helping to shape the next generation of neurologists and clinical research professionals. The division also collaborates with national organizations and industry partners to advance the development of new treatments and improve patient outcomes.
To learn more about the Neuromuscular Division at the University of Florida, please visit https://neurology.ufl.edu/divisions/neuromuscular/
We Offer Exceptional Benefits
- Low-cost State Health Plans: Medical, Dental, and Vision Insurance
- Life and Disability Insurance
- Generous Retirement Options to secure your future
- Comprehensive Paid Time Off Packages: (includes over 10 paid holidays, as well as paid family, sick and vacation leave)
Exceptional Personal and Professional Development Opportunities: Access to UF Training & Organizational Development programs, leadership development, LinkedIn Learning, and more
- Tuition Assistance through the UF Employee Education Program
- Public Service Loan Forgiveness (PSLF) Eligible Employer
About Gainesville, Florida
Home to the University of Florida, one of the nation's top public universities, Gainesville offers vibrant academic and healthcare communities alongside an affordable cost of living, no state income tax, and mild winters. Enjoy the outdoors with over 30 miles of bike trails, freshwater springs, and numerous water activities, plus easy access to beaches and world-class theme parks.
Gainesville combines historic charm with modern amenities, including a great school system, a lively downtown, and a thriving local culture with farmers' markets and craft breweries. Discover professional growth and quality of life in Gainesville—where community, innovation, and work-life balance meet!
For more information, check out: The Guide to Greater Gainesville and Explore Gainesville in 60 seconds
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