Clinical Research Coord III

The Department of Neurology, Neuromuscular Division at the University of Florida is seeking an experienced Clinical Research Coordinator III to lead the coordination and regulatory management of complex, multi-phase clinical trials under the direction of Dr. James Wymer and the Assistant Director of Clinical Trials. This role involves direct oversight of subject care within assigned protocols, including patient education, data collection, regulatory compliance, and collaboration with investigators and sponsors. The coordinator will also support audits, manage IRB submissions, and serve as a key resource for junior research staff. Ideal candidates will have a strong background in clinical research, excellent organizational skills, and a commitment to advancing neuromuscular research through high-quality trial execution.

About this Role

The successful candidate will:

• Coordinate the care and protocol-required testing for research participants enrolled in multiple, complex clinical trials under the Neuromuscular Division. Responsibilities include scheduling and tracking subject visits, ensuring protocol adherence, and maintaining regular communication with participants, providers, and investigators throughout the study.
• Educate subjects and their families on the informed consent process, study procedures, testing schedules, potential side effects of investigational drugs, and other protocol-related topics. Ensure proper execution of informed consent and register/randomize subjects with study sponsors.
• Order protocol-required tests and labs; communicate results to physicians, investigators, and participants as appropriate. Monitor inpatient and outpatient subject visits to ensure timely completion of all study-specific procedures and interventions.
• Prepare and maintain accurate and up-to-date pre-printed/electronic study orders and study information sheets; collaborate with investigational pharmacy staff to ensure investigational products are available and prepared for study visits.
• Enter and maintain subject information, visit outcomes, and status changes in the Clinical Trials Management System (CTMS); attend investigator meetings and represent the department in a professional manner.
• Collect and interpret clinical data including patient history, diagnosis, laboratory/radiology reports, adverse events, and treatment outcomes from medical records and subject interviews. Accurately transcribe and submit data to sponsors via case report forms, delegating to CRAs when appropriate.
• Identify and assess eligibility of potential protocol candidates through patient interviews, chart reviews, and participation in care conferences; ensure timely and complete data submission to sponsors and maintain confidentiality in compliance with HIPAA and other regulations.
• Evaluate clinical toxicities and adverse reactions using protocol-specific grading criteria in collaboration with the principal investigator. Provide support to Study Coordinators I and II in clinical data interpretation and documentation.
• Ensure full compliance with internal and external regulatory and institutional requirements by preparing and submitting IRB documents (initial submissions, amendments, continuing reviews, closure reports), and promptly reporting serious adverse events and deviations to appropriate regulatory bodies.
• Participate in sponsor and institutional audits by resolving data queries, responding to data discrepancies, and collaborating with monitors and QA personnel to maintain compliance.
• Perform research billing review for protocol-related services, submit study-related orders for sponsor-paid services, maintain CTMS revenue tracking logs, and document protocol visit service dates in appropriate databases.
• Coordinate collection, processing, labeling, storage, and shipping of biological specimens in accordance with study protocols, safety procedures, and shipping regulations. Ensure proper sample handling and documentation throughout the chain of custody.
• Mentor and train new Clinical Research Assistants (CRAs) and Study Coordinators (SCs); provide in-service education on neurology protocols, patient care, and research best practices. Participate in onboarding, retraining, and competency development as assigned.
• Serve on internal committees and working groups to develop SOPs, workflows, and quality metrics. Collaborate with leadership to implement policy changes and improve internal processes related to clinical research operations.
• Support internal quality control activities and help coordinate continuous improvement initiatives alongside monitors and study staff.

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

$61,000 to $70,000; Commensurate with education and experience. 

The ideal candidate must possess:

• Proficiency in Microsoft Office Suite, with a strong emphasis on Outlook, Excel, and Word.
• Excellent interpersonal skills and the ability to collaborate with a wide range of individuals, including investigators, physicians, clinical and hospital staff, sponsors, and external partners.
• Highly resourceful and collaborative team player with the ability to work independently, demonstrating strong writing, communication, and organizational skills.
• Demonstrated understanding and application of Emotional Intelligence strategies in professional settings.
• Proven ability to manage confidential information with discretion and professionalism, while maintaining adaptability in response to competing priorities.
• Strong customer service orientation with a demonstrated ability to meet performance goals and deadlines in a fast-paced environment.
• Forward-thinking mindset with a proactive approach to problem-solving and decision-making.
• Ability to build and maintain effective working relationships with stakeholders across multiple levels and organizations using various communication methods.
• Possesses a project management mindset with basic skills in delegation, scheduling, communication, critical thinking, task and quality management, and risk management.
• Professional clinical research certification (SOCRA or ACRP) is preferred at the time of hire.

To be considered, please upload the following documents with your application:

• Cover Letter
• Resume
• Contact information for three professional references

This is a time limited position.

Application must be submitted by 11:55 p.m. (ET) of the posting end date.