Clinical Research Coordinator III – Neurology – Neuromuscular Division

Classification

Title:

Clinical Research Coordinator III Job Description

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.

• 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,…