Clinical Research Coordinator III - Neurology - Multiple Sclerosis Division

University of Florida•Gainesville, FL

About The Position

The Department of Neurology, Division of General Neurology, Multiple Sclerosis subdivision, is seeking a Clinical Research Coordinator III with at least three years of human subject research experience. The coordinator manages the daily operations of clinical trial studies conducted by the MS Section and ensures regulatory documentation is completed and submitted as appropriate, including new submissions, continuing reviews, and revisions through the University of Florida Health Professions IRB and a central IRB. The position coordinates care and protocol-required testing for participants enrolled in assigned trials; interprets and collects clinical data; supports study compliance, monitoring, and audits; and coordinates research samples. The coordinator also provides mentorship and protocol guidance to research staff, contributes to quality-control efforts, and supports the development and implementation of procedures. This is a time-limited position. A valid driver’s license and dependable transportation are required.

Requirements

Bachelor's degree in an appropriate area and three years of relevant experience, or an equivalent combination of education and experience.
At least three years of human subject research experience.
Valid driver’s license and dependable transportation.
Ability to interpret complex guidelines, communicate effectively, and meet deadlines.
Ability to work independently and effectively as a team member, interact professionally, and use effective writing and organizational skills.
Ability to handle confidential information with discretion and adapt to competing demands.
Ability to achieve performance goals and meet deadlines in a fast-paced environment.
Application must include a cover letter, resume, and contact information for three professional references.

Nice To Haves

Knowledge of NIH and FDA procedures.
Knowledge of state and federal regulations regarding clinical research.
Knowledge of accepted procedures and ethical, confidential practices.
Proficiency with personal computer software, including Microsoft Office.
Demonstrated understanding and effective use of emotional-intelligence strategies and skills.
Demonstrated customer/client service and responsiveness.
Forward-thinking approach, creative problem-solving, and strong decision-making capability.

Responsibilities

Coordinate care and protocol-required testing for participants enrolled in assigned trials, including consent education, registration or randomization, visit coordination, and follow-up.
Communicate with participants, families, investigators, physicians, providers, nurses, and other agencies involved in participant care and follow-up.
Order protocol tests, communicate results to relevant parties, prepare study orders and information sheets, and coordinate with investigational pharmacy staff to ensure study medication availability.
Track participant status in the Clinical Trials Management System and confirm protocol-specific tests and procedures are completed within study timelines.
Collect and interpret medical-record and clinical data, assess potential participants, and confirm eligibility with investigators.
Enter clinical data into sponsor-specific case report forms and provide complete, accurate data to sponsors within protocol timelines.
Maintain participant privacy and research documentation in compliance with privacy laws; evaluate and grade clinical toxicities according to protocol criteria.
Provide onboarding, protocol assistance, and guidance to Study Coordinators and Clinical Research Assistants.
Ensure compliance with internal, external, regulatory, and institutional requirements; attend required training and provide protocol-related in-service education.
Collaborate with monitors and sponsor data-management units, resolve case-report-form discrepancies, respond to data queries, and participate in inspections and audits.
Collaborate with IRB staff and specialists to submit regulatory documents, continuing reviews, study closures, adverse-event reports, protocol revisions, and other required materials on time.
Report serious adverse events and planned or unplanned subject deviations to the IRB, sponsor, and/or FDA according to reporting requirements; prepare cumulative adverse-event tables and deviation reports as needed.
Participate in fiscal audits, submit research study orders for sponsor- or study-paid services, and record protocol-related study visit service dates.
Coordinate research sample collection, labeling, processing, storage, and shipment in accordance with protocol, sponsor, and applicable safety and regulatory requirements.
Mentor new Clinical Research Assistants and Study Coordinators, and serve as a resource to clinical staff implementing protocols and reviewing participant cases.
Serve on internal committees and working groups to develop SOPs, workflows, and metrics, and coordinate internal quality-control activities.
Perform other duties as needed to fulfill the mission and values of the UF Department of Neurology.