Clinical Research Coordinator III - Neurology - Multiple Sclerosis Division

University of Florida•Gainesville, FL

5d•$59,700 - $70,000

About The Position

The Department of Neurology, Division of General Neurology, Multiple Sclerosis (MS) subdivision is seeking a Clinical Research Coordinator III with at least three years of human subject research experience. The position is responsible for the daily operations of clinical trial studies run by the MS Section, including regulatory documentation and submissions for research and clinical trial activity through the University of Florida Health Professions IRB and a central IRB. The coordinator manages the care and protocol-required testing of subjects enrolled in assigned trials; collects and interprets clinical data; supports study compliance, audits, and regulatory reporting; coordinates study-related fiscal tracking and laboratory samples; and mentors and supports research staff. The role also contributes to internal policies, procedures, quality control, and research operations. Other duties may be assigned as needed to fulfill the mission and values of the UF Department of Neurology.

Requirements

Bachelor's degree in an appropriate area and three years of relevant experience, or an equivalent combination of education and experience.
Valid driver’s license and dependable transportation.
Submit a cover letter, resume, and contact information for three professional references with the application.

Nice To Haves

Three or more years of human subject research experience.
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.
Ability to interpret complex guidelines.
Effective communication skills and ability to meet deadlines.
Ability to work effectively both independently and as a team player, interact professionally, and use effective writing and organizational skills.
Understanding and effective use of emotional-intelligence strategies and skills.
Ability to handle confidential information discreetly, adapt to competing demands, and provide a high level of customer or client service and responsiveness.
Ability to achieve performance goals and meet deadlines in a fast-paced environment.
Forward-thinking approach, initiative in identifying opportunities, creative problem-solving, and strong decision-making capability.

Responsibilities

Coordinate care and protocol-required testing for subjects enrolled in assigned trials.
Educate subjects about informed consent and protocol-related medical topics, procedures, schedules, and potential side effects; ensure consent documents are properly executed and register or randomize subjects with sponsors as appropriate.
Follow subjects’ hospitalizations, clinic visits, treatments, and scheduled activities, ensuring protocol-specific tests and procedures are completed within study timelines.
Order protocol tests and communicate results to investigators, providers, subjects, and families as applicable.
Communicate regularly with subjects, assess progress and problems, and consult investigators or physicians when needed.
Coordinate with family members, investigators, physicians, providers, nurses, and other health care agencies regarding patient care and follow-up.
Prepare study orders and information sheets and obtain required approvals; coordinate with investigational pharmacy staff to ensure study drug availability before appointments.
Attend research and investigator meetings, prepare or present requested information, and represent the University of Florida professionally.
Track subject status changes in the Clinical Trials Management System (CTMS).
Collect and interpret medical-record and clinical data, including histories, diagnoses, pathology, laboratory and radiology results, specialty tests, progress notes, adverse reactions, and dose modifications; enter data into sponsor-specific case report forms and delegate as appropriate.
Identify potential study candidates and confirm eligibility with investigators through clinics, conferences, interviews, and medical-record review.
Provide accurate and complete study data to sponsors within protocol timelines and protect subject privacy through compliant research records and case report forms.
Evaluate and grade clinical toxicities using protocol criteria, and provide guidance to Study Coordinator I and II staff.
Maintain compliance with internal, external, regulatory, and institutional requirements; attend required trainings and provide protocol-related in-service education.
Collaborate with monitors and sponsor data-management units to resolve case-report-form discrepancies, answer queries, monitor data delinquencies, and respond to special requests.
Participate in internal and external inspections and audits; direct concerns about protocol violations to the principal investigator or appropriate provider.
Coordinate regulatory submissions with internal and external IRBs, including continuing reviews, study closures, adverse event reports, protocol revisions, and other documents within required timelines.
Report serious adverse events and planned or unplanned subject deviations to the IRB, sponsor, and/or FDA as required; prepare cumulative adverse-event tables and deviation reports.
Act as liaison between the institution and clinical trial sponsors and data managers.
Participate in fiscal audits, submit research study orders for sponsor- or study-paid services, maintain copies of orders, and record service dates for protocol-related visits.
Coordinate collection, processing, labeling, storage, and shipment of research and clinical samples according to protocol, sponsor requirements, and applicable safety and regulatory requirements.
Mentor new Clinical Research Assistants (CRAs) and Study Coordinators (SCs), including onboarding, retraining, and in-service training related to neurology, clinical research, and patient care.
Support clinical staff in implementing research protocols and reviewing subject cases.
Serve on internal committees and working groups developing SOPs, workflows, metrics, policies, and procedures; coordinate internal quality-control activities.
Perform other duties as needed to fulfill the mission and values of the UF Department of Neurology.