Clinical Research Coord II - Neuro - Neuromuscular Neurology

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Job No: 536930

Work Type: Full Time

Location: Main Campus (Gainesville, FL)

Categories: Grant or Research Administration

Department:  - MD-NEUROMUSCULAR NEUROLOGY



Job Description

Classification

Title:

Clinical Research Coord II



Job Description :

The University of Florida's Department of Neurology, Division of Neuromuscular, is seeking an eager and qualified Clinical Research Coordinator II to support our mission of advancing research in the prevention and treatment of neuromuscular disorders. We are looking for a candidate with at least two years of human subject research experience, who is detail-oriented, motivated, and excels in collaborative environments to help achieve shared research goals.

The selected candidate will be responsible for managing the daily operations of clinical trial studies conducted within the Neuromuscular Division. This includes ensuring that all required regulatory documentation is accurately prepared and submitted in a timely manner for all research and clinical trial activities. Responsibilities encompass submissions such as initial applications, continuing reviews, and protocol revisions through both the University of Florida Health Professions IRB and central IRBs.

About This Role:

Coordination of Protocol Subjects

Incumbent Is Responsible For The Coordination Of Relevant Care And Protocol Required Testing For Subjects Enrolled On Their Assigned Trials. This Includes The Following Tasks:

• Educates subjects on topics related to the informed consent document and confirms that informed consent documents are appropriately executed, registers and/or randomizes patients with appropriate sponsor
• Educates subjects and families on the medical aspects of protocols, testing procedures, visit schedules, and side effects of chemotherapy and/or other therapeutic drugs
• Follows subject hospitalizations, clinic/office visits, treatments and scheduled activities
• Orders protocol tests and communicates these test results to investigators, treating providers, subjects, and their families, as applicable
• Communicates with subjects on a regularly scheduled basis and assesses progress, evaluates problems and determines appropriate action or investigator/physician consultation as needed
• Communicates and interacts with family members, investigators, physicians, providers, nurses and other health care agencies involved with the patients care and follow-up status
• Prepares pre-printed and electronic study orders and study information sheets and secures appropriate approvals as required
• Communicates with investigational pharmacy staff regarding subject enrollment, ensuring an adequate supply of investigational agent is available prior to subject appointments
• Attend weekly Division research meetings, investigator meetings, and represents the University of Florida in a professional manner
• Follows each subject's clinical course during inpatient hospitalizations and at clinic visits, confirming that all protocol-specific tests and procedures are completed within study timelines
• Enters and tracks all subject status changes in the Clinical Trials Management System (CTMS)

• Collects and interprets data from medical records, including medical history, diagnosis, pathology, laboratory, radiology, specialty test results, progress notes, reported side effects or adverse reactions and dose modifications. Transcribes clinical data into sponsor-specific case report forms, delegating to Clinical Research Assistants (CRA) as appropriate
• Identifies possible protocol candidates and confirms patient eligibility with the investigator for protocol participation by attending patient care conferences/clinics, interviewing prospective participants, and reviewing…