Clinical Research Coord II - Neuro - Neuromuscular Neurology

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)

Chart Review & Data Interpretation

Incumbent is responsible for the interpretation and collection of medical and clinical data of potential and existing subjects on assigned clinical trials. This includes the following tasks:

• 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 medical records
• Provides accurate and complete data to study sponsors according to protocol timelines
• Protects subject privacy by maintaining complete case report forms and/or research charts in compliance
  with privacy laws
• Evaluates, interprets and grades clinical toxicities noted in the medical record and subject diaries using the grading criteria specified in the protocol
• Provides guidance and assistance to Study Coordinator Is in the assessment of clinical data

Compliance

Incumbent is responsible for all compliance with all internal and external regulatory and institutional requirements related to the trials assigned to them. Overall compliance responsibilities can be broken out into the following sections and tasks:

Monitor Audits and QA:

• Collaborates with monitors and/or with sponsors’ data management units to re