Clinical Research Coord II-Multiple Sclerosis (MS) Division

Classification Title:

Clinical Research Coord II

Classification Minimum Requirements:

Bachelor’s degree in an appropriate area and two years of relevant experience; or an equivalent combination of education and experience.

Job Description:

The Multiple Sclerosis (MS) and Neuroimmunology Section in the Department of Neurology is seeking passionate clinical research coordinators who want to further the mission of research and pursue the prevention and treatment of MS and other immune-mediated disorders of the central nervous system (CNS). If you have 2 years or more of human subject research experience and you are detailed-oriented, motivated, passionate about clinical research, and enjoy working collaboratively to meet shared goals and objectives, we hope you apply! We are currently involved in multiple multicentered drug trials for Multiple Sclerosis. The Clinical Research Coordinator II is responsible for the daily operations of clinical trial studies run by the MS Section. Responsible for ensuring that all required regulatory documentation is completed and submitted as appropriate for all research/clinical trial activity which includes, but is not limited to, new submissions, continuing reviews, and revisions through the University of Florida Health Professions IRB and a central IRB.

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 communicate 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 investigation agent is available prior to subject appointments.
• Attends 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) OnCore.

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. Transcribe 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 s