| Job Description: |
The Department of Neurology, Division of General Neurology, subdivision of Multiple Sclerosis (MS) is seeking candidates with at least three years of human subject research experience for a Clinical Research Coordinator III position. The Clinical Research Coordinator III is responsible for the daily operations of clinical trial studies run by the MS Section. Responsible for ensuring 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.
More About this Position
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 subjects 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
- Order 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
- Attends research meetings, preparing and/or presenting requested information
- 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)
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 subject 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 and IIs during onboarding and provide protocol assistance
Compliance: Incumbent is responsible for all compliance with all internal and external regulatory and institutional requirements related to the trials assigned to them. Responsible for attending all relevant trainings monthly as required and provides in-service education related to assigned protocols to ensure compliance. 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 resolve case report form discrepancies
- Answers data queries, monitors for data delinquencies, and replies to special requests as necessary
- Participates in internal and external inspections and audits of subject medical records to ensure compliance with the protocol
- Acts as resource for Study Coordinator Is and IIs in the administration of protocol assessments
- Directs concerns of protocol violations to PI and/or appropriate treating provider. IRB and Regulatory
- Collaborates with internal and external IRB staff to ensure all regulatory documents are appropriately submitted
- Communicates serious adverse events and both planned and unplanned subject deviations to the IRB, sponsor, and/or FDA according to established reporting requirements
- Acts as liaison for institution with clinical trial sponsors and data managers involved with protocols
- Works with internal IRB Specialists to submit continuing review/study closure reports, serious adverse event reports, protocol revisions and other documents to the IRB within appropriate timelines to prevent project expiration or sponsor deficiencies
- Prepares cumulative adverse event tables and deviation reports as required for continuing review or closure reports
Fiscal:
- Participates in fiscal audits to ensure compliance with established billing procedures
- Facilitates the submission of research study orders for all sponsor/study-paid services and maintains department copies of all submitted orders
- Records the service dates for all protocol-related study visits using the appropriate tracking log or database system
Laboratory: Incumbent is responsible for the coordination of all sample collection, analysis, and shipping for assigned trials, includes the following tasks (may be delegated to CRAs as appropriate):
- Coordinates research sample collection with clinical and/or research collection personnel and confirms samples are appropriately labeled following collection
- Adheres to pertinent safety and quality policies and procedures for the handling, processing, disposal, and shipping of biological specimens
- Ensures that research samples are processed according to protocol or sponsor requirements
- Verifies that research samples are stored appropriately until shipment
- Prepares samples for shipment as required by the protocol and ship samples in accordance with protocol, local, state and federal requirements
- Obtains, processes, stores and ships clinical samples according to sponsor requirements
Strategy:
- Provides mentorship to new CRAs and SCs, including in-service training related to neurology, clinical research, and patient care topics. May be assigned to one-on-one mentorship and training tasks for onboarding and retraining purposes
- Acts as resource for clinical staff with the implementation of clinical research protocols and review of subject cases
- Serves on internal committees for the creation of SOPs, workflows, and metrics. Collaborates with leadership and support staff to implement and change policies and/or procedures
- Participates in working groups and coordinates internal quality control activities in conjunction with internal Monitors and other related staff
Any other duties, as needed, to fulfill the mission and to abide by the values of the UF Department of Neurology
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