Clinical Research Coord II - Neuro - Neuromuscular Neurology

Clinical Research Coord II

The University of Floridas 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

• 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 subjects 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 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 in the administration and toxicity assessment of protocol
  regimens
• 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

We Offer Exceptional Benefits:

• Low-cost State Health Plans: Medical Dental and Vision Insurance
• Life and Disability Insurance
• Generous Retirement Options to secure your future
• Comprehensive Paid Time Off Packages:(includes over 10 paid holidays as well as paid family sick and vacation leave)
• Exceptional Personal and Professional Development Opportunities: Access to UF Training & Organizational Development programs leadership development LinkedIn Learning and more
• Tuition Assistancethrough theUF Employee Education Program
• Public Service Loan Forgiveness (PSLF) Eligible Employer

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