Clinical Research Nurse-Department of Neurosurgery--Neuro-oncology Research

Classification Title:

Clinical Research Nurse

Classification Minimum Requirements: Graduate of a nationally accredited nursing program and four years of professional nursing experience. Licensed as a registered nurse in accordance with Chapter 464, Florida Statutes. Job Description:

Coordinate assigned neuro-oncology clinical research trials and projects in the clinic and
surgical settings:
• Serve as a contact and liaison between medical staff, nursing staff, and other university and hospital
departments as well as the sponsor (when applicable)
• Maintain SOPs (standard operating procedures) and other clinical research related documents for the
research team
• Train and continually educate clinical research team, medical staff, nursing staff, and affiliates on
protocols and protocol compliance
• Train and continually educate clinical research team, medical staff, nursing staff, and affiliates on
trial eligibility requirements and actively encourage them to maximize clinical trial enrollment
• Retain and distribute sponsor literature to assist staff in maintaining patient eligibility for clinical trials and
projects, as well as how to contact study investigators and research team
• Coordinate with investigational pharmacy for storage, randomization, and distribution of medications for
assigned protocols
• Coordinate with those responsible in the clinic and surgical settings for the space, equipment, supplies,
resources, and expertise needed to conduct the clinical research trials and projects successfully
• Prepare IRB reports and paperwork and report deadlines to PI and his/her staff
• Assist in the development of quality assurance checks within the facility for the assigned clinical trials
• Administer, conduct, collect, and record, patient and family related questionnaires, tests, surveys, and
other clinical research related materials and correspondence
• Follow the protocols as written

Provide education and nursing care in support of clinical-research trials and projects in clinic and
surgical settings:
• Serve as a contact and liaison between the clinical research team, neurosurgery research office,
patients, families, outside agencies, and the public
• Initially train and continually educate and support prospective or existing patients, families, and the
public about clinical research trials, projects, and events
• Actively screen prospective and current patients for eligibility into clinical research trials
• Obtain informed consent from the subject or appropriate family member, after ensuring that subject
meets eligibility criteria
• Initiate ordering of necessary tests, equipment, and medications per protocol
• Collect body fluid specimens for processing and shipping, as necessary
• Provide patient education and medical nursing care to patient and/or families on medical or surgical
aspects of the clinical-research trials and projects
• Under the supervision of the attending direct patient to appropriate medical care, if needed, and notify
both the appropriate medical personnel and investigator(s) of these directives

• Review lab and test results and inform the appropriate individuals, including the investigator(s) of
abnormal results

Provide administrative and regulatory support for assigned clinical-research trials and projects
• Maintain detailed records of clinical research trials and projects, including data collection, while
maintaining HIPAA compliance standards regarding patient confidentiality
• Obtain appropriate data and record and maintain them in database and/or other recording systems
• Maintain case reports forms (CRFs) and other source documents
• Alert Principal Investigator(s) to any AE/SAEs (Adverse Event/Serious Adverse Event), for timely
reporting to the IRB (and sponsors), if appropriate
• Assist in regulatory management of FDA (Federal Drug Administration) required documentation on
Investigational New Drug (IND) governed studies
• Provide weekly screening and patient progress reports to clinical-research nurse coordinator(s) or other
designated individual(s)
• Assist and compile progress reports for funding sources, regulatory sources, investigator(s) and
department research office
• Assist with on-site visits and data monitoring for protocol adherence
• Complete Institutional Review Board reports and paperwork, as needed, maintaining compliance with all
regulatory requirements and guidelines
• Assist the clinical-research nurse coordinator(s) with IRB, billing, and administrative activities
• Develop, execute,

Project Management of Complex Multi-site Clinical Trial Activities:
• Perform site initiation visits, monitori