Clinical Research Nurse-Department of Neurosurgery--Neuro-oncology Research
Clinical Research Nurse-Department of Neurosurgery--Neuro-oncology Research
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$ 81000 - 92200
1 Vacancy
Job Description
Clinical Research Nurse
Coordinate assigned neurooncology 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 clinicalresearch 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 clinicalresearch 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 clinicalresearch 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 clinicalresearch 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 onsite 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 clinicalresearch nurse coordinator(s) with IRB billing and administrative activities
Develop execute
Project Management of Complex Multisite Clinical Trial Activities:
Perform site initiation visits monitoring visits and closeout visits in accordance with the protocol
monitoring plan applicable SOPs ICH guidelines and all applicable regulatory requirements.
Assess site protocol and regulatory compliance including but not limited to source document
verification informed consent process and human subject protection data integrity device/drug
accountability and compliance and review of investigator and regulatory files
Foster strong collaborative relationship with investigators and staff at assigned study sites
Serve as the point person for trialspecific activities working with study team members as directed by
the Principal Investigator
Assess adequacy of site personnel and facilities for study conduct. Provide study training and guidance
to designated site personnel for conducting studies in accordance with the protocol SOPs trial specific
procedures and applicable regulations.
Proactively recognize document and assist in the resolution of study sitespecific issues including but
not limited to subject recruitment data quality and study conduct.
Generate and assist in the closure of data queries as appropriate. Communicate routine and unusual
findings to trial supervisor. Document ongoing followup and resolution of issues
Assist with creation of studyspecific databases and documents for clinical trial execution.
Develop sitetraining materials.
$81000$92200
EXPERIENCE
Neurooncology medical oncology or neurosurgical experience
Clinical research experience
Patient management experience
For consideration please complete an application and include a cover letter resume and the names and email addresses of three to five references.
The University of Florida is committed to nondiscrimination with respect to race creed color religion age disability sex sexual orientation gender identity and expression marital status national origin political opinions or affiliations genetic information and veteran status in all aspects of employment including recruitment hiring promotions transfers discipline terminations wage and salary administration benefits and training.
Application must be submitted by 11:55 p.m. (ET) of the posting end date.
Employment Type
Full-Time
