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

Work type: Staff Full-Time

Categories: Allied Health, Health Care Administration/Support

Department: 29190000 - MD-NEUROLOGICAL SURGERY

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:

The Clinical Research Nurse described herein works in the Department of Neurosurgery, College of Medicine, University of Florida. This position is responsible for the coordination, management, and regulatory functions of assigned clinical research trials and projects within The University of Florida Brain Tumor Immunotherapy Program (UFBTIP).

More About This Role

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, monitoring visits, and close-out 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 trial-specific 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 site-specific 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 follow-up and resolution of issues

• Assist with creation of study-specific databases and documents for clinical trial execution.

• Develop site-training materials.

Expected Salary:

$81,000-$92,200

Required Qualifications: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.

Preferred:

EXPERIENCE

• Neuro-oncology, medical oncology, or neurosurgical experience

• Clinical research experience

• Patient management experience

Special Instructions to Applicants:

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 an Equal Employment Opportunity Employer.

Application must be submitted by 11:55 p.m. (ET) of the posting end date.

Health Assessment Required:Yes

Advertised: 19 May 2025 Eastern Daylight Time

Applications close: 25 May 2025 Eastern Daylight Time