Job Description

Job Description:

The Clinical Research Nurse plays an integral role for leading the coordination and management of the assigned protocols. Job duties will include screening potential patients for eligibility, providing study specific education to patients, families, and colleagues, conducting informed consent discussions and visits, and acting as a liaison with internal and external stakeholders involved in the clinical trial activities. Demonstrating knowledge and understanding of human research policies, regulations, procedures, and standards according to FDA, ICH/GCP guidelines is required. This position interacts with a variety of people, both internal and external, requiring exceptional communication skills. The ability to multi-task and remain organized in a high-volume clinical trial setting is required.

Principal Duties and Responsibilities:

• Participate in study development including protocol review, informed consent review and create study tools for the conduct of a clinical trial.

• Provide nursing expertise to the research team during study development and implementation.

• Facilitate education of the interdisciplinary team on study requirements.

• Identify and assist with procuring equipment and supplies for the trial requirements.

• Facilitate the initial and ongoing informed consent/assent process with research participants.

• Ensure the trial is conducted according to the protocol, ICH/GCP and FDA guidelines.

• Administer study treatment interventions.

• Collect specimens (blood, urine, CSF, tumor samples) for clinical and research testing.

• Facilitate the processing and shipment of research specimens as defined in the study protocol or lab manual(s).

• Obtain medical histories and conduct safety assessments such as vital signs, EKGs and report potential adverse events.

• Record research data in approved source documents and into study-specific databases. Review and respond to data queries in a timely manner.

• Prepare for and participate in site monitoring visits and/or audits.

• Assist with process improvement projects.

• Assist in the development of Standard Operating Procedures and Work Instructions.

• Performs miscellaneous job-related duties as assigned.

Required Qualifications:

• Bachelor’s degree or equivalent combination of education and experience.

• 3+ years of RN experience

• AZ RN license or eligible.

• Experience working in OR, Neurology and/or Oncology setting

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