Job Description

Clinical Research Nurse Practitioner

Location: Phoenix, AZ

Type : Full time

General Description of the position:

Clinical trials are governed by Good Clinical Practice (GCP) guidelines. The conduct of clinical

trials follows a trial-specific detailed protocol that governs the activities of the research staff

involved in the trial. The Clinical Research Nurse Practitioner (CRNP) will conduct or assist in the

conduct of clinical trials adhering to the best medical and scientific standards (according to GCP, SOPs, local regulations and the Declaration of Helsinki). This is a direct patient care position in clinical research trials.

The CRNP may be delegated by the Principal Investigator (PI) to be a sub-Investigator on clinical

trials.

Main Responsibilities:

• Conduct Study Activities as delegated by the Principal Investigator and the Study Project Manager and in compliance with study protocol, GCPs, applicable FDA regulations, including but not limited to:
• Perform vital signs, physical examinations, and other clinical procedures in accordance with trial protocol
• Perform phlebotomy
• Order diagnostic tests / procedures as required, and liaise with clinical collaborating departments and specialists according to the trial protocol schedule of activity
• Oversee study drug/treatment ( study drug dispensation, preparation, administration)
• Maintain study drug logs, worksheets, labels
• Monitor and record patient response to treatment, adverse events (AEs) and serious adverse events (SAEs)
• Coordinate medical questions and procedures with PI and study sub-Investigators
• Coordinate patient treatment / AE management plan with investigators and Medical Director
• Ensure accurate and detailed on-time documentation
• Prescribe medication and other treatments as necessary
• Discuss and obtain informed consent from trial participants in accordance with ICH GCP and SOPs
• Ensure accurate and detailed on-time documentation, complete CRFs (electronic/paper), maintain source documentation
• Handle medical emergencies in accordance with study protocol, SOPs and applicable regulations.
• Assist with study feasibility review, provide medical and scientific feedback on trial protocols, publications and study records.
• Work with study coordinators to ensure trials are set up properly, and that there is an adequate inventory of investigational product, ancillary medications, and study supplies.
• Assist with patient recruitment, screening, and retention.
• Participate in review and development of standard internal documentation (SOPs, working instructions, forms and templates, etc.).
• Participate in relevant monitoring visits, audits, and inspections by sponsors and other related agencies for the purpose of monitoring the accuracy and quality of the collected data
• Other duties as assigned.

Minimum Qualifications

• Degree: Master’s degree in Nursing (MSN) from an accredited institution with advanced clinical training.
• Minimum one year of experience as a nurse practitioner.
• Hold an active and unencumbered license to practice as a registered nurse in Arizona.
• National NP Certified.

Knowledge, Skills and Abilities - Required

• Ability to recruit, evaluate and instruct clinical research subjects.
• Ability to plan and execute proactively.
• Ability to draw blood, administer IVs and perform standard nursing procedures.
• Knowledge of clinical evaluation and triage procedures.
• Ability to observe, assess and record patient symptoms, reactions and progress.
• Ability to develop and manage nursing care plans.
• Ability to maintain quality, safety and /or infection control standards.
• Ability to provide direct nursing care and consultation to patients.
• Well-organized, detail-oriented, meticulous, and have the ability to establish and maintain an excellent rapport with patients.
• Professional demeanor and strong interpersonal and communication skills.
• Ability to work effectively with team members and with a wide range of constituencies in a diverse community.
• Ability to work flexible hours as required by the trial protocol.
• Possess empathy and sensitivity skills.
• Ability to remain calm in highly stressful situations.
• Team spirit, reliability, discipline, accuracy, quick reaction time with solution-oriented thinking.
• Excellent oral and written communication skills.
• Basic knowledge of MS Office.

Knowledge, Skills and Abilities - Preferred

• Prior working experience with the principles and procedures of clinical research.
• Knowledge of instruments and equipment commonly used in clinical research.
• Knowledge of ethical principles and federal and state regulations governing the participation of human subjects in clinical research.
• Knowledge of GCP, federal, state, and local regulations, including HIPAA policies and procedures.
• CPR/ACLS certified, GCP, and IATA trained. Note: Our client will support trainings, initial certifications and recertifications as necessary.
• Knowledge of the Spanish language.

Reporting and Collaboration Lines

• Direct Report to: Medical Director.
• Indirect Report to: Regional Executive Director.
• Functional Collaboration with: Project Managers, Study Nurses, PIs, Sub-Investigators, collaborating physicians.
• Cross-Functional Collaboration with: Quality Assurance and other clinic and corporate personnel.

Working conditions and physical effort

• Work is performed in a medical/clinical environment.
• Work environment involves exposure to potentially dangerous materials and situations that require following precautions and may include the use of protective equipment, for example, airborne communicable diseases, fumes or airborne particles.
• Work with blood or blood-borne pathogens; Our client will provide all training required by OSHA to ensure employee safety.
• Moderate physical activity. Requires handling of average-weight objects up to 35 pounds, standing and/or walking for more than 4 hours per day.

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