Job Description

Clinical Research Nurse

Location: Phoenix, AZ

Type : Full time

General Description of the position:

Clinical trials are governed by Good Clinical Practice (GCP) guidelines. These guidelines provide instruction to Clinical Research Nurses in areas where specialist subject knowledge is necessary.

The conduct of clinical trials follows a trial-specific detailed protocol that governs the activities of the whole research staff involved in the trial. The Clinical Research Nurse is responsible for the proper execution of the trial protocol according to assigned responsibilities, 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.

Main Responsibilities:

• Conduct Study Activities as delegated by Principal Investigator and in compliance with study protocol, GCP, applicable FDA regulations, including but not limited to:
• Administer prescribed study/concomitant medications
• Perform phlebotomy
• Handle collection, processing and shipment of biological samples
• Perform ECGs, monitor vital signs, and/or other specialized nursing procedures
• Ensure the accurate implementation of time/event schedules during the trial; schedule patient visits according to trial protocol, arrange follow-up with patients as required
• Maintain laboratory kits inventory
• Use medical equipment according to the manuals and take care of their maintenance.
• Maintain and ensure accuracy of temperature logs of temperature-controlled equipment
• Administer questionnaires and ensure patients are compliant with diet requirements stated in diet plan / trial protocol
• Monitor and record patient response to treatment, adverse events (AEs) and serious adverse events (SAEs). Coordinate medical care with investigators, sub-investigators and Medical Director
• Ensure accurate and detailed on-time documentation
• Advise on operational feasibility of the trial (e.g., assessment of required resources, review of study manuals and assessment of specific procedures, assistance with study feasibility questionnaire completion, etc.)
• Handle foreseeable medical emergencies, maintain emergency kit
• Work with study coordinators to assist in study set-up and initiation, ensure adequate inventory of investigational product, ancillary medications, trial, nursing and lab supplies.
• Participate in review and development of internal standard documentation for research processes (SOPs, forms, instructions, templates, etc.)
• Attend trial team and relevant sponsor meetings and provide regular updates on study progress
• Perform other job duties as assigned

Minimum Qualifications

• Degree: Bachelor’s in nursing from an accredited institution
• Certification/Licensure: State of Arizona Licensed Registered Nurse or licensure pending as documented by temporary licensure

Knowledge, Skills and Abilities - Required

• Ability to provide direct nursing care and consultation to patients
• Detail-oriented and ability to establish and maintain an excellent rapport with patients
• Ability to draw blood, administer IVs and perform standard nursing procedures
• Knowledge of patient evaluation and triage procedures
• Ability to observe, assess and record patient symptoms, reactions and progress
• Ability to maintain quality, safety and /or infection control standards
• Strong interpersonal and communication skills and the 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.
• Well-organized and capable of planning activities in advance during their shift
• Team spirit, reliability, discipline, accuracy, quick reaction time with solution-oriented thinking
• Basic knowledge of MS Office

Knowledge, Skills and Abilities - Preferred

• Prior working experience with the principles and procedures of clinical research
• Knowledge of facilities, 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 FDA regulations
• CPR/ACLS certified, GCP, phlebotomy and IATA trained
• Note: Client will support trainings, initial certifications and recertifications as necessary
• Knowledge of the Spanish language

Reporting and Collaboration Lines

• Direct Report to: Regional Medical Director.
• Indirect Report to: Regional Executive Director.
• Functional Collaboration with: Project Managers, Clinical Research Nurse Practitioners, PIs, Sub-Is, 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
• Work with blood or blood-borne pathogens
• Moderate physical activity. Requires handling of average-weight objects up to 35 pounds, standing and/or walking for more than 4 hours per day
• Client will provide all training required by OSHA to ensure employee safety

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