Clinical Study Infusion Nurse

Position Title:
 
Clinical
Study Infusion Nurse / Clinical Research Infusion Nurse

Job Summary:

The Study Infusion Nurse is a registered nurse with specialized skills in intravenous (IV) therapy and clinical trial procedures. Under the direct supervision of the Principal Investigator (PI) and in close collaboration with the Clinical Study Coordinator, the Study Infusion Nurse is responsible for the safe and precise administration of investigational products and other study-related medications. This role ensures that all infusion procedures adhere strictly to the study protocol, Good Clinical Practice (GCP) guidelines, and all applicable Philippine regulations.

Key Responsibilities:

• Clinical Procedure Execution:
• May assist in preparation and administration of investigational products and other IV medications according to the study protocol and physician's orders.
• Performs venipuncture and other vascular access procedures, including the insertion and maintenance of peripheral IV lines, PICC lines, and other central venous access devices.
• May assist in calculation and verification of medication dosages based on patient weight, body surface area, and other protocol-specific parameters.
• Maintains a sterile field and strictly adheres to aseptic techniques to prevent infection.
• Patient Monitoring and Safety:
• Conducts comprehensive pre-infusion, during-infusion, and post-infusion patient assessments, including taking vital signs and evaluating for any adverse reactions or side effects.
• Immediately identifies, manages, and reports any infusion-related complications, such as extravasation, allergic reactions, or anaphylaxis, to the PI and the research team.
• Provides ongoing comfort and support to participants during the infusion process, addressing their concerns and ensuring a positive experience.
• Educates patients and their caregivers on the infusion process, potential side effects, and self-care techniques.
• Documentation and Data Integrity:
• Maintains accurate, timely, and complete documentation of all infusion-related activities in the patient's source documents and the study's Case Report Forms (CRFs) or Electronic Data Capture (EDC) system.
• Assists in the management and reconciliation of the inventory of investigational products, ensuring proper storage, dispensing, and accountability in accordance with the protocol and regulatory requirements.
• Assists the Clinical Study Coordinator in preparing for monitoring visits and audits by providing clear and well-organized documentation.
• Collaboration and Communication:
• Collaborates effectively with the PI, Clinical Study Coordinator, pharmacists, and other members of the research team to ensure a seamless workflow.
• Communicates any patient status changes, protocol deviations, or other critical information to the PI and the research team in a timely manner.
• Participates in site initiation visits and provides input on the feasibility of infusion-related procedures at the site.

Qualifications and Requirements

Education and Licensure:

• Required:
   Bachelor of Science in Nursing (BSN) from an accredited university.
• Required:
   A valid and active Registered Nurse (RN) license from the Professional Regulation Commission (PRC) of the Philippines.

Experience:

• Required:
   At least 2-3 years of clinical nursing experience, with a significant portion of that time dedicated to IV therapy, critical care, or a related specialty (e.g., oncology, emergency room).
• Preferred:
   Prior experience as a study nurse, clinical research coordinator, or in a clinical trial setting is highly desirable. Experience with specific therapeutic areas relevant to the study (e.g., oncology, rheumatology, infectious diseases) is a strong advantage.

Knowledge and Skills:

• Infusion Expertise:
   Exceptional technical skills in venipuncture, IV catheter insertion, and the management of various vascular access devices.
• Drug administration:
   knowledge of pharmacology, medication administration, and drug interactions, particularly with investigational products.
• Regulatory Knowledge:
   Strong understanding of ICH-GCP guidelines and Philippine clinical trial regulations (e.g., from the FDA).
• Patient Care:
   A compassionate and patient-centric approach with a focus on participant comfort and safety.
• Critical Thinking:
   The ability to quickly and accurately assess patient conditions, identify potential risks, and respond effectively to emergencies.
• Documentation:
   Meticulous attention to detail and a high level of accuracy in all documentation and record-keeping.
• Communication:
   Excellent communication skills in both English and Filipino, with the ability to explain complex medical information clearly to participants.
• Certification:
   with an active GCP training certificate in the last 2 years. Other relevant certifications like Basic Life Support (BLS) and Advanced Cardiac Life Support (ACLS) are often mandatory.