Registered Nurse Advanced

Job Summary

Responsible for advanced nursing activities such as, but not limited to, Informed Consent documentation, medical history, AE/CM, drug administration/accountability, dose verification, focused subject physical assessments, collaborate with the medical team, IV placement, IV infusions, vital signs, ECG lead placement in the conduct of clinical trials with emphasis on the safety and welfare of study participants. Performs the practical activities of clinical studies according to protocol, regulatory requirements, SOPs, scope of practice and current training status.

• With supervision, ensures that clinical trials are conducted according to protocol requirements by utilizing the following techniques & procedures.
• Ensures subject has complete understanding of study‑specific Informed Consent Form and that all questions have been answered. Accurately documents and records completion of Informed Consent.
• Obtains and accurately documents structured subject medical, surgical and medication history.
• Performs meal administration, ensuring the correct meal and correct content is delivered to the correct study participant.
• Performs subject bag checks to ensure no contraband is present on study floor.
• Performs study activities such as ECG positioning, exercises, or other study procedures requiring supervision of subjects.
• Performs venipuncture, capillary, and/or IV specimens from study subjects according to established protocol, maintains aseptic technique.
• Performs proper and accurate sample management, including collection, identification, transport, and/or processing of biological (blood, urine, etc.) subject samples.
• Administers study drug and any other protocol‑required medications, while accurately ensuring the 5 Rights of Medication Administration (the right subject, the right drug, the right dose, the right route, and the right time).
• Performs dose verification, assisting other Clinical Research Nurses during dose administration to accurately verify subject identity and dosing labeling, as additional quality check.
• Contributes and is accountable for secure and appropriate storage of all drug supplies after removing from pharmacy.
• Records subject Adverse Events with proper escalation to medical or Charge Staff for evaluation and treatment as warranted.
• Performs and records physical measurements including height, weight, and BMI calculation.
• Performs and records vital sign measurements (blood pressure, pulse oximetry, heart rate, temperature, respirations, etc.).
• Places ECG electrodes and leads accurately to ensure precise telemetry monitoring.
• Performs additional task list items as delegated and supervised by Charge Staff.
• Reviews Study Specific Trainings and applicable protocols for a thorough understanding of the study procedures, as they apply to their role and ensures that Delegation of Authority/Training Log for each study is completed in a proper and timely manner.
• Keeps abreast of SOPs, Good Clinical Practice (GCP) and ICH guidelines, state and national laws and ethical standards.
• Observes and maintains all HIPAA, OSHA, and Exposure Control regulations and Emergency Response as required by applicable training.
• Creates and maintains accurate records of all protocol activities and events, as delegated and trained.
• Follows progress of volunteers and provides for their care, comfort and safety by attending to their needs during study participation.
• Participates in quality assurance of clinical research projects and initiates the need for same as it impacts on clinical practice.
• As required for study or site needs and if trained and delegated may be assigned study procedures such as obtaining participant information/histories/questionnaires/meals/vital signs/EKGs/drug administration/specimen collection/luggage searches.

• Keeps abreast of SOP’s, ICH/GCP guidelines, NIH guidelines, as well as state and national regulatory requirements.
• Maintains calm, professional atmosphere on study floor, leading by example with professional resolution of conflict and appropriate delegation.
• Ensures that Study Manager and Clinical Floor Supervisors are…