Registered Nurse

Job Summary

Responsible for basic nursing activities such as presenting Informed Consents, documenting medical history, adverse events (AE), concomitant medications (CM), performing drug administration/accountability, dose verification, focused subject physical assessments, collaborating with the medical team, IV placement and 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 (ICF) and that all questions have been answered. Accurately documents and records completion of ICF.
• Obtains and accurately documents structured subject medical, surgical and medication history.
• Performs venipuncture, capillary, and/or IV specimen collection from study participants according to established protocol, maintaining aseptic technique.
• Performs proper and accurate sample management, including collection, identification, transport, and/or processing of biological (blood, urine, etc.) study participant samples.
• 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.
• 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 staff members during dose administration to accurately verify subject identity and dosing labeling, as an additional quality check.
• Contributes and is accountable for secure and appropriate storage of all drug supplies after removal from pharmacy.
• Records subject adverse events with proper escalation to medical or charge staff for evaluation and treatment as warranted.
• Performs additional task list items as delegated and supervised by charge staff or supervisor.
• Reviews study‑specific trainings and applicable protocols for a thorough understanding of the study procedures, ensuring that the Delegation of Authority/Training Log for each study is completed in a proper and timely manner.
• Keeps abreast of SOPs, Good Clinical Practice (GCP), 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 the progress of study participants 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 the same as it impacts on clinical practice.
• Trains staff in processes and procedures as needed.
• 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.
• Other functions as directed and delegated.

• Ability to read, write and interpret the English language.
• Portrays professionalism in all interactions at Spaulding Clinical.
• Good computer skills; inclination to adopt technology to maximize efficiency.
• Demonstrates strong analytical, problem‑solving skills.
• Strong written and verbal communication skills.
• Detail oriented, good organizational traits.
• Self‑motivated.
• Results‑oriented, multi‑tasking, quick learner, responsive to urgent needs of the team, and shows a strong track record of meeting deadlines.
• Ability to work beyond normal work hours and various shift availability required.
• Ability…