Registered Nurse

Job Summary Responsible for basic nursing activities, including presenting informed consents, documenting medical history, adverse events, concomitant medications, performing drug administration and accountability, dose verification, focused subject physical assessments, collaborating with the medical team, IV placement and infusions, vital signs, and 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. Essential Duties and Responsibilities With supervision, ensures that clinical trials are conducted according to protocol requirements by utilizing the following techniques and procedures. Ensures the subject has complete understanding of the 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 while maintaining aseptic technique. Performs proper and accurate sample management, including collection, identification, transport, and/or processing of biological samples. Records vital sign measurements (blood pressure, pulse oximetry, heart rate, temperature, respirations). Places ECG electrodes and leads accurately to ensure precise telemetry monitoring. Administers study drug and any other protocol‑required medications while ensuring the 5 Rights of Medication Administration (right subject, right drug, right dose, right route, right time). Performs dose verification and assists other staff members during dose administration to verify subject identity and dosing labeling as additional quality checks. Contributes to 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 training 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, exposure control regulations, and emergency response procedures 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 care, comfort, and safety by attending to their needs during study participation. Participates in quality assurance of clinical research projects and initiates needs for quality improvement as it impacts 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, or luggage searches. Other functions as directed and delegated. Skills and Qualifications Ability to read, write, and interpret the English language. Portrays professionalism in all interactions at Spaulding Clinical. Good computer skills and inclination to adopt technology to maximize efficiency. Strong analytical, problem‑solving skills. Strong written and verbal communication skills. Detail oriented with good organizational traits. Self‑motivated. Results‑oriented, multi‑tasking, quick learner, responsive to urgent team needs, and shows a track record of meeting deadlines. Ability to work beyond normal work hours and various shift availability required. Ability to perform and record data entry via computer systems while conducting timed clinical procedures. Physical Demands Ability to sit, stand, walk, reach with hands and arms, and use hands and fingers to handle or feel. Ability to lift and/or move up to 25 pounds. Specific vision abilities required include clarity of vision both near and far. Ability to identify and distinguish colors. Hazards Potential for exposure to toxic or caustic chemicals. Potential for exposure to blood‑borne pathogens. Education and Experience Current RN or LPN license (graduate nurses must possess a temporary license in order to work as CRN and must obtain Wisconsin licensure within 6 months of hire). BLS and ACLS certification required within 6 months of hire or promotion date. Spaulding Clinical Research management has the discretion to hire personnel with a combination of experience and education which may vary from the above listed skills and qualifications. #J-18808-Ljbffr