Job Abstract

The Clinical Research Nurse II (CRN II) is responsible for providing research services to patients participating in clinical trials within the Yale Cancer Center Clinical Trials Office, while ensuring safe, compliant, efficient, and effective conduct of clinical trials.

Key responsibilities include planning, tracking, and ensuring that the clinical activities for study participants are conducted in accordance with approved protocols. These activities include, but are not limited to patient screening, eligibility determination, registration and other protocol and subject milestones. The CRN II will have direct patient contact and is responsible for managing and performing the clinical and operational aspects of moderately to highly complex protocols. Knowledge of Food and Drug Administration (FDA) regulations, Good Clinical Practice (GCP) guidelines, and other applicable federal regulations. 1. Coordinates, implements, and evaluates all aspects of clinical trial conduct including study initiation, execution/maintenance, completion, and administration for moderately to highly complex protocols.2. Assists study feasibility reviews.3. Adheres to study protocol, maintains accurate documentation, recruits study participants, and ensures regulatory and protocol requirements and guidelines are met per ICH/GCP, federal regulation, and institutional and sponsor requirements.4. Identifies instances of noncompliance and deviations from protocol and reports noncompliance and deviations to the appropriate parties.5. Builds, reviews, and approves accurate and complete order sets to ensure compliance with individual research protocols. Reviews Beacon order set with CRC in anticipation of upcoming participant’s clinic visit. Pends orders for routing to Investigator for approval and signature.6. Assists in ensuring Principal Investigator oversight by providing updates on protocol issues, obtaining signatures and clinical significance on lab reports, ECGs, adverse events, and other documents as required.7. Develops and participates in the delivery of training for new protocols, including the creation of training materials, protocol-specific tool kit, nursing in-service presentations and others as required by specific protocols. Determines the appropriate training delivery mechanism, timing, and frequency.8. Performs direct patient care (clinical and non-clinical assessments) including, but not limited to electrocardiograms and administration of research instruments per study protocol requirements.9. Maintains the integrity of the clinical research study by striving to advocate for patients and families. Serves as clinical resource for triaging and addressing research related inquiries generated from YCC websites and professional presentations.10. Provides patient education and medical information to study participants and families to ensure understanding of proper medication dosage, administration, and side effects, when appropriate.11. Serves as front line medical person in interpreting protocol to medical and nursing staff, particularly concerning dose medications and safety issues related to the administration of the study drug or treatment.12. Participates in monitoring visits, and external audits (e.g., sponsor, FDA) to ensure smooth and positive process and outcome.13. Tracks and reports adverse events, serious adverse events, protocol waivers, deviations, and violations.14. Performs other duties as assigned. Graduate of an accredited nursing program and minimum three (3) years of related nursing experience in a hospital, clinic, or similar health care setting required or 3 years of clinical research nurse experience, or equivalent combined experience, or the equivalent combination of education or experience. Experience must indicate the ability to work with minimal supervision in a team environment.