Position Overview:
The Clinical Research Nurse provides specialized nursing care and clinical coordination for participants enrolled in clinical trials. This role is responsible for screening, enrolling, and supporting patients throughout study participation while ensuring patient safety, protocol compliance, and adherence to regulatory requirements. The nurse serves as a key liaison between patients, investigators, and research teams, supporting both high-quality patient care and the successful execution of clinical research studies.
Key Responsibilities:
• Patient Care & Study Coordination
o Screen and enroll patients in accordance with clinical trial eligibility requirements.
o Provide direct nursing care, including phlebotomy, IV placement, EKGs, and other procedures within scope of practice.
o Monitor subjects for changes in condition, adverse events, protocol adherence, and response to interventions.
o Support patient retention by fostering a positive and compliant trial experience.
• Documentation & Compliance
o Ensure accurate, timely documentation in source records, case report forms, and sponsor electronic data capture systems.
o Collaborate with investigators and study staff to maintain compliant records and protocol tools.
o Participate in the development and maintenance of approved source documents and study materials.
• Regulatory & Protocol Management
o Assist with regulatory documentation and ensure compliance with institutional, sponsor, and IRB requirements.
o Support site initiation visits, monitoring, and audits.
o Contribute to feasibility analyses and program development with investigators.
• Recruitment & Informed Consent
o Pre-screen, recruit, and consent participants in collaboration with the Principal Investigator.
o Maintain and submit screening logs to sponsors as required.
• Team Collaboration & Training
o Educate and collaborate with ancillary staff, sub-investigators, and clinical teams regarding study requirements.
o Participate in continuous quality improvement initiatives to enhance trial performance and patient outcomes.
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