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.
