What are the responsibilities and job description for the Clinical Research Nurse position at Medix™?
Under the guidance of the Principal Investigator, the Clinical Research Nurse Specialist II is responsible for coordinating and managing oncology clinical trials from patient screening through study completion. This role ensures studies are conducted in accordance with Good Clinical Practice (GCP), FDA regulations, sponsor requirements, and institutional policies while providing exceptional patient care throughout the research process.
Key Responsibilities
- Coordinate oncology clinical trials from screening, enrollment, randomization, and study completion.
- Recruit, screen, consent, and educate study participants.
- Perform protocol-specific study procedures, assessments, medication administration, and laboratory coordination.
- Monitor participants for adverse events and ensure timely reporting to investigators, sponsors, and regulatory agencies.
- Maintain accurate source documentation and ensure compliance with GCP, IRB, FDA, and institutional guidelines.
- Prepare and maintain regulatory documents, including IRB submissions, amendments, and continuing reviews.
- Coordinate sponsor monitoring visits, site audits, and study-related communications.
- Collect, package, and ship study specimens according to protocol and IATA guidelines.
- Collaborate with physicians, research staff, and sponsors to ensure successful execution of clinical trials.
- Utilize nursing expertise to provide safe, patient-centered care while maintaining protocol compliance and data integrity.
Salary : $40 - $45