The Research Nurse ensures the safe, ethical, and compliant delivery of clinical trials by providing exceptional nursing care to study participants at every stage of the research process — safeguarding their wellbeing while upholding the scientific and regulatory integrity that makes Astrum's clinical research trustworthy and impactful.
Complies with all applicable legal, ethical, and regulatory requirements, Standard Operating Procedures (SOPs), and business ethics standards.
Verifies the equipment and supplies in the emergency cart.
Assists with the setup, operation, and maintenance of equipment and instruments used in research nursing.
Provides nursing care during participant screening.
Provides nursing care to study participants and performs tasks assigned by the Principal Investigator in accordance with the Clinical Study Protocol (CSP) and applicable SOPs.
Conducts clinical follow-up with study participants throughout the study and promptly reports any clinical events to the Principal Investigator or Research Physician and the Clinical Shift Manager.
Handles investigational product(s) in accordance with the CSP and applicable written procedures.
Ensures that study participants comply with study restrictions and completes all operational tasks specified in the clinical study operational plan or assigned by the Clinical Shift Manager.
Ensures that all documentation under the Research Nurses’ responsibility is complete, current, and continuously ready for monitoring, audits, and inspections.