- Collect vital signs (BP, pulse, temperature, respiration rate).
- Perform ECG recordings and monitor clinical observations.
- Administer investigational products as per protocol.
- Conduct sample collection activities & IV Cannulation.
- Monitor subjects throughout the study period for safety and well-being.
- Assist investigators in conducting BA/BE studies according to approved protocols.
- Coordinate study schedules, subject visits, dosing, and sample collection timelines.
- Ensure adherence to study-specific procedures and timelines.
- Maintain accurate source documents and nursing records.
- Ensure compliance with: Good Clinical Practice (GCP), ICH Guidelines, SOPs, Regulatory requirements.
- Observe and report adverse events (AEs), reliable adverse events (SAEs), and protocol deviations.
- Provide emergency care when required.
- Label, process, store, and transport biological samples according to SOPs.
- Maintain sample accountability records and chain-of-custody documentation.