How You’ll Spend Your Day:
- Staff Management:
- Ensure availability of sufficient, qualified, trained, and experienced staff.
- Train staff on SOPs, revised SOPs, and protocols before activity commencement.
- Ensure all activities comply with SOPs and protocols.
- Instrument Management:
- Ensure all instruments are calibrated as per the schedule in coordination with the GLP engineer.
- Coordination:
- Coordinate with Pathology Lab, QA department, statistician, accounts department, and other concerned departments for the smooth execution of clinical studies.
- Document Review:
- Review study documents to ensure adherence to SOPs and regulatory requirements.
- Document Preparation:
- Prepare and review study documents such as e-CRF, study plan, study updates, clinical tables, SDTM, etc.
- Maintenance:
- Responsible for the maintenance of ICU and cardiac ambulance, including inventory and calibration of instruments.
