How you’ll spend your day
Ensure sufficient, qualified, trained and experienced staffs are available to perform the activities.
Ensure that staffs are trained on SOPs, revised SOPs and protocol before performing activities. Also implement and ensure all the activities are performed in compliance with SOPs and Protocol.
Ensure that all the instruments are calibrated as per the calibration schedule in coordination with GLP engineer.
Coordinating with Pathology Lab., QA department, statistician, accounts department and other concerned departments for smooth and planned execution of clinical studies or as per need.
Review of study documents to ensure adherence to required SOPs and regulatory requirement
Preparation & review of study documents such as e-CRF, Study plan, Study update, Clinical tables, SDTM, etc.
Responsible for maintenance of ICU and cardiac ambulance including the inventory and calibration of the instruments.
Your experience and qualifications
B.Sc. (Nursing), M.Sc. (clinical research), B. Pharm. or M. Pharm
8 to 10 years Nursing experience in BA/BE CRO.