Pushparaj Singh H

Clinical Research Associate @Apotex India

Bengaluru, IN

Plan and coordinate Protocol training, Delegation log and study check-in activities in collaboration with the Principal Investigator and study coordinator- Prepare and compile essential study documents in TMF i.e, raw data, study schedules, visit dates, study forms and templates from DMS Software- Ensuring the instruments used for the clinical trial are timely calibrated and routinely maintained- Ensure all document compliance with ALCOA++ principles of ICH-GCP- Tracking & Updating the CV of PI, Co-I, CI and Physicians on ACLS & BLS trainings- Review subjects’ registration, screening, check in and checkout details in Nuleap software and ensuring timely updates- Ensure study activities are conducted in compliance with the protocol and SOP guidelines- Tracking on medical supplies and Inventory based on requirements- Track protocol deviations, AE and SAEs in the study using Quality Management System (QMS) with the protocol requirement- Support during internal, Quality assurance and corporate audit.

Rajiv Gandhi University of Health Sciences

M.Pharm

Govt PU College For Boys Malleshwaram 18th Cross

Science

DM Public School

School

Rajeev Gandhi Memorial School

High School

East West College Of Pharmacy

Bachelor of Pharmacy - BPharm