Work in Qaqc/ Qc-clinic department @ Cliantha Research Limited
BASIC SKILLS AND ABILITIES: Knowledge of GCP, ICH E3 and Regulatory Guidelines.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Online monitoring of studies to ensure that studies are conducted in accordance with GCP, SOPs, Protocol and regulatory guidelines.
Review 100% of clinical raw data for completeness, accuracy, and for compliance with the Study Protocol, GCP, SOPs and applicable Regulatory Guidelines.
Review of Clinical Study Report as per ICH (E3), protocol, clinical raw data, sponsor and regulatory requirements.
Reconciliation and accountability of issued forms for specific studies.
Preparation of projects for QA audit and Archiving.
Review of Quality Control-Clinic SOPS
Issuance of Forms
QC Checks of Randomization and actual time point data prepared by PKBS
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