Conducts source data verification (SDV) and ensures clinical trial data are submitted to data management in a timely fashion
Identifies issues that may impact on the conduct of the study and ensures appropriate closure of all issues
Proactively manages a greater investigator site workload commensurate with experience, so that studies are run efficiently, and key study objectives are met
Ensures studies are run in line with ICH/GCP, local laws and Client Standard Operating Procedures (SOPs)
Ensures patient safety is maintained and all safety issues are reported correctly according to all relevant local and international regulatory requirements
Informs the Principal Investigator (PI) and site staff of all issues
Agrees and develops corrective and preventative actions with PI and site personnel to close all open issues
Responsible for all aspects of site management from collaboration on site selection to study closeout
Trains site staff on the protocol, protocol amendments and Client processes
Maintains accurate site-level information on corporate clinical trials registry

At least 1.5 years (2 years preferable) of Clinical Monitoring/ Site Management experience
Good knowledge of ICH/GCP, relevant international and local regulations relating to Clinical Research
Degree in Life Science, Nursing, Pharmacy, or other relevant education background
Bachelor’s degree or above, or equivalent
Proficient in Chinese, good command of written and spoken English is required

Clinical Research Associate II – FSP

Key skills