职责要求：
Drive performance at the sites. Perform site monitoring and other onsite visit activities according to monitoring plan and in compliance with procedural documents . Provide the required monitoring visit reports within required timelines. Proactively identify study-related issues and escalates to Local Study Teams as appropriate.
Contribute to the selection of potential investigators. Train, support and advise Investigators and site staff in study related matters.
Obtain and maintain essential documentation in compliance with ICH-GCP, Procedural Documents and local regulations. Manage study supplies (ISF, CRF, etc), drug supplies and drug accountability at study sites.
Perform source data verification according to SDV plan. Ensure data query resolution. Work with data management to ensure quality of the study data.
Ensure accurate and timely reporting of Serious Adverse Events.
Share relevant information on patient recruitment and study site progress within local Study Team. Update VCV and other systems with data from centres as per required timelines
Prepare for activities associated with audits and regulatory inspections in liaison with local Study Delivery Team Lead and QA.
任职资格：
Bachelor degree in biological science or healthcare-related field, or equivalent
Minimum 2-year experience as CRA or other related fields. Experience as a clinical monitor, performed all tasks for a CRA position.
Knowledge of the Monitoring Process, such as understanding of the Study Drug Handling Process and the Data Management Process, etc.
Understanding of the clinical dataflow
Solid knowledge of the clinical study and drug development processes, GCP/ICH guidelines and relevant local regulations
Good computer skills in Microsoft and other software.
Fluent in both oral and written English.
Proficient written and verbal communication skills, collaboration and interpersonal skills.