临床监查员 I & II
1.1-1.5万·14薪成都市本科不限经验
职位描述
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 or above in biological science or healthcare-related field, or equivalent
? Minimum
1.5-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.
? Proficient written and verbal communication skills, collaboration and interpersonal skills.
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