卢女士
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- 职位介绍
- CRA
- 新药
- 药物
- 生物药
- 抗肿瘤药
- 抗癌药
- CRF
- ICF
- Responsibilities: 1、Contribute comments/input in the development of Protocol, Informed Consent Form (ICF), Case Report Forms (CRF) and other project related documents. 2、Evaluation potential sites with the assistance from the senior CRA, PM or line manager and provide PM with recommendations for selection of qualified sites. 3、Prepare the package for institutional review boards (IRB) and local regulatory authority submissions and obtain IRB/regulatory approvals for conducting the clinical trial. 4、Assist PM in start-up meeting. 5、Prepare and manage the clinical trial agreements with investigators/sites. 6、Track, manage and control the site budget and expenses within approved budget and in line with the project milestones as requested. 7、Manage/coordinate the investigational products and clinical trial materials for the sites in compliance with regulatory requirements. 8、Monitor and report the project status at the sites in a timely manner. 9、Key contact person for the communication between the sites and study team. 10、Prepare, arrange and conduct the training of site personnel. 11、Conduct site initiation, monitoring and site close-out visits in compliance with monitoring plan, ICH-GCP, SOPs, local regulations and other applicable project-specific plans. 12、Prepare monitoring report according to the SOP. 13、Assist the investigator for auditing/inspection of project. 14、Coordinate with the sites to ensure all adverse events and follow-up are appropriately reported and reconciled according to regulations. 15、Identify, analyze and resolve the issues at the investigator sites. Qualifications: 1、A 4-year BS (Bachelor of Science) degree or equivalence experience. Advanced degree is a plus. 2、At least 4 years experience in clinical research environment. 3、High attention to detail and accuracy. 4、Good organization and communication skills. 5、Good command of written and spoken in English or other second language.
- 其他信息
- 行业要求：全部行业
- 所属部门：CDR
公司简介
Novotech（诺为泰）立足亚太、面向全球，是专业的生物技术合同研究组织(CRO)。
诺为泰是家包含实验室、I期临床中心、药物开发咨询服务和专业FDA法规服务的临床CRO，拥有超5,000项临床项目经验，包括I 期至IV期临床试验。诺为泰专注于服务在亚太、美国与欧洲等地进行临床试验的生物技术客户。诺为泰目前在全球34个办公地点共拥有3000多名员工。
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