- 通过规范的监查工作，确保临床试验按研究方案、ICH-GCP和其它法规要求进行；$- 规范的监查工作，包括确认临床数据的准确性和真实性；管理研究用药品和其它相关物品；管理临床试验各相关文件；$- 依据方案、SOPs和 ICH-GCP的要求，在计划时间段进行研究中心的相关工作（如，启动、监查、关闭，等）；$- 通过监察工作，维系公司和基地良好的合作关系，并及时向主管汇报相关情况；$- 确保研究信息及时报告，包括向其它研究人员和主管当局及时报告不良反应；$- 其它临床监查工作。$$职位要求：$- 医学、药学相关专业本科以上学历；$- 有意愿从事本工作；$- 书面及语言沟通表达能力强；$- 熟练的电脑操作能力，特别是OFFICE软件；$- 注重工作细节，注重团队合作，关注项目运行情况，并具有相应的分析能力；$- 能适应经常出差。$$Responsibilities: $- To ensure protocol compliance, ICH-GCP and other regulatory obligations at trial sites by standardized monitoring activities；$- To perform monitoring activities, which includes verifies the accuracy and authenticity of clinical data, manage investigational products and other trial related supplies, maintain adequate clinical trial documentation etc；$- Ensure site activities in line with milestones (i.e. startup, recruitment, closeout, etc) in compliance with protocol, SOPs and ICH-GCP；$- Ensure a smooth communication through out the studies between Taiho and sites, report related issues to the line manager in a timely manner；$- To ensure the timely reporting of study information, which includes safety reporting t relevant study team member and regulatory authorities；$- Other issues related to clinical trial monitoring.$$Qualifications:$- Bachelors Degree or above, majoring in medicine or pharmacy or related；$- Willing of work；$- Good written and verbal communications skills；$- Good computer skills，especially OFFICE software；$- Attention to details, teamwork, process improvement, analyzing information；$- Can travel frequently.