职责描述：
1、Accelerate the improvement of study quality by implementing Quality Control (QC) activities and driving quality initiatives, ensure clinical studies are conducted in compliance with ICH-GCP, Chinese GCP, other related Chinese regulations, study related Standard Operation Procedures (SOP) of the company and study protocol.
通过执行质控(QC)工作及驱动质量管理创意，促进临床研究质量的提高, 确保临床研究的实施符合ICH-GCP、中国GCP、其他中国相关法规、公司相关SOP及研究方案的要求
2、Support the development and review of study related SOPs in China. Support study teams on audit and inspection.
协助中国临床研究相关SOP的建立和审阅，支持研究团队关于稽查、检查方面的工作
3、Close collaboration with cross-functional stakeholders to track new or changes
of local regulations or process.
与跨部门相关人员紧密合作，跟踪新的当地法规/流程或其改变
4、Support Head of Clinical Quality Control to come up with annual QC plan by developing site QC plan and TMF QC plan for the studies of responsible product.
为所负责产品的研究制定研究中心质控检查计划和TMF质控检查计划，以协助临床质控负责人制定年度质控检查计划
5、Implement QC activities according to QC plan. During site QC, provide feedback and recommendation to study site staff. Provide written QC report to study team timely after finishing QC checking.
根据QC计划实施QC检查。在研究中心QC检查期间，向研究中心人员提供反馈及建议。完成QC检查后及时向研究团队提供书面QC报告
6、Conduct root cause analysis on significant inspection, audit and QC findings with study teams, provide recommendation for Corrective Action and Preventive Actions (CAPA) for study teams for quality improvement.
与研究团队协作，针对检查、稽查和QC发现的显著问题进行根源分析，向研究团队就纠正措施和预防措施（CAPA）提供建议以改善研究质量
7、Provide competent advice for study teams on study related regulations and standard procedures, support study teams to solve quality and compliance problems.
向研究团队提供关于研究相关法规和标准流程的专业意见, 支持研究团队处理质量与合规问题
8、Close collaboration with relevant functions for accelerating quality improvement and relevant functions’ being ready for GCP and GVP audit and inspection for any time.
与相关职能部门紧密协作，以促进相关职能部门的质量提高，以及能随时接受GCP和GVP的稽查和检查
9、Support the development and review of study related SOPs in China.
协助中国临床研究相关SOP的建立和审阅工作
10、Contribute to training activities, and sharing/learning from inspection, audit and QC.
支持培训活动及关于检查、稽查和QC的分享/学习
11、Grasp and understand therapeutic area specific requirements for expert QC activities.
掌握和理解治疗领域的特定要求以进行专业的QC工作

任职要求：
1、Bachelor degree or above of Medical science or related field, medical/ pharmaceutical professionals are preferred.
医学科学相关专业的学士学位或以上，医学/药学专业优先。
2、At least 3 years working experience as CRA in pharmaceutical clinical research, At least 2 years experience in quality management or project management preferred, 2 years proven training or coaching experience
具有3年或以上药物临床研究CRA的经验，2年以上质量管理或项目管理经验者优先，
2年以上培训或辅导经验。
3、Good understanding of knowledge and skills required for the successful delivery of a clinical study, e.g. ICH-GCP, Chinese GCP, other study related regulations, study management, site management, monitoring.
对成功完成临床研究所需技能和知识具备良好的理解，例如：ICH-GCP、中国GCP、其他研究相关法规、研究管理、研究中心管理及监查
4、Maintain current knowledge and understanding of regulations and industry practices in relation to clinical studies.
熟知临床研究相关的现行法规和行业惯例
5、Understands the regulatory environments and the drug development process.
了解监管环境以及药物开发过程
6、Familiar with company SOPs.
熟悉公司的SOP
7、High quality standards are applied.
采取高质量标准
8、Strong interpersonal skills, with the abilities to work with other at all levels in the company.
较强的人际交往能力，具备与不同级别员工协作的能力
9、Fluent spoken and written English.
英语口语和书写流利

其他信息
语言要求：英语、普通话
行业要求：全部行业