绍国 王

• Prepare and conduct new hire training and continually improve training for staff on PRAHS/ICON expectations, systems, SOPs, etc. • Conduct trending analyses on data collected through QC activities and identify areas of potential training needs. • Provide compliance support by answering questions or providing advice on ICH/GCP, SOPs, local regulations and guidelines. • Conduct Quality Control activities on selected service areas as needed to assess quality deliverables. • Responsible for drafting and/or maintaining a Quality & Training Plan for an assigned program. • Provide fundamental trainings of ICH GCP and drug development process, monitoring skill training, CTA skill training, SOPs training, etc. for employees in CRA/SAM/CTA/SSU, etc. in the entire Asia-Pacific region in English, and regularly update related courses according to SOP/ regulations. • 任PRA Quality & Training Development部门Quality & Training Advisor一职，汇报给亚太区菲律宾籍经理，执行中国区Quality Oversight访视，进行质量控制活动并评估CRA的监查能力，根据质控评估结果提供CAPA建议，与CRA的LM沟通，为CRA提供ICH-GCP基础培训、监查技能培训、肿瘤临床试验基础知识培训，并定期主持软技能分享讨论会，确保CRA具备较好的GCP意识、掌握必要的监查技能，解答CRA与ICH-GCP、当地法规以及SOP相关的问题，并提供相关的建议。 • 后期并入ICON University培训部门，转变为纯英文工作内容，汇报给全球团队法国籍培训经理，使用英文为整个亚太地区CRA/SAM/CTA/SSU等临床运营相关岗位员工提供ICH-GCP基础培训、监查技能培训、CTA技能培训、公司SOPs培训等，并定期根据SOP/法规变化，负责相关课程的更新工作。

As a contractor CRA to J&J, participate in three clinical trials, responsible for site assessments/selection visits, initiation visits, interim monitoring visits, etc. 外派强生（中国）投资有限公司/西安杨森，任Global Clinical Operation部门Sr. Site Manager/CRA，参与多项临床试验。主要负责相关项目的中心筛选、调研、启动及启动后中心管理、监查等相关工作。

Participate in three clinical trials, responsible for site assessment/selection, contract negotiation, initiation visits, interim monitoring visits, etc. Provide trainings to all site staffs about protocols, SOPs and other trial related documentations at site initiation visits, interim monitoring visits or when any trial related documents updates. And sharing trial operation experience to team members at project meetings. As a mentor of CRA trainees, teach them how to perform different visit types and share work experience to them. 任临床研究部监查员，主要从事肿瘤相关领域临床研究监查工作。主要负责相关项目的中心筛选、调研、合同谈判、启动及启动后中心管理、监查等相关工作。

Formulating appropriate audit plans. Inspecting all phases and aspects of the clinical trial, including ISF, medical record, CRF, management of investigational products/biological samples, informed consent, AE/SAE, etc. Communicating with the investigator or the CRA to learn the relevant situations and provide solutions on solving issues. Writing audit reports and following CAPA status after visits. Collaborating with the clinical research department, helping to rectify problems before the inspection. Cooperating with experts of NMPA for on-site inspection. 任临床质量保证部稽查员一职，负责制定稽查计划，执行中心现场稽查工作：核查ISF、知情同意过程、受试者病历/CRF、AE/SAE、研究药物管理以及溯源数据等，就稽查出的问题同研究人员及监查员沟通讨论，撰写稽查报告，跟进后续问题整改情况并提供审核意见。 支持项目启动会，制定、审核SOP，收集整理更新的法律法规信息。 国家局现场核查现场支持及协助临床运营部门核查前自查整改相关工作。