临床研究质量管理员

Summary
Conduct the review an******** of clinical studies to ensure researchintegrity an******** with institutional pol******** governmentregulat******** an******** guidelines.
对临床研究项目进行内部质量检查，以确保研究项目开展的合规合法。
Essential Job Function
• Perform internal audits independently to ensure all clinical researchstudies conducte******** JIH are in compliance with protocols,institutional pol******** government regulat******** an********guidelines. The audit review will include the assessment of regulatory******** trial subjects informe******** process, el******** studytreatment a******** protocol compl******** toxicity an********evaluation an********, an******** data quality.
独立进行内部质量检查，以确保在嘉会国际医院进行的所有临床研究项目均符合研究方案，机构制度和流程，政府法规和GCP指南。检查内容包括对项目文件、受试者知情同意过程及是否符合入选标准、项目相关的治疗和用药、方案依从性、毒性及应答的评估和报告、以及数据质量的评估。

• Professionally an******** communicate review findings both verballyan******** formal written reports to relevant study PI/team，directoran******** director of clinical research, an******** IRB (if necessary).
通过口头和正式的书面报告，专业有效地将检查结果传达给主要研究者及团队，机构主任、机构办主任和临床研究伦理委员会（必要时）。

• Assist principal investigator an******** team to develop appropriatecorrective an******** measures an******** continuing education whenneeded.
需要时帮助研究者及团队针对检查结果拟定相应的纠正预防措施及开展继续教育。

• Identify quality improvement opportunities an******** in thedevelopment of quality relate********, including the quality assurancepolicy an******** development.
评估质量改进的需求并参与质量相关的制度和标准操作规程的制定。


• Assist in the external audits or inspections conducte******** sponsorsor government entities. Provide the overall coordination an******** thestudy team in the preparation of external audits or inspections.
协助申办方或政府部门的稽查/视察；提供整体协调并协助研究团队做好稽查/视察的准备工作。

• Provide professional an******** staff education concerning researchquality as required.
根据需要负责对医院工作人员提供与临床研究质量保证相关的专题培训和继续教育。

• Other duties as assigned.
上级交派的其他任务。

Supervision
Received: D******** Clinical Research Office 临床研究机构办公室主任
Given: None
Education
Bachelor of Me******** Bachelor of Surgery (MBBS) or Bachelor degree inother healthcare relate********
本科及以上学历，临床医学或其他医药相关专业
Experience
Minimum of 3 years in clinical research practice; Prior years ofclinical experience preferred
至少3年临床研究相关经验；具有临床工作经验者优先。
Licensure an********
• GCP Certification
GCP 证书
• Active medical license or other healthcare relate******** license topractice in China is preferred
持有有效的执业医师证书或其他医药相关的执业证书者优先
Other Requirements
• Excellent written an******** communication skills
优秀的书面和口头沟通技能
• Fluent in Mandarin Chinese an********
流利的普通话和英语