临床试验岗位职责15篇.docx

Word版本下载可任意编辑】 临床试验岗位职责15篇 [第1篇]临床试验经理岗位职责 临床试验经理 负责器械临床项目的质量控制与管理,按时完成临床试验在国内的全面启动、执行及结束工作,并及时高效的与项目相关其他部门人员开展沟通和协调; 2、负责临床试验方案、病例报告表、知情同意书等相关文件的设计与制定,并与临床专家交流修改完善; 3、负责筛选和确定临床试验主要研究者和临床试验基地,对试验机构、费用、时间等开展评估;联络研究基地,组织临床方案在研究基地的实施; 4、负责伦理会的申请及协助临床启动会和总结会的召开; 5、负责临床试验总结报告的撰写; 6、全面负责cra及crc的招聘、带教培训及日常管理工作; 负责器械临床项目的质量控制与管理,按时完成临床试验在国内的全面启动、执行及结束工作,并及时高效的与项目相关其他部门人员开展沟通和协调; 2、负责临床试验方案、病例报告表、知情同意书等相关文件的设计与制定,并与临床专家交流修改完善; 3、负责筛选和确定临床试验主要研究者和临床试验基地,对试验机构、费用、时间等开展评估;联络研究基地,组织临床方案在研究基地的实施; 4、负责伦理会的申请及协助临床启动会和总结会的召开; 5、负责临床试验总结报告的撰写; 6、全面负责cra及crc的招聘、带教培训及日常管理工作; [第2篇]临床试验主管岗位职责 临床试验主管 瑞普生物技术 天津瑞普生物技术股份公司,瑞普生物,瑞普生物技术,瑞普 职责描述: 1、负责gcp临床试验的组织和方案执行; 2、负责整理汇总评价结果,撰写gcp临床试验评价相关材料; 3、负责gcp临床试验的协调、沟通或管理。

任职要求: 1、 硕士及以上学历,动物医学、临床兽医、药理毒理相关专业; 2、 对常规试验动物的饲养管理、动物房的消毒等环境控制和生物安全防控有较强的认知,有动物饲养或动物评价经验者优先; [第3篇]临床试验监查员岗位职责 临床试验监查员(cra) 北京凯吉特医药科技发展公司 北京凯吉特医药科技发展公司,凯吉特 岗位职责 1、根据国家gcp要求,负责临床试验的组织、实施、执行和临床监查; 2、能够独立负责并完成小型项目临床监查工作,合理分配cra的工作内容,并能够管理及带着1-2名初级临床监查员完成中小型项目; 3、负责各研究中心、申办者之间的协调与沟通,并解决与研究有关的问题; 4、准备临床试验各相关文件,协助完成临床试验总结报告; 5、保持与研究单位良好的沟通与协调; 6、根据ich-gcp及项目要求,妥善建立并管理项目文件资料系统 任职要求 1、30岁以下,具有临床医学、护理学、药学或生物医学相关专业,大学本科或以上学历; 2、具有gcp培训证书者优先; 3、具有临床监查员工作经验,熟悉临床监查员工作流程和工作内容; 4、具有较强的责任心和出色的应变能力; 5、具备较强的独立工作能力及团队合作精神; 6、有cro行业工作经验者优先考虑。

[第4篇]临床试验监查岗位职责 临床试验监查员(cra) 北京凯吉特医药科技发展公司 北京凯吉特医药科技发展公司,凯吉特 岗位职责 1、根据国家gcp要求,负责临床试验的组织、实施、执行和临床监查; 2、能够独立负责并完成小型项目临床监查工作,合理分配cra的工作内容,并能够管理及带着1-2名初级临床监查员完成中小型项目; 3、负责各研究中心、申办者之间的协调与沟通,并解决与研究有关的问题; 4、准备临床试验各相关文件,协助完成临床试验总结报告; 5、保持与研究单位良好的沟通与协调; 6、根据ich-gcp及项目要求,妥善建立并管理项目文件资料系统 任职要求 1、30岁以下,具有临床医学、护理学、药学或生物医学相关专业,大学本科或以上学历; 2、具有gcp培训证书者优先; 3、具有临床监查员工作经验,熟悉临床监查员工作流程和工作内容; 4、具有较强的责任心和出色的应变能力; 5、具备较强的独立工作能力及团队合作精神; 6、有cro行业工作经验者优先考虑 [第5篇]临床试验专员岗位职责 临床试验专员 position summary 80% fte of this position will support to clinical operation in ma function, 20% fte performs a variety of administrative support to ma senior director and ma team. key responsibilities 1. clinical trial support a. trial master file and other study related documents handling and archiving in office b. clinical trial supplies logistic supporting and tracking c. clinical trial contract including vendor contract management and supporting d. clinical trial payment supporting and tracking e. supporting on organize external and internal meetings, draft meeting minutes as needed f. setup and maintain the database(s) in clinical operation as required g. ma storage room management 2. admin support to ma senior director a. arrange business trips, including the flight tickets and hotels and visa application as needed b. logistic support for function visitor(s) in china including but not limited to visa application, hotel booking, administrative communication c. function administrative file maintenance in ma d. expense report and manage the reimbursement 3. office admin support to ma team: a. assist internal process (e.g. prpo) b. collect related information from team member and consolidate reports as needed, e.g. monthly report, etc. c. function fixed assets management d. assist in new comer on board process e. be the contact person for department activities f. assist on department meeting skills and abilities 1. customer focus and good communication skill 2. good written and spoken english 3. result oriented and self-motivated 4. teamwork spirit 5. accountable with strong ownership 6. good command of ms skill (word, excel and powerpoint) desirable 1. bachelor degree in relative disciplines, biomedical background is preferred 2. at least 2 years relative working experience 3. administrative experience in related clinical research ( international healthcare companies, or cros) is preferred position summary 80% fte of this position will support to clinical operation in ma function, 20% fte performs a variety of administrative support to ma senior director and ma team. key responsibilities 1. clinical trial support a. trial master file and other study related documents handling and archiving in office b. clinical trial supplies logistic supporting and tracking c. clinical trial contract including vendor contract management and supporting d. clinical trial payment supporting and tracking e. supporting on organize external and internal meetings, draft meeting minutes as needed f. setup and maintain the database(s) in clinical operation as required g. ma storage room management 2. admin support to ma senior director a. arrange business t。