2023年临床研究岗位职责(20篇).docx

2023年临床研究岗位职责(20篇) 书目 第1篇临床探讨监查岗位职责 第2篇临床探讨生岗位职责 第3篇临床探讨医学岗位职责 第4篇临床探讨项目专员岗位职责 第5篇临床探讨pm岗位职责 第6篇临床探讨项目岗位职责 第7篇临床探讨员cra岗位职责 第8篇临床探讨协调岗位职责 第9篇临床探讨总监岗位职责 第10篇临床探讨项目经理岗位职责 第11篇临床探讨岗位职责 第12篇临床探讨经理岗位职责 第13篇临床探讨协调员crc岗位职责 第14篇临床探讨监查员cra岗位职责 第15篇临床探讨助理岗位职责 第16篇临床探讨监查员岗位职责 第17篇临床探讨运营岗位职责 第18篇临床探讨员岗位职责 第19篇药物临床探讨岗位职责 第20篇临床探讨协调员岗位职责 临床探讨监查岗位职责 临床探讨监查员cra 上海百利佳生医药科技有限公司 上海百利佳生医药科技有限公司,百利佳生 position description: the clinical research associate (cra) is responsible for managing and monitoring the conduct of clinical projects according to ich-gcp, standard operating procedures (sop) and applicable project management plan (pmp) and local regulatory requirements. responsibilities: contribute comments/input in the development of protocol, informed consent form (icf), case report forms (crf) and other project related documents. evaluation potential sites with the assistance from the senior cra, pm or line manager and provide pm with recommendations for selection of qualified sites. prepare the package for institutional review boards (irb) and local regulatory authority submissions and obtain irb/regulatory approvals for conducting the clinical trial. assist pm in start-up meeting. prepare and manage the clinical trial agreements with investigators/sites. track, manage and control the site budget and expenses within approved budget and in line with the project milestones as requested. manage/coordinate the investigational products and clinical trial materials for the sites in compliance with regulatory requirements. monitor and report the project status at the sites in a timely manner. key contact person for the communication between the sites and study team. prepare, arrange and conduct the training of site personnel. conduct site initiation, monitoring and site close-out visits in compliance with monitoring plan, ich-gcp, sops, local regulations and other applicable project-specific plans. prepare monitoring report according to the sop. assist the investigator for auditing/inspection of project. coordinate with the sites to ensure all adverse events and follow-up are appropriately reported and reconciled according to regulations. identify, analyze and resolve the issues at the investigator sites. qualifications: a 1-year bs (bachelor of science) degree or equivalence experience. advanced degree is a plus. at least 1 year experience in clinical research environment. good command of written and spoken in english or other second language. good organization and communication skills. high attention to detail and accuracy. 临床探讨生岗位职责 medical advisor 岗位职责: 1、负责肿瘤领域产品的医学支持,供应专业的医学观点 2、批阅、批准产品说明书和推广材料,确保它的科学性和精确性,确保它遵守公司sop和中国的法规 3、收集医学资料和信息,为内部和外部客户处理解答相关医学领域的问题 4、医学专家数据库的建立与管理维护 5、对医药代表进行相关疾病及产品学问培训 6、帮助文章发表 7、帮助实施上市后临床试验 8、与临床探讨团队、市场部、销售部、注册部等部门亲密合作,供应强有力的医学支持 任职要求: - 临床医学专业探讨生毕业 - 2-3年cro或外资制药公司医学部、临床探讨部工作阅历,或者有医院工作阅历 - 具有较强的合规意识 - 沟通实力强,工作主动主动 - 较好的英文阅读、书写、翻译实力 - 良好的团队合作意识 - 熟识常用办公软件(microsoft word, excel,powerpoint等),熟识幻灯片的制作 岗位职责: 1、负责肿瘤领域产品的医学支持,供应专业的医学观点 2、批阅、批准产品说明书和推广材料,确保它的科学性和精确性,确保它遵守公司sop和中国的法规 3、收集医学资料和信息,为内部和外部客户处理解答相关医学领域的问题 4、医学专家数据库的建立与管理维护 5、对医药代表进行相关疾病及产品学问培训 6、帮助文章发表 7、帮助实施上市后临床试验 8、与临床探讨团队、市场部、销售部、注册部等部门亲密合作,供应强有力的医学支持 任职要求: - 临床医学专业探讨生毕业 - 2-3年cro或外资制药公司医学部、临床探讨部工作阅历,或者有医院工作阅历 - 具有较强的合规意识 - 沟通实力强,工作主动主动 - 较好的英文阅读、书写、翻译实力 - 良好的团队合作意识 - 熟识常用办公软件(microsoft word, excel,powerpoint等),熟识幻灯片的制作 临床探讨医学岗位职责 临床探讨高级医学经理 临床探讨高级医学经理 工作职责: 1、全面负责临床试验项目临床方案、病例报告表等相关资料的撰写、审核及修订工作 2、全面负责临床试验的临床总结报告、临床探讨综述等临床部分申报资料的撰写、审核及修订工作 3、负责临床试验醒目开展过程中的临床学术支持工作的统筹管理与技术把关 4、依据临床项目的需求与临床医学转接、审评专家进行临床方案设计相关的沟通 5、临床探讨今夕过程中的技术支持与说明,与探讨者建立良好沟通,促进项目的顺当进行 6、负责药物平安性管理,供应相关学术支持 7、就临床探讨相关医学背景学问对临床探讨相关内部和外部人员进行培训 8、搜集区域内医学前沿信息及帮助公司对外学术信息的沟通 9、为公司新药立项、新药临床学术推广供应临床学术支持。 10、其他协作部门领导支配的工作。 职位要求 1、临床医学、基础医学等相关专业,本科及以上学历 2、3年以上药物临床探讨工作阅历,医学写作阅历,有临床医生工作阅历者优先 3、英语6级以上,口语、读写实力佳,能够和英语母语人员进行口头及书面沟通; 4、有较强的医学英语写作基础,能够独立完成英文医学文件的翻译写作项目; 5、良好的组织协调实力、具备较强的团队合作精神; 6、有精彩独立工作实力和项目管理实力; 7、有很强的沟通实力和人际交往实力,能够和客户形成良好的互动,建立互信的合作关系; 8、具有敏锐的视察力和逻辑分析实力,关注细微环节,时间观念强, 9、具有良好的适应实力,能在时间限制和任务压力下工作。 临床探讨高级医学经理 工作职责: 1、全面负责临床试验项目临床方案、病例报告表等相关资料的撰写、审核及修订工作 2、全面负责临床试验的临床总结报告、临床探讨综述等临床部分申报资料的撰写、审核及修订工作 3、负责临床试验醒目开展过程中的临床学术支持工作的统筹管理与技术把关 4、依据临床项目的需求与临床医学转接、审评专家进行临床方案设计相关的沟通 5、临床探讨今夕过程中的技术支持与说明,与探讨者建立良好沟通,促进项目的顺当进行 6、负责药物平安性管理,供应相关学术支持 7、就临床探讨相关医学背景学问对临床探讨相关内部和外部人员进行培训 8、搜集区域内医学前沿信息及帮助公司对外学术信息的沟通 9、为公司新药立项、新药临床学术推广供应临床学术支持。 10、其他协作部门领导支配的工作。 职位要求 1、临床医学、基础医学等相关专业,本科及以上学历 2、3年以上药物临床探讨工作阅历,医学写作阅历,有临床医生工作阅历者优先 3、英语6级以上,口语、读写实力佳,能够和英语母语人员进行口头及书面沟通; 4、有较强的医学英语写作基础,能够独立完成英文医学文件的翻译写作项目; 5、良好的组织协调实力、具备较强的团队合作精神; 6、有精彩独立工作实力和项目管理实力; 7、有很强的沟通实力和人际交往实力,能够和客户形成良好的互动,建立互信的合作关系; 8、具有敏锐的视察力和逻辑分析实力,关注细微环节,时间观念强, 9、具有良好的适应实力,能在时间限制和任务压力下工作。 临床探讨项目专员岗位职责 临床探讨经理-项目经理-主管-专员 main tasks & responsibilities 1. contribute country specific aspects in the development of protocol, protocol revisions, amendments and crf design; 2. responsible for the management of designated sites in clinical trial including: l site assessment;l preparation of the monitoring plan and execution in compliance with visit frequency and all assigned tasks throughout the study;l planning and execution of study logistics plan, including eventual delegation of activities to support group;l safety and proper conduct throughout the trial. 3. site specific data management; 4. prepare documentation for irb/ec submission/approval, together with study management per country specific requirements; 5. prepare and review clinical study agreements and budgets with study manager and contracts group; 6. ensure procedures are in place for appropriate enrollment of patients into the clinical trial; 7. organize investigators start-up meeting and study site initiation meetings, including training of the external study personnel in the use of the instruments and reagents and software packages for the on-line data capture and for the computer based e.g. with wincaev and training in the use of electronica crfs with remote data entry;8. responsible for instrument installation, check and validation (internal and external) for system study. if applicable, prepare workflow sheet for system studies, together with study management; 9. responsible for logistics of required evaluation/clinical trial material. informs and monitors sites for correct storage conditions; 10. preparation of all study binders; 11. perform investigator training (compliance & technical part). 12. verify the investigator follows the approved protocol and all gcp procedures; 13. verify all research staff and facilities have adequate qualifications and resources remain adequate throughout the duration of the study; 14. key contact for communications between the sponsor and the investigator; the point of first contact when investigators/site personnel enquire about patient inclusion/exclusion criteria for ongoing trials; 15. ensure that observations during studies are correctly tracked and forwarded to the responsible departments in xxxx; 16. verify that source data/documents and other trial records are accurate, complete, and maintained. regarding the result calculations: ensure the usability of validated computer programs/software and result calculation in compliance to applicable sops;17. communicate deviations from the protocol, sops, gcp, and the applicable regulatory requirements to the investigator; 18. interprets and evaluates results with respect to the study goals and, if necessary, discuss with the site, the study manager, eg. interruption of the study or initiation of additional measurements at the external site; 19. perform troubleshooting for unexpected results according to study manager or protocols requirements; 20. ensure completion and availability of study documentation, together with study management;21. adverse events, concomitant medications, and inter current illnesses are reported in accordance with the protocol;22. conduct study close-out visits according to monitoring plan; 23. ensure ecrf and wincaev are ready for database lock; 24. archive study records / database according to guidelines; 25. responsible for post study sample/reagents/investigational use products/instruments disposition completed during the close-out visit;26. participation in project teams, global conference calls and/or meetings to review progress of ongoing clinical trials and to assess development of new projects regarding customer usability, practicability and sop development, to continuously improve quality and efficiency of the evaluation team and processes; 27. contribute to the content of the study report and contribute to publications for journals and congresses. possible additional tasks for senior position holders; 28. responsible for investigator selection (accountability lies with study manager) 29. provide mentoring, including training on the job, to the new cras to ensure that their role and contribution is optimized. basic requirements of the job 1. bio-medical related scientific degree; can vary from a bachelor, master and nursing qualifications; 2. knowledge of applicable standards an regulations for clinical trials and lab conduct (international conference on harmonization / who good clinical practice standards (ich-gcp), ivd directives, fda regulations) 3. practical experience in study monitoring according to global standards (ich) 4. 2-5 years of clinical laboratory experience; 5. demonstrated experience in computer skills to include microsoft word, excel, and basic templates; 6. basic statistical knowledge; 7. professional use of the english language; both written and oral; 8. open and clear communicator; 9. ability to make sound decisions and analyze and solve problems; 10. conscientious and precise delivery of work even when under pressure jd 为参考。经理-专员各级别都有。 背景优先级:1 ivd 2 cro 3 器械 4 药 main tasks & responsibilities 1. contribute country specific aspects in the development of protocol, protocol revisions, amendments and crf design; 2. responsible for the management of designated sites in clinical trial including: l site assessment;l preparation of the monitoring plan and execution in compliance with visit frequency and all assigned tasks throughout the study;l planning and execution of study logistics plan, including eventual delegation of activities to support group;l safety and proper conduct throughout the trial. 3. site specific data management; 4. prepare documentation for irb/ec submission/approval, together with study management per country specific requirements; 5. prepare and review clinical study agreements and budgets with study manager and contracts group; 6. ensure procedures are in place for appropriate enrollment of patients into the clinical trial; 7. organize investigators start-up meeting and study site initiation meetings, including training of the external study personnel in the use of the instruments and reagents and software packages for the on-line data capture and for the computer based e.g. with wincaev and training in the use of electronica crfs with remote data entry;8. responsible for instrument installation, check and validation (internal and external) for system study. if applicable, prepare workflow sheet for system studies, together with study management; 9. responsible for logistics of required evaluation/clinical trial material. informs and monitors sites for correct storage conditions; 10. preparation of all study binders; 11. perform investigator training (compliance & technical part). 12. verify the investigator follows the approved protocol and all gcp procedures; 13. verify all research staff and facilities have adequate qualifications and resources remain adequate throughout the duration of the study; 14. key contact for communications between the sponsor and the investigator; the point of first contact when investigators/site personnel enquire about patient inclusion/exclusion criteria for ongoing trials; 15. ensure that observations during studies are correctly tracked and forwarded to the responsible departments in xxxx; 16. verify that source data/documents and other trial records are accurate, complete, and maintained. regarding the result calculations: ensure the usability of validated computer programs/software and result calculation in compliance to applicable sops;17. communicate deviations from the protocol, sops, gcp, and the applicable regulatory requirements to the investigator; 18. interprets and evaluates results with respect to the study goals and, if necessary, discuss with the site, the study manager, eg. interruption of the study or initiation of additional measurements at the external site; 19. perform troubleshooting for unexpected results according to study manager or protocols requirements; 20. ensure completion and availability of study documentation, together with study management;21. adverse events, concomitant medications, and inter current illnesses are reported in accordance with the protocol;22. conduct study close-out visits according to monitoring plan; 23. ensure ecrf and wincaev are ready for database lock; 24. archive study records / database according to guidelines; 25. responsible for post study sample/reagents/investigational use products/instruments disposition completed during the close-out visit;26. participation in project teams, global conference calls and/or meetings to review progress of ongoing clinical trials and to assess development of new projects regarding customer usability, practicability and sop development, to continuously improve quality and efficiency of the evaluation team and processes; 27. contribute to the content of the study report and contribute to publications for journals and congresses. possible additional tasks for senior position holders; 28. responsible for investigator selection (accountability lies with study manager) 29. provide mentoring, including training on the job, to the new cras to ensure that their role and contribution is optimized. basi