临床监察员岗位职责职位要求.docx

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1、 临床监察员岗位职责职位要求职责描述： 岗位职责： 1 负责临床试验的详细实施和监查工作，确保工程根据国家GCP要求、试验方案和公司标准操作程序进展，做好全过程的质量掌握； 2 负责整理和完善全部试验文档与资料，保证试验文件的妥当保管和归档，药品发放回收和销毁； 3 检查并报告试验进度和质量、病例报告表填写稽查、试验用药品使用、药品不良反响等各方面状况，发觉问题、分析问题、提出解决方案并实施； 4 对试验讨论过程中的不良大事和严峻不良大事进展跟踪，保障受试者权益和公司利益； 5 定期归纳并提交监查报告，填写相关报告及试验记录，确保数据真实精确、完整无误； 6 协调各讨论中心、数据治理人员之间的

2、沟通，培育并保持良好的关系； 7 完成上级交办的其它工作。 职位要求： 1、 临床医学或医药学相关专业，本科及以上学历； 2、 一年以上CRA工作阅历，能够独立进展中心治理； 3、 熟识药品注册治理方法、药品临床试验及GCP等相关法规； 4、 有良好的人际关系和良好的沟通及语言表达力量； 5、 能够适应常常出差； 工作地点：浦东张江哈雷路 岗位要求： 学历要求：本科 语言要求：不限年龄要求：不限工作年限：1年阅历 Edit 篇2:临床监察员-CRA-全国岗位职责描述岗位要求 职位描述： CRA 临床监察 Clinical Research Associate (CRA) - Covance C

3、hina Are you a Clinical Research Associate who wants to work with one of leading global CROs in the industry? Covance is seeking CRAs with at least 1 year clinical monitoring experience NATIONWIDE, and has a variety of CRA needs in Phase II-IV and Phase I (Early Clinical Development) in multiple the

4、rapeutic areas such as oncology, cardiovascular, diabetes mellitus, endocrinology, etc. Whether youre ready to make a move or just interested in learning more, apply TODAY and lets talk together! Covance China is committed to providing a clinical research career with purpose in a culture that values

5、 achievement. By joining our Clinical Trial Operations Team, you will work in a collaborative environment with the flexibility to pursue different clinical trials involving various compounds - giving you an excellent overview of best practices across the industry.Experience the global reach and ther

6、apeutic record of success from one of the few truly global drug development companies positioned to provide comprehensive clinical support from First-in-Human studies. Responsibilities/Duties: Clinical Research Associate performs site management, site administration and site monitoring responsibilit

7、y for clinical studies according to Covance Standard Operating Procedures, ICH Guidelines and GCP, including pre-study qualification and initiation visits, routine monitoring, close-out of clinical sites, and maintenance of study files. Responsibilities and duties include, but are not limited to the

8、 following: -Take charge of all aspects of Site Management as prescribed in the project plans. -Recruit potential investigators, prepare EC submissions, notify regulatory authorities, translate study-related documentation, and organize meetings and other tasks as instructed by supervisor. -Negotiate

9、 study budgets with potential investigators and collaborate with the Covance legal department with statements of agreements as assigned. -Complete Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs. -Independently perform CRF review; query generati

10、on and resolution against established data review guidelines on Covance or client data management systems as assigned by management. -Assist with training, mentoring, and development of new employees, e.g. co-monitoring. -Perform other duties as assigned by management. Education/Qualifications: -Uni

11、versity/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology). Experience: In lieu of the above requirement, candidates with three or more years of r

12、elevant clinical research experience in pharmaceutical or CRO industries will be considered. -Ability to monitor study sites independently according to protocol monitoring guidelines, S.O.P.s, GCP and ICH Guidelines. -Have a full understanding of the Serious Adverse Event (SAE) reporting, process pr

13、oduction of reports, narratives and follow up of SAEs. -CRA II positions require 2+ years of clinical research monitoring experience -Senior CRA positions require 4+ years of clinical research monitoring experience.Alternatively candidates with 4+ years supervisory experience in a health care settin

14、g and 3+ years clinical research experience in the pharmaceutical or CRO industries (including monitoring) may also be considered. Preferred: One or more additional years of experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred. More years of experience preferred if apply senior level CRA positions.