Clinical Research Associate/临床监查员 北京

月薪： 0.8-1万/月

该公司所有职位
  • 2年经验
  • 本科
  • 招若干人
  • 02-26 发布
  • 五险一金
  • 补充医疗保险
  • 通讯补贴
  • 年终奖金
  • 弹性工作
  • 定期体检
  • 专业培训

职位描述

Role PurposeThe Clinical Research Associate ensures that clinical trials are run in accordance with scientific and regulatory requirements (at site level) to optimise Institute objectives.Reporting RelationshipsThe Clinical Research Associate functionally reports to the Clinical Team Leader and reports to the Project Manager for project specific responsibilities. The position may be mentored and guided by Senior Clinical Research Associates. The position may also direct tasks of an allocated Clinical Trials Assistant. The Clinical Research Associate will be instrumental in developing effective working relationships with the program’s study site staff.Key accountabilitiesPre-study? Coordinate the identification, feasibility assessment and selection of investigators and sites to undertake the study? Prepare, plan, organize and conduct pre-study (site selection) visits and report on these visits to assist in site selection? Prepare for, plan, organize and conduct site initiation visits? Assist in the development of appropriate monitoring tools? Motivate and train investigators and ensure that the study site personnel have a good understanding of the protocol, the investigational product and the requirements of the study and that they can fulfil their obligations to conduct the study accurately and to deadlines.During Study? Monitor study by visit, email and telephone to the participating centers to ensure:? Verify quality, accuracy, completion, and timeliness of data.? Completely and efficiently resolve data and audits queries and issues.? Adhere to the study protocol and study procedures manual.? Adhere to ICH/GCP and other regulatory guidelines and requirements as relevant to this trial including reporting of adverse events/serious adverse events are reported? Complete all monitoring visit and progress reports accurately and within the predetermined timeframe.? Collect and review essential documents from study sites and ensure they are appropriately stored/managed in-house.? Assist participating centre research staff in the local management of the study where required.? Maintain study information using the clinical trial management system.Skills, Knowledge and Experience? Clinical medicine background, Bachelor degree is a ; Master degree will be preferred;? At least 2 years working experience in clinic; more than 1 year working experience in the clinical research operation is a plus.? Interest in research methodology;? Familiar with the organization of hospital;? Good organization skill;? Detail oriented;? Creative thinking;? Good interpersonal skill;? Work and travel independently; 职能类别： 生物工程/生物制药

联系方式

北京市海淀区知春路6号锦秋国际大厦B1802

公司信息

The George Institute China is a medical research institute, and a wholly-owned foreign enterprise, that was established as an affiliated partner with Peking University Health Science Centre in March 2007, whose registered name is Beijing George Medical Research Co. Ltd. The aim of the Institute is to promote high quality medical research through the conduct of randomised controlled trials and epidemiological studies with various government and non-government partners for the purpose of providing evidence-based approaches to improve the health of Chinese people.George Clinical is the clinical research delivery arm of the George Institute and manages phase I to phase IV clinical studies for both commercial and medical research organisations. George Clinical is recognized as a leading Clinical Research Organisation (CRO) bringing together medical and scientific expertise in the clinical trials area. George Clinical China is a wholly owned foreign enterprise and trades under the name George (Beijing) Clinical Research Co. Ltd.

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