佛山 [切换城市] 佛山招聘

临床监查员(CRA)(J12769)

上海复星医药(集团)股份有限公司

  • 公司规模:10000人以上
  • 公司性质:民营公司
  • 公司行业:制药/生物工程

职位信息

  • 发布日期:2024-06-19
  • 工作经验:1年
  • 学历要求:本科
  • 职位月薪:1-1.3万·14薪
  • 职位类别:临床监查员(CRA)(J12769)

职位描述

工作职责:
1 Good knowledge of the study protocol, therapeutic fields and study relevant procedures.
2 Perform site monitoring visits (not limited to feasibility , selection, initiation, monitoring and close out visits) in compliance with Good Clinical Practice (GCP), ICH-GCP, Local Laws & Regulations, Fosun SOPs, Protocol, Site Monitoring Plan and associated documents.
3 Conduct protocol and study related training to responsible sites and establish regular communication line with site staff to make sure project management and issues resolution as scheduled
4 Communicates with site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance. Report quality issues to the responsible PM and/or line manager.
5 Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator’s Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
6 Create and maintain appropriate documentation (clear, comprehensive and accurate) regarding site management, monitoring visit & non-visit findings and action plans by submitting regular visit reports, generating follow-up letters, contact reports and other required study documentation in a timely manner.
7 Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
8 Independently perform eCRF review; query generation and resolution against established data review guidelines or data management systems as assigned by management.
9 Representation of CRAs during an audit or inspection when assigned
10 Assist the project manager to complete sample distribution, contract payment, summary report, etc.
11 Conduct and assist with administrative activities as a member of the project team.
任职资格:
Education 学历
Bachelor degree or above in medicine related major, master's degree is preferred
Experience 工作经验
At least 0.5 year of CRA experience, or 1-2 years CRC experience
Skills and Abilities 技能和能力
1 Good knowledge of Good Clinical Practice (GCP) and understanding of applicable regulatory requirements
2 Written and verbal communication skills including fluent in local languages and good command of English language.
3 Computer skill including proficiency in use of Microsoft word, Excel, etc.
4 Organizational and problem solving skills.
5 86 Effective time and financial management skills.

公司介绍

上海复星医药(集团)股份有限公司(简称“复星医药”,证券代码600196)成立于1994 年,1998 年8 月在上海证券交易所挂牌上市,是在中国医药行业处于领先地位的上市公司。

复星医药上市13年以来,净利润增长了13.55倍,年均复合增长率达到24.26%。销售收入、净资产、净利润、股票市值均名列中国医药上市公司前列。

复星医药重视多元文化的融合,重视团队的整体成就,尊重各个企业多元化的背景,强调通过内部坦诚相见,以开放的方式,建立彼此信任和相互支持,团结协作,发挥团队的组合作用。

复星医药注重创新研发,拥有***企业技术中心。在中国,复星医药已取得肝病、糖尿病、结核病、临床诊断产品等细分市场的领先地位。在全球市场,复星医药也已成为抗疟药物等领域的领先者。复星医药投资的国药控股于2009 在香港成功上市,成为中国最大、全球市值领先的医药流通类上市公司。目前,国药控股市场占有率已经超过10%,销售收入超出第二、三名总和。医药零售领域,复星医药旗下的药品零售品牌国大药房、复美大药房、金象大药房继续保持在各自区域市场的品牌领先和盈利能力领先,形成以上海、北京为中心,面向全国发展的医药零售格局。

面向未来,复星医药将继续以促进人类健康为使命,秉承“持续创新 共享健康”的理念,采取“内生式增长、外延式扩张和整合式发展”的战略发展手段,进一步加强在中国医药行业领先地位的同时,以创新战略为先导,面向国际、国内两个市场,打造具有国际竞争力的全球化医药健康企业。

联系方式

  • 公司地址:上海市宜山路1289号 (邮编:200233)