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Graduate Content Specialist

The Programme

Clinipace Worldwide,一个基于科技的全球性全方位服务的数字化合同研究组织(dCRO)。我们开创性的开发了依靠技术创新的CRO服务模式,以满足风险投资支持的,中型的战略性制药,生物技术公司以及医疗器械公司的研发需求。 借助于我们专有的TEMPO?电子化临床试验平台,我们的专家团队用他们丰富的治疗领域知识和见解来帮助生命科学公司制定和执行注册策略,临床开发和上市后研究,以确保药物和医疗器械开发计划的成功。 Clinipace Worldwide的唯一目标就是通过开拓创新的技术继续坚定不移地致力于客户的成功,以最具性价比的全球性解决方案服务客户,提供高透明度,灵活和高质量的服务。 我们已经开展了超过1500个全球性的临床研究,完成了超过300个注册和开发策略制定项目。治疗领域涵盖如心血管和代谢,中枢神经系统,皮肤,消化,免疫,感染,肾脏,肿瘤,呼吸,风湿和疫苗(和其他细胞和组织疗法)。 Clinipace Worldwide刚刚庆祝了他们的10週年。如今,Clinipace Worldwide其总部设在美国北卡罗莱纳州的Research Triangle Park,为横跨4大洲的27个国家提供服务。 因为对更高的数据准确度,经济高效的解决方案和更低的研发成本的需求在不断的增加,Clinipace Worldwide还在持续的在全球扩张。

Responsibilities

  • Coordinates the collection and entry of project tracking including but not limited to the following essential documents, patient data, site visit dates, protocol deviations, and trip reports into tracking systems
  • Communicates project status to the project team as appropriate
  • Assists in the retrieval and resolution of issues with transmittals
  • Scans and copies project documentation inclusive of, but not limited to, essential documents, CSAs, CRFs, and DCFs
  • Copies, collates and produces study binders
  • Reviews deliverable to ensure accuracy of content and materials copied
  • Supports the project team in preparation of documentation for Regulatory and Ethical Submissions
  • Organizes study documents and materials in compliance with Project and/or Sponsor SOPs regarding regulatory documentation as appropriate
  • Archives study documentation and returns TMF to sponsor, as directed
  • Reports all document collection and tracking issues to SMS Team Lead and/or project team on a regular basis
  • Establishes and maintains QC of the Trial Master File in accordance with project, organisational and regulatory requirements

Required Skills and Abilities

  • College graduate, preferably with a healthcare or life science degree
  • Secondary school (GCSE) completion and / or high school diploma considered with prior work experience
  • More than 1 year experience of clinical trial assistant is preferred
  • English: Good at speaking, writing
  • Job type:Graduate jobs
  • Citizenships:

  • Locations:

    Shanghai (China)

  • Closing Date:22nd Aug 2018, 6:00 pm

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