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 知名CRO公司诚聘Senior CRA |
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flying-eagle
头衔: 海归中士
加入时间: 2011/04/21
文章: 7
来自: 上海
海归分: 964
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作者：flying-eagle 在 生化制药 发贴, 来自【海归网】 http://www.haiguinet.com
Responsibility:
To responsible for all phases clinical trial management of project (regardless of the treatment area)，to be project manager and key client / key project / key center(PI) monitoring ,to make sure all trials follow protocol/ Rundo-Cronova’s SOP/sponsor’s SOP, ICH GCP/cGCP and related regulations.
To conduct the exhaustive quality control and management of the responsible clinical trails. To initiate, execute, monitor, and close the whole trial .To communication with other department staff timely.
To communicate with sponsor and your leader timely, to choose center and investigator, to perform and control budget.
To submit progress report and Newsletter to sponsor and investigator timely.
To coordinate preparation work before audit or inspect.
To deploy all project related documents, investigational products and to confirm with sponsor the time points of material distribution and financial affairs.
To transfer information in time and to keep good relationship with clients and investigators.
To perform project related training to CRA, CTA and to manage project.
To check and sign monitoring report and other TMF documents, to check and approve center agreements, to support and advice quotation and related contract documents.
To support CRM, CRD and business department seek new project cooperation and Business Development.
With all the duties of CRA and ability to deal with a sudden incident contingency，also be able to be CRA and project manager's main emergency back-up candidates.
To report to related regulatory requirements following to ICH-GCP/GCP in time.
To assist investigator and related department to finish final report, signature and stamp.
New staff candidates interview support with CRM for the position of CRC, CTA and CRA.
To built and perfect medical expert resources system.
Qualification:
Above 3 years monitoring experience in CRO or Pharmaceutical Companies and at least 2 years project management experience.
At least one global multi-center clinical trial monitoring experience and many strict trials’ management experience.
作者：flying-eagle 在 生化制药 发贴, 来自【海归网】 http://www.haiguinet.com
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 知名CRO公司诚聘Senior CRA -- flying-eagle - (2136 Byte) 2011-4-21 周四, 11:52 (1981 reads)
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