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更新于 5月14日

SSU 臨床啟動(dòng)專員

1-1.8萬·13薪
  • 北京朝陽區(qū)
  • 1-3年
  • 本科
  • 全職
  • 招1人

職位描述

CTACRC醫(yī)藥制造
職責(zé)描述: 1.根據(jù)試驗(yàn)方案、SOP、GCP 和合同規(guī)定的工作范圍,負(fù)責(zé)研究中心 GCP/EC 文件準(zhǔn)備、遞交溝通工 作,并協(xié)助取得倫理批件; 2.負(fù)責(zé)研究中心臨床試驗(yàn)協(xié)議的擬定、談判與簽署以及經(jīng)費(fèi)預(yù)算表制作等工作; 3.可同時(shí)負(fù)責(zé)多個(gè)項(xiàng)目、不同治療領(lǐng)域內(nèi)的研究中心啟動(dòng)工作; 4.及時(shí)向項(xiàng)目組反饋與研究中心溝通意見,并協(xié)助解決項(xiàng)目啟動(dòng)階段發(fā)生的各種問題; 5.定期更新和維護(hù)公司內(nèi)部系統(tǒng)數(shù)據(jù)庫以及項(xiàng)目 tracker 信息; 6.根據(jù)申辦方要求、臨床試驗(yàn)方案及研究中心基本規(guī)定,合理制定項(xiàng)目計(jì)劃、評(píng)估項(xiàng)目完成時(shí)間表; 7.負(fù)責(zé)協(xié)調(diào)研究中心啟動(dòng)所需必要文件的收集、審閱和批準(zhǔn)等工作; 8.在規(guī)定的項(xiàng)目時(shí)間限內(nèi),管理記錄并實(shí)時(shí)跟蹤文件遞交進(jìn)度、倫理審評(píng)意見、合同談判流程等; 9.定期向項(xiàng)目組匯報(bào)所負(fù)責(zé)研究中心的研究進(jìn)度并制定后續(xù)工作計(jì)劃; 10.與其他職能部門共同合作,或需直接與申辦方溝通相關(guān)工作。 任職要求: 1.本科及以上學(xué)歷,醫(yī)藥相關(guān)專業(yè); 2. 了解相關(guān)臨床研究知識(shí)和適用的法規(guī)要求; 3. 1 年以上臨床經(jīng)驗(yàn),有 SSU/CRA/CRC 經(jīng)驗(yàn)者優(yōu)先考慮; 4.良好的學(xué)習(xí)能力和溝通能力,有效的時(shí)間管理和協(xié)調(diào)組織能力; 5. 英語讀寫熟練,可進(jìn)行基本對(duì)話,通過 CET-6 者優(yōu)先考慮

工作地點(diǎn)

朝陽區(qū)北京僑福芳草地購物中心

職位發(fā)布者

鐘奕姣/HR

三日內(nèi)活躍
立即溝通
公司Logo愛恩康臨床醫(yī)學(xué)研究(北京)有限公司
At ICON we believe that our people are the most important asset. It is they who have helped to make ICON the success it is. Their commitment to clients, quality and delivery has earned ICON its enviable reputation. About DOCS: DOCS- ICON Resourcing Solutions is a division of ICON plc that provides global staffing solutions to Pharmaceutical, Biotechnology, Medical Device companies and CROs in over 39 countries. We can recruit in virtually any location having access to offices in over 25 countries. This truly makes DOCS a company with global reach and personal focus. ICON has been in APAC since 1996 and the DOCS division of ICON is now expanding in the APAC region. Our Services: We are a specialist recruitment division focusing in Clinical Research, Medical Affairs, Regulatory Affairs, Drug Safety, Health Economics, Data Management& Statistics, Quality Assurance etc. Our full-spectrum resourcing solutions extend from contingent staffing, to functional resourcing, large-scale FSP and executive search. In addition, DOCS has developed a tailored training division‘CRAcademy’ to provide Traineeships and Training. We can recruit in virtually any location having access to offices in over 25 countries. This truly makes DOCS a company with global reach and personal focus. Our History: DOCS was formed in The Netherlands in 1997 and grew to become the premier resourcing provider to the European pharmaceutical industry. The company was acquired by ICON plc in 2007 and was merged with ICON’s existing resourcing division, ICON Contracting Solutions. The merged company is now known as DOCS, and offers clients over 15 years of experience in the provision of global resourcing solutions. For more information, please visit www.docsglobal.com& www.iconplc.com.
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