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更新于 9月9日

臨床監(jiān)查員 I(外派外資藥廠)

1-1.2萬(wàn)
  • 廣州越秀區(qū)
  • 1-3年
  • 本科
  • 全職
  • 招2人

職位描述

藥品臨床監(jiān)查疫苗罕見(jiàn)病
職責(zé)要求:
  • Drive study performance at the sites. Perform
    site monitoring and other onsite visit activities according to monitoring
    plan and in compliance with procedural documents. Provide the required
    monitoring visit reports within required timelines. Proactively identify
    study-related issues and escalates to Local Study Teams as appropriate.
  • Contribute to the selection of potential sites
    and investigators. Train, support and advise Investigators and site staff
    in study related matters.
  • Obtain and maintain essential documentation in
    compliance with ICH-GCP, Procedural Documents and local regulations.
    Manage study supplies (ISF, CRF, etc), drug supplies and drug
    accountability at study sites.
  • Perform source data verification according to SDV
    plan. Ensure data query resolution. Work with data management to ensure
    quality of the study data.
  • Ensure accurate and timely reporting of Serious
    Adverse Events.
  • Share relevant information on patient recruitment
    and study site progress within local Study Team. Update VCV and other
    systems with data from centres as per required timelines.
  • Prepare for activities associated with audits and regulatory
    inspections in liaison with local Study Team Lead and QA.
任職資格:
· Bachelor degree in biological science or healthcare-related
field., or equivalent
· Less than 2-year experience as a clinical monitor, performed
all tasks for a CRA position or joined CRA trainee program or equivalence.
· Understanding of the clinical dataflow.
· Good knowledge of the clinical study and drug development processes,
GCP/ICH guidelines and relevant local regulations.
· Good computer skills in Microsoft and other
software.
· Fluent in both oral and written English.
· Proficient written and verbal communication skills, collaboration and
interpersonal skills.

工作地點(diǎn)

廣州越秀區(qū)江灣商業(yè)中心

職位發(fā)布者

董雅喬/招聘經(jīng)理

立即溝通
公司Logo上海康德弘翼醫(yī)學(xué)臨床研究有限公司
康德弘翼(WuXi Clinical),是藥明康德(WuXi AppTec)的一家全資子公司。始終致力為全球客戶提供全方位的臨床研究服務(wù),包括藥品、生物制品、醫(yī)療器械、體外診斷試劑等醫(yī)藥產(chǎn)品,涵蓋BE(Bioequivalence)/ I期至IV期的臨床試驗(yàn)。通過(guò)嚴(yán)格的質(zhì)量控制體系和專業(yè)團(tuán)隊(duì)的豐富經(jīng)驗(yàn),幫助創(chuàng)新性,突破性醫(yī)藥產(chǎn)品盡快上市和造福患者??档潞胍砹⒆阒袊?guó),面向世界,以上??偛繛橹行模椛淙蛑扑幑?、生物技術(shù)公司以及醫(yī)療器械公司。目前,公司實(shí)行全球聯(lián)合運(yùn)營(yíng),人員規(guī)模達(dá)850+人,運(yùn)營(yíng)能力覆蓋中國(guó)、美國(guó)及澳大利亞等,并在上海、北京、廣州、武漢、成都、長(zhǎng)沙、西安、沈陽(yáng)、中國(guó)臺(tái)北、美國(guó)奧斯汀、美國(guó)圣地亞哥和澳大利亞悉尼等地均設(shè)有辦公室。公司團(tuán)隊(duì)與各研究中心建立了良好的合作關(guān)系,始終保持著緊密的業(yè)務(wù)交流,保證了項(xiàng)目能高效、高質(zhì)地完成。隨著業(yè)務(wù)能力和業(yè)務(wù)范圍的不斷拓展,康德弘翼進(jìn)一步完善和增強(qiáng)了全球一體化研發(fā)服務(wù)平臺(tái)的綜合實(shí)力,助力全球創(chuàng)新合作伙伴更好、更快地開(kāi)發(fā)醫(yī)藥產(chǎn)品。
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