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臨床監(jiān)查員CRAII

1.4萬(wàn)-1.8萬(wàn)
  • 北京朝陽(yáng)區(qū)
  • 1-3年
  • 本科
  • 全職
  • 招999人

職位描述

Ⅱ期Ⅲ期Ⅰ期藥品臨床監(jiān)查GCP認(rèn)證
崗位職責(zé):
?Implements and monitors local clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH‐GCP guidelines
?Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites
?Reviews and verifies accuracy of clinical trial data collected, either onsite or remotely
?Provides regular site status information to team members, trial management, and updates trial management tool.
?Completes monitoring activity documents as required by Company or Sponsor SOPs or other contractual obligations
?Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues
?Escalates site and trial related issues per Company SOPs, until identified issues are resolved or closed
?Performs essential document site file reconciliation
?Performs source document verification and query resolution
?Assesses IP accountability, dispensation, and compliance at the investigative sites
?Verifies Serious Adverse Event (SAE) reporting according to trial specifications and relevant local and ICH GCP guidelines
?Communicates with investigative sites
?Updates applicable tracking systems
?Ensures all required training is completed and documented
?Be assigned logistical support tasks by CTM for Investigator Meetings
任職要求:
1. About 2 years of local trial experience; exposure to MNC and global or Local Phase I -IV trials Clinical research experience
2. Knowledge of ICH and local regulatory authority regulations regarding drug
3. An advanced degree (e.g., M.S., M.B.A., Phar.D., etc.)

工作地點(diǎn)

兆泰國(guó)際中心C座8層

職位發(fā)布者

顧意蓉/高級(jí)人力資源專員

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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。康德弘翼立足中國(guó)，面向世界，以上海總部為中心，輻射全球制藥公司、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、更快地開發(fā)醫(yī)藥產(chǎn)品。
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