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臨床監(jiān)查員CRAII

1.4萬-1.8萬
  • 溫州鹿城區(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

溫州醫(yī)科大學(xué)附屬眼視光醫(yī)院homebase

職位發(fā)布者

顧意蓉/高級人力資源專員

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公司Logo上?？档潞胍磲t(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。通過嚴格的質(zhì)量控制體系和專業(yè)團隊的豐富經(jīng)驗，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嫦蚴澜?，以上?？偛繛橹行?，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，公司實行全球聯(lián)合運營，人員規(guī)模達850+人，運營能力覆蓋中國、美國及澳大利亞等，并在上海、北京、廣州、武漢、成都、長沙、西安、沈陽、中國臺北、美國奧斯汀、美國圣地亞哥和澳大利亞悉尼等地均設(shè)有辦公室。公司團隊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，康德弘翼進一步完善和增強了全球一體化研發(fā)服務(wù)平臺的綜合實力，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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