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更新于 4月16日

臨床監察員CRA II

1.3-1.6萬
  • 上海黃浦區
  • 1-3年
  • 本科
  • 全職
  • 招1人

职位描述

藥品臨床監查GCP認證Ⅰ期Ⅱ期Ⅲ期
工作職責: 1. The Clinical Research Associate (CRA) will monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH‐GCP, and all applicable, Regulatory requirements. 2. 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 3. 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 4. Reviews and verifies accuracy of clinical trial data collected, either onsite or remotely 5. Provides regular site status information to team members, trial management, and updates trial management tools 6. Completes monitoring activity documents as required by Company or Sponsor SOPs or other contractual obligations 7. Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues 8. Escalates site and trial related issues per Company SOPs, until identified issues are resolved or closed 9. Performs essential document site file reconciliation 10. Performs source document verification and query resolution 11. Assesses IP accountability, dispensation, and compliance at the investigative sites 12. Verifies Serious Adverse Event (SAE) reporting according to trial specifications and relevant local and ICH GCP guidelines 13. Communicates with investigative sites 14. Updates applicable tracking systems 15. Ensures all required training is completed and documented 16. Be assigned logistical support tasks by CTM for Investigator Meetings 任職資格: 1. 2 to 4 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.)
職位福利:五險一金、績效獎金、彈性工作、節日福利、周末雙休

工作地点

上海黃浦區Soho復興廣場
以担保或任何理由索要财物,扣押证照,均涉嫌违法。一经发现,

职位发布者

董雅喬/人事經理

剛剛活躍
立即沟通
上??档潞胍磲t學臨床研究有限公司
??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,包括藥品、生物制品、醫療器械、體外診斷試劑等醫藥產品,涵蓋BE(Bioequivalence)/ I期至IV期的臨床試驗。通過嚴格的質量控制體系和專業團隊的豐富經驗,幫助創新性,突破性醫藥產品盡快上市和造?;颊摺?康德弘翼立足中國,面向世界,以上??偛繛橹行?,輻射全球制藥公司、生物技術公司以及醫療器械公司。目前,公司實行全球聯合運營,人員規模達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有辦公室。公司團隊與各研究中心建立了良好的合作關系,始終保持著緊密的業務交流,保證了項目能高效、高質地完成。隨著業務能力和業務范圍的不斷拓展,康德弘翼進一步完善和增強了全球一體化研發服務平臺的綜合實力,助力全球創新合作伙伴更好、更快地開發醫藥產品。
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