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臨床監(jiān)查員CRAII

1.4-1.5萬(wàn)
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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.)
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工作地點(diǎn)

濟(jì)南槐蔭區(qū)山東第一醫(yī)科大學(xué)附屬腫瘤醫(yī)院遠(yuǎn)程辦公

職位發(fā)布者

顧意蓉/高級(jí)人力資源專員

三日內(nèi)活躍
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），專注于為全球客戶提供覆蓋藥物全生命周期的臨床研究解決方案。聚焦腫瘤與自身免疫性疾病等核心領(lǐng)域，以專業(yè)深度驅(qū)動(dòng)臨床策略落地，助力差異化產(chǎn)品快速推進(jìn)。服務(wù)覆蓋I至IV期臨床，結(jié)合專家團(tuán)隊(duì)與智能管理平臺(tái)，助力創(chuàng)新療法高效上市，為全球患者帶來(lái)更佳治療選擇。
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