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            400-885-9898
            更新于 5月9日
            智聯APPAPP
            舉報
            臨床監查員CRAII
            1.4-1.8萬
            • 溫州鹿城區
            • 1-3年
            • 本科
            • 全職
            • 招999人
            職位描述
            Ⅱ期Ⅲ期Ⅰ期藥品臨床監查GCP認證
              崗位職責:
              ?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
            鹿城區溫州醫科大學附屬眼視光醫院homebase
             
             
            職位發布者
            顧意蓉/高級人力資源專員
            三日內活躍
            立即溝通 
            公司Logo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？档潞胍砹⒆阒袊?，面向世界，以上?？偛繛橹行模椛淙蛑扑幑?、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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