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            400-885-9898
            更新于 4月28日
            智聯APPAPP
            舉報
            臨床監查員 II（外派外資藥廠）
            1.3-1.6萬·14薪
            • 廣州越秀區
            • 1-3年
            • 本科
            • 全職
            • 招16人
            職位描述
            藥品臨床監查腫瘤
            職責要求：
 

               
 
            • Drive performance at the sites. Perform site
monitoring and other onsite visit activities according to monitoring plan
and in compliance with procedural documents . Provide the required
monitoring visit reports within required timelines. Proactively identify
study-related issues and escalates to Local Study Teams as appropriate. 
              •  
 
            • Contribute to the selection of potential
investigators. Train, support and advise Investigators and site staff in
study related matters. 
              •  
 
            • Obtain and maintain essential documentation in
compliance with ICH-GCP, Procedural Documents and local regulations.
Manage study supplies (ISF, CRF, etc), drug supplies and drug
accountability at study sites. 
              •  
 
            • Perform source data verification according to SDV
plan. Ensure data query resolution. Work with data management to ensure
quality of the study data. 
              •  
 
            • Ensure accurate and timely reporting of Serious
Adverse Events. 
              •  
 
            • Share relevant information on patient recruitment
and study site progress within local Study Team. Update VCV and other
systems with data from centres as per required timelines 
              •  
 
            • Prepare for activities associated with audits and regulatory
inspections in liaison with local Study Delivery Team Lead and QA. 
              •  

            
·      
任職資格：

               
 
            • Bachelor degree
in biological science or healthcare-related field, or equivalent 
              •  

            
·       Minimum 2-year
experience as CRA or other related fields. Experience as a clinical monitor,
performed all tasks for a CRA position.

               
 
            • Knowledge of the Monitoring Process, such as
understanding of the Study Drug Handling Process and the Data Management
Process, etc. 
              •  

            
·       Understanding of the clinical dataflow
·       Solid knowledge
of the clinical study and drug development processes, GCP/ICH guidelines and
relevant local regulations
·       Good computer skills in Microsoft and other
software.
·       Fluent in both oral and written English.

               
 
            • Proficient
written and verbal communication skills, collaboration and interpersonal
skills.
              •  

            工作地點
            廣州越秀區江灣商業中心
             
             
            職位發布者
            董雅喬/招聘經理
            剛剛活躍
            立即溝通 
            公司Logo上海康德弘翼醫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嫦蚴澜?，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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