Main tasks:
Applies knowledge of ICON’s policies and procedures
Demonstrates excellent written and oral communication
Demonstrates excellent knowledge of ICH/GCP
Displays ability to manage investigative sites to facilitate trial deliverables
Demonstrates ability to escalate issues appropriately
Conducts monitoring to confirm subject safety and data ntegrity
Describes and demonstrates the principals of IP accountability
Identifies scientific misconduct at the site level
Demonstrates working knowledge of Microsoft Office applications, Clinical Trial Management Systems, IVRS/IWRS and Electronic Data Capture platforms
Mentors CRAs new to the position or company
Serves as an observation visit leader
Conducts monitoring evaluation visits
Assists team lead in the development of trial tools or documents
Requirements:
· Read, write and speak fluent English; fluent in host country language required.
· 1+ years of clinical monitoring experience required
· Knowledge of ICH and local regulatory authority regulations regarding drug
· Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience required
· Clinical research experience
· Knowledge of ICH and local regulatory authority regulations regarding drug
· An advanced degree (e.g., M.S., M.B.A., PharmD, etc)
· Experience in monitoring all trial components (PSSV to COV)
· Experience in coaching/mentoring other CRAs
广州 - 越秀
北京东方百泰生物科技股份有限公司广州 - 白云
春天医药广州 - 海珠
瀚芯医疗科技(深圳)有限公司广州 - 越秀
润东医药广州 - 黄埔
广州汇智成功药物研究有限公司广州 - 黄埔
上海嘉坦医药科技有限公司