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
廣州 - 越秀
潤(rùn)東醫(yī)藥廣州 - 越秀
天津樂(lè)果藍(lán)天管理咨詢有限公司廣州 - 黃埔
廣州匯智成功藥物研究有限公司廣州 - 海珠
沈陽(yáng)三生制藥有限責(zé)任公司廣州 - 海珠
瀚芯醫(yī)療科技(深圳)有限公司廣州 - 越秀
北京諾和德美醫(yī)藥技術(shù)有限公司