職位描述
藥品臨床監查醫藥制造生物工程
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
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
工作地點
廣州天河區富力中心
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職位發布者
鐘奕姣/HR
昨日活躍立即溝通
愛恩康臨床醫學研究(北京)有限公司At ICON we believe that our people are the most important asset. It is they who have helped to make ICON the success it is. Their commitment to clients, quality and delivery has earned ICON its enviable reputation. About DOCS: DOCS- ICON Resourcing Solutions is a division of ICON plc that provides global staffing solutions to Pharmaceutical, Biotechnology, Medical Device companies and CROs in over 39 countries. We can recruit in virtually any location having access to offices in over 25 countries. This truly makes DOCS a company with global reach and personal focus. ICON has been in APAC since 1996 and the DOCS division of ICON is now expanding in the APAC region. Our Services: We are a specialist recruitment division focusing in Clinical Research, Medical Affairs, Regulatory Affairs, Drug Safety, Health Economics, Data Management& Statistics, Quality Assurance etc. Our full-spectrum resourcing solutions extend from contingent staffing, to functional resourcing, large-scale FSP and executive search. In addition, DOCS has developed a tailored training division‘CRAcademy’ to provide Traineeships and Training. We can recruit in virtually any location having access to offices in over 25 countries. This truly makes DOCS a company with global reach and personal focus. Our History: DOCS was formed in The Netherlands in 1997 and grew to become the premier resourcing provider to the European pharmaceutical industry. The company was acquired by ICON plc in 2007 and was merged with ICON’s existing resourcing division, ICON Contracting Solutions. The merged company is now known as DOCS, and offers clients over 15 years of experience in the provision of global resourcing solutions. For more information, please visit www.docsglobal.com& www.iconplc.com.
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