職位描述
新藥生物藥化學(xué)藥Ⅰ期Ⅱ期Ⅲ期GCP認(rèn)證GCP證書CFDA認(rèn)證
As a Clinical Research Associate at ICON, you’ll work within a large-scale, fast-paced environment alongside a close-knit team of highly qualified CRAs to identify, select, initiate and close-out investigational sites for clinical studies in phases II – IV, ensuring adherence to applicable regulations and principles of ICH-GCP.
The role:
? Independent, proactive work to set up and monitor studies, complete reports and maintain documentation
? Submitting protocol, consent documents for ethics/IRB approval, as well as preparing regulatory submissions
? Balancing sponsor generated queries
? Taking responsibility for study cost efficiency
? Preparation and review of study documentation and feasibility studies for new proposals
? Potential to assist in training and mentoring fellow CRAs
You will need:
? 12 months+ of monitoring experience in phase I-III trials as a CRA
? College degree in medicine, science, or equivalent
? Previous monitoring experience in medium-sized studies, including study start-up and close-out
? Knowledge of ICH-GCP guidelines and ability to review and evaluate medical data
? Excellent written and verbal communication
? Ability to work to tight deadlines
? Availability to travel least 60% of the time (international and domestic -fly and drive) and should possess a valid driving license
The role:
? Independent, proactive work to set up and monitor studies, complete reports and maintain documentation
? Submitting protocol, consent documents for ethics/IRB approval, as well as preparing regulatory submissions
? Balancing sponsor generated queries
? Taking responsibility for study cost efficiency
? Preparation and review of study documentation and feasibility studies for new proposals
? Potential to assist in training and mentoring fellow CRAs
You will need:
? 12 months+ of monitoring experience in phase I-III trials as a CRA
? College degree in medicine, science, or equivalent
? Previous monitoring experience in medium-sized studies, including study start-up and close-out
? Knowledge of ICH-GCP guidelines and ability to review and evaluate medical data
? Excellent written and verbal communication
? Ability to work to tight deadlines
? Availability to travel least 60% of the time (international and domestic -fly and drive) and should possess a valid driving license
工作地點(diǎn)
北京市大興區(qū)宏達(dá)北路8號(hào)院(萬源街地鐵站B1南口步行100米)
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愛恩康臨床醫(yī)學(xué)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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