職位描述
CTACRA藥品臨床研究生物醫(yī)學研究心血管研究腫瘤研究神經(jīng)科研究新藥生物藥Ⅱ期Ⅲ期
The role:
? Become familiar with ICON’s SOPs/WPs, ICH GCP guidelines, appropriate regulations, ICON systems and the principles of and assist with investigator recruitment
? Maintain timelines and ensure accuracy and completeness of data entered into ICON systems
? Serve as the primary in-house contact for sites and investigators participating in studies
? Conduct and completes remote site management activities, with support as needed, according to applicable SOPS and the Study Monitoring Plan.
? To contact Clinical sites for specific requests (e.g. enrolment updates, missing documentation, data entry timeliness, data query follow-up, CDA finding follow-up, and action Item resolution or other sponsor specific CRA tasks.
? Take responsibility for project tasks and sees these tasks through to successful completion, with support.
? Maintain a professional interpersonal relationship with study team, sites, and Sponsors
? Participate in QA Audits as needed.
? Regularly attend and gives to project specific and departmental meetings
? Ability and willingness to travel as needed (drive and fly)
? Maintain Sponsor and patient confidentiality
? Other duties as assigned
You will need:
? Minimum Bachelor's degree in a life science
? At least 12 months of a CTA/Clinical Trial Assistant or similar role experience within the clinical/pharmaceutical industry
? Understanding of ICH GCP Compliance
? Excellent communication and organizational skills
? A phenomenal teammate
? Become familiar with ICON’s SOPs/WPs, ICH GCP guidelines, appropriate regulations, ICON systems and the principles of and assist with investigator recruitment
? Maintain timelines and ensure accuracy and completeness of data entered into ICON systems
? Serve as the primary in-house contact for sites and investigators participating in studies
? Conduct and completes remote site management activities, with support as needed, according to applicable SOPS and the Study Monitoring Plan.
? To contact Clinical sites for specific requests (e.g. enrolment updates, missing documentation, data entry timeliness, data query follow-up, CDA finding follow-up, and action Item resolution or other sponsor specific CRA tasks.
? Take responsibility for project tasks and sees these tasks through to successful completion, with support.
? Maintain a professional interpersonal relationship with study team, sites, and Sponsors
? Participate in QA Audits as needed.
? Regularly attend and gives to project specific and departmental meetings
? Ability and willingness to travel as needed (drive and fly)
? Maintain Sponsor and patient confidentiality
? Other duties as assigned
You will need:
? Minimum Bachelor's degree in a life science
? At least 12 months of a CTA/Clinical Trial Assistant or similar role experience within the clinical/pharmaceutical industry
? Understanding of ICH GCP Compliance
? Excellent communication and organizational skills
? A phenomenal teammate
工作地點
上海市黃浦區(qū)西藏中路168號(人民廣場地鐵站1號口步行200米)12樓
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職位發(fā)布者
王女士/人事經(jīng)理
今日活躍立即溝通
愛恩康臨床醫(yī)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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