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无工作经验
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招若干人
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01-08 发布
职位描述
Responsibilities:Independent and proactive coordination of all the necessary activities required to set up and monitor a study , including but not limited to the following :Identify investigators. Help when requested , in preparation of regulatory submissions .Design of patient information sheets and consent forms .Ensure timely submission of protocol/consent documents for ethics/IRB approval.Pre study/placement and initiation visits.Conduct regular monitoring visits in accordance with the ICON site monitoring SOP/sponsor site monitoring SOP, as appropriate Maintain all files and documentation pertaining to studies .Motivate investigators in order to achieve recruitment targets.Complete accurate study status reports.Ensure the correct storage of drugs and the diligent account of all drugs in accordance with SOPs.Keep the Project Manager regularly informed.Process case record forms to the required quality standards and timelines.Deal with sponsor generated queries in a timely manner.Ensure the satisfactory close-out of investigator sites.Participate, if requested, in the preparation of and review of study documentation , e.g. draft protocols, draft CRFs, monitoring guidelines and elements of final report.Participate in feasibility studies for new proposals as required.Ensure correct archiving of files on completion of a study.Maintain patient and sponsor confidentiality .Assume additional responsibilities as directed by the Project Manager. - lnvestigational Products (IPs) stored and managed by the site.Requirements:Tertiary qualification in Science or related fieldMUST have at least 2 years monitoring experienceStrong communication and relationship building skillsGood multitasking, time management and prioritization skillsProactive approach and ability to work autonomously as well as part of a teamDemonstrate professionalism, commitment and passionPlease feel free to reach out to ashley.li@iconplc.com for more details or referrals. 职能类别: 临床研究员
联系方式
广州市
公司信息
ICON Clinical Research-- a top global CRO company. For more details, please kindly see our website - http://www.iconplc.com/
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