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2年经验 -
本科 -
招1人 -
11-09 发布
职位描述
职位描述： Research local requirements for documentation of IRB/EC submission approval, and subsequent follow-up documentationLiaise with study sites regarding essential document collection and, as required by country, site contract/budget negotiationsAssist with IRB/ EC submissions (EC/IRB) as requiredArrange / review translations of regulatory documents as requiredCustomize country/site specific Patient Information sheet and Informed Consent FormsReview study documents as required, e.g., patient directed materialsProvide regular local status updates to SSU project Lead; update appropriate study – tracking tools with local essential document and ethics committee status, when requiredAssist Feasibility Group with conduction of feasibility studies as requiredAssist project teams with site selection activities as requiredEnsure all relevant documents are submitted to Trail Master File (TMF) as per company SOP/Sponsor requirementsComplete review of essential documents following Essential Document Checklist QCWhere applicable, support the Grants and Contracts group in the negotiation of contracts and budgetsProvide updates of local processes and requirements to Regulatory Intelligence PortalProvide support, mentoring and training to junior staffJob Requirement:Bachelor’s Degree in life science, pharmacy, or nursing preferred 2.5 years clinical research/monitoring experience including 2 years study start up experience Ability to lead and follow task specific procedures, be attentive to detail and place importance on accuracy of information Ability to effectively interact with project team(s) and effectively communicate in English and the local language of the country where located Ability to work independently in a fast paced environmentCandidates who are interested, please submit your English CV to: lingfeng.yang@inventivhealth.com 职能类别： 临床研究员
联系方式
国贸
公司信息
InVentiv Health通过分布在全球70多个国家的14000名员工，为医药、医疗器械和生物工程客户提供临床研发、销售及商务咨询服务，inVentiv Health的目标是通过自身的专业服务将客户的商业理念真正地转化为现实，帮助客户提升业绩，现在inVentiv Health服务于约550家客户的850个品牌。 2011年12月，inVentiv Health在中国设立盈帆达医药咨询（上海）有限公司，正式在中国区域为医药行业客户提供服务。 inVentiv Health Clinical, formerly PharmaNet/i3, is a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies. With 7,000 employees in more than 36 countries, inVentiv Health Clinical offers therapeutically specialized capabilities for all phases of clinical development, bio-analytical services, and strategic resourcing from a single clinical professional to an entire functional team.
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