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无工作经验 -
招若干人 -
11-09 发布
职位描述
职位描述: About the Job:As a Clinical Research Associate, you will be responsible for making sure that the proper standard of protocol is being met at all terms of the clinical trial study, and you are to ensure that the scheduled methods are being executed in the manner in which they should.· Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned· Responsible for all aspects of site management as prescribed in the project plans· Recruitment of potential investigators, submissions preparation, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor· Negotiate study budgets with potential investigators and assist the Covance legal department with statements of agreements as assigned· Complete Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs· Independently perform Case Report Forms (CRF) review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by managementRequirements:· Minimum of four (4) years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits)· In lieu of the above requirements, candidates with > four (4) years supervisory experience in a health care setting and three (3) years clinical research experience in the pharmaceutical or CRO industries (including monitoring) may be considered· Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEsAbout Covance:Covance Clinical Development Services is based on an integrated clinical development services that is unique to Covance as we are one of the few truly global drug development companies positioned to provide comprehensive clinical support from First-in-Human studies through pivotal Phase III global clinical trialAt Covance, you'll discover your professional home to learn, grow and achieve. We offer careers with a purpose in an environment that values achievement, supports a balance between your personal and professional life, and allows you to make meaningful contributions to human healthcare.Why Covance?At Covance, you can make a difference by helping to deliver life-saving and life-enhancing medicines to people around the world. Our commitment to this mission has resulted in Covance’s impressive history of company stability and growth. We’ve achieved these results by fostering a work environment that encourages, develops and leverages our team’s capabilities. Covance’s ongoing success offers team members unsurpassed growth and career development opportunities. There’s no better time to join us! 职能类别: 生物工程/生物制药
联系方式
建国门外大街
公司信息
Why Covance? At Covance, you will join like-minded professionals who, together, build our reputation as one of the world's largest and most respected contract research organizations. In choosing Covance, you will be part of a dedicated team that makes a difference in helping to deliver life-saving and life-enhancing medicines to people around the world. We Offer Covance’s ongoing success offers team members unsurpassed growth and career development opportunities. At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career. There is no better time to join us!
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