Senior Clinical Research Associate I, SH招聘_科文斯医药研发（上海）有限公司最新招聘信息-猎才医药网

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职位描述： We are always looking for talented clinical research professionals for Senior Clinical Research Associate I, Shanghai 高级临床研究员 in Shanghai. If you are already working in the clinical trial industry in site monitoring and study site management, we want to talk to you about your career development.Covance is committed to providing a clinical research career with purpose in a culture that values achievement. By joining our Clinical Operations team, you will work in a collaborative environment with the flexibility to pursue different clinical trials involving various compounds – giving you an excellent overview of best practices across the industry. Experience the global reach and therapeutic record of success from 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 trials. Whether you’re ready to make a move or just interested in learning more, apply today and let’s talk!About the job:Clinical Research Associates manage all aspects of study site monitoring according to Covance SOP, GCP, and ICH guidelines, including pre-study qualification and initiation visits, routine monitoring, close-out of clinical sites, and maintenance of study files.Responsiblities:Assures the implementation of project plans as assigned.Function as leader for projects of limited scope as assigned.Assume line management responsibilities as assigned.Site administration and site monitoring responsibility for clinical studies according to Covance Standard Operating Procedures, ICH Guidelines and GCP.Site management responsibility for clinical studies according to Covance Standard Operating Procedures, ICH Guidelines and GCP.Registry management responsibility for clinical studies according to Covance Standard Operating Procedures, ICH Guidelines and GCP.Act in the project role of as Local Project Coordinator or Lead CRA as assigned.Responsibilities/Duties A. Duties and Responsibilities:Manage small projects under direction of a Project Manager/Director as assigned.Serve as lead monitor for a protocol or project and may assist in establishing monitoring plans as assigned.Review progress of projects and initiate appropriate actions to achieve target objectives.Report, write narratives and follow-up on serious adverse experiences.Participate in the development of protocols and Case Report Forms as assigned.Participate in writing clinical trial reports as assigned.Interact with internal work groups to evaluate needs, resources and timelines.Act as contact for clinical trial supplies and other suppliers (vendors) as assigned.Responsible for all aspects of site management as prescribed in the project plans.Responsible for all aspects of registry management as prescribed in the project plans.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.General On-Site Monitoring Responsibilitiesa) Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study.b) Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.c) Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review. Monitor data for missing or implausible data.d) Ensure the resources of the Sponsor and Covance are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Covance travel policy.e) Prepare accurate and timely trip reports.Undertake feasibility work when requested.Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor as assigned.Negotiate study budgets with potential investigators and assist the Covance legal department with statements of agreements as assigned.Complete process of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.Independently perform CRF review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by management.Assist with training, mentoring and development of new employees, e.g. co-monitoringCo-ordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned.Perform other duties as assigned by management.Education/QualificationsEducation/Qualifications:Required: University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology. In lieu of the above requirement, candidates with four (4) or more years of relevant clinical research experience in pharmaceutical or CRO industries will be considered. Fluent in local office language and in English, both written and verbal.Experience III. Experience:Required:? 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 > five (5) years supervisory experience in a health care setting and three (3) years clinical research experience in the pharmaceutical or CRO industries (including monitoring) will be considered.? In lieu of the above requirements, candidates with four (4) years of site management and/or registry administration experience will be considered.? Have a full understanding of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.? Excellent site monitoring skills.? Excellent study site management skills.? Excellent registry administration skills.? Ability to work with minimal supervision.? Good planning and organization skills.? Good computer skills with good working knowledge of a range of computer packages.? Excellent verbal and written communication skills.? Ability to train and supervise junior staff.? Ability to resolve project-related problems and prioritizes workload for self and team.? Ability to work within a project team.? Works efficiently and effectively in a matrix environment.Preferred:? One (1) or more year’s additional experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred.? Local project coordination and/or project management.? Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries.? Thorough understanding of the drug development process.Preferred:? Thorough knowledge of Covance S.O.P.s regarding site monitoring.About Covance Asia PacificCovance is one of the world’s largest and most comprehensive drug development services companies with more than 11,000 employees in 60 countries. Through its discovery, nonclinical, clinical and commercialization services, Covance has helped pharmaceutical and biotech companies develop one-third of all prescription medicines in the market today.Asia Pacific is a core element in Covance's ability to support the pharmaceutical industry in bringing the miracles of medicine to market sooner. We began operations in the Asia Pacific region in 1988 and today, we continue to grow and now have over 1000 employees in 13 countries across the region.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 welcome your application and believe this decision may be the most rewarding career move you will ever make! 职能类别：生物工程/生物制药

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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!

周边城市招聘：上海浙江安徽广东山东河北重庆北京江苏湖南

企业入驻日期： 2017-11-09

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