(Sr.)Clinical Research Associate(外派全球大药厂） 上海

月薪： 15-20万/年

该公司所有职位
  • 2年经验
  • 本科
  • 招20人
  • 11-09 发布

职位描述

职位描述： The responsibility of a Clinical Research Associate (CRA) is to perform the clinical monitoring aspectof designated projects in accordance with applicable SOP and regulations. Responsibilities includeperforming clinical on-site monitoring activities (drive patient recruitment, source data verification,drug accountability, data collection), collecting regulatory documentation (when required), performingqualification, initiation, monitoring and termination of i***estigational sites in accordance with ICHGCP guidelines.Key Accountabilities? Assume the ability to meet the requirements of a CRA I with a high degree of proficiency andautonomy? Take responsibility for specific tasks on projects, or acts as the main CRA contact on individualprojects? Train team members on selected tasks? Keep manager informed about work progress and any issues to avoid surprises. Requires someinteraction / supervision by Manager or assigned mentor.? Build relationships with i***estigators and site staff? Participate in I***estigator and other external or internal meetings as required? Arrange on-site visits and logistics (e.g. travel arrangements)? Perform on site visits in accordance with the monitoring plan? Conduct on-site study-specific training (if applicable)? Perform site facilities inspection? Monitor patient safety on-site (review for missing SAEs, AEs, ConMed) and address protocolviolations? Monitor and maintain ICH-GCP compliance? Responsible for the completeness and quality of the on-site files? Respond to site issue alerted from Clinical Monitoring Associate (i.e, non-responsive site,Protocol Deviations concerns, quality issues etc., items that require face to face interaction)? Collect SRP documents during QV and other visits as needed? Establish site recruitment plan in collaboration with site during Qualification Visit; follow-upand update at Initiation Visit and Monitoring Visit? Update all relevant tracking system on an ongoing basis? Collaborate with CMA on site issues/actions? Generate visit/contact report in accordance with monitoring plan? Code and scan Central File documents where applicable? Ship relevant wet-ink signature documents to the Assistant or back to the site? Escalate any issues that require immediate action to the CRA Coordinator/GRO Lead? Attend audits / Regulatory Inspection if requestedSkills? Strong computer and internet skills including knowledge of MS-Office products such as Excel,Word? Strong regulatory knowledge including GCP? Excellent interpersonal, verbal and written communication skills? Sound problem solving skills? Ability to successfully work in a (‘virtual’) team e***ironment? Sound presentation skills? Consultative skills? Client focused approach to work, ability to interact professionally within a client organization? Ability to prioritize multiple tasks and achieve project timelines? Able to take initiative and work independently.? Sense of urgency in completing assigned tasks? Able to travel a minimum of 65% on average? Holds a driving license where required? Effective time management in order to meet daily metrics or team objectives? Shows commitment to and performs consistently high quality workEducation? Educated to degree level (biological science, pharmacy or other health-related disciplinepreferred), equivalent nursing qualification or other equivalent experienceLanguage SkillsCompetent in written and oral EnglishNote, this CRA position, an outsourced role to our client, one of the largest global pharma (Fortune 500), you will be daily working in the client's office, we are offering the job growth title(up to Sr. CRA) basing on the working experience. 职能类别： 生物工程/生物制药 临床研究员

联系方式

上海市浦东新区银城中路488号太平金融大厦20层

公司信息

精鼎医药研究开发(上海)有限公司(PAREXEL International)，成立于1982年，是一家致力于药物临床试验研究的CRO (Contract Research Organization)集团公司。总部位于美国，分支机构遍布欧、美、亚、大洋四大洲，且于亚洲13个国家和地区设立了分支机构，致力深耕于当地。精鼎医药由一群具有丰富跨国性临床试验研发经验及专业知识的精英所组成，服务团队集合各种不同专业领域的人才。我们重视与客户的承诺，更重视人才的培育和养成，我们提供完整的教育训练、职涯规划、优于市场的薪资福利、良好工作环境，期许同仁与公司一同成长，迈向未来。 愿景（Vision）： 创造一个在亚太地区具有国际竞争力的最精良CRO团队。 发展使命（Mission）： 1．争取国际大药厂委托，执行符合国际水准的跨国性临床试验。 2．协助亚太生技及制药产业建立新药开发模式，以提升产品研发能力，幷促使产品国际化。 3．以提升临床试验品质为宗旨，拓展全球市场为目标，整合计算机及通讯科技，在国际上提供客户兼具成本效益及效率的临床试验数据处理中心。 4．建立一个以亚洲人种高发生率疾病的基因数据库，以提供国际性新药研发机构所须之基因信息，协助其缩短药物开发时程，幷提高研发成功率。 公司福利和人才培养计划： 保险类： 1. 社会保险(依照国家规定)及住房公积金； 2. 团体保险（包括寿险、意外暨医疗保险）； 3. 补充医疗保险； 制度类： 1. 学习发展计划 (Learning & Development): 针对个别员工之专业及兴趣，设计符合其个人之生涯规划； 2. 完整的教育训练：每年公司均针对所有员工，提供完整之教育训练； 3. 顺畅的升迁管道及可转调其它部门；如有职缺，亦可申请调至海外各子公司； 请 / 休假制度： 1. 服务第一年即享有14天年假, 后续年休假天数则依据服务年资及公司制度而定； 2. 一年可享12天不扣薪病假； 3. 员工旅游, 年度体检； 精鼎医药将以培养国际性的人才为目标，欢迎具有国际观之人才加入。 应聘方法： 1.    在线投递； 2.    请登录我们的公司网站直接投您的简历（https://jobs.parexel.com/search-jobs） 我们在收到您的简历之后，会尽快与您联系。 谢谢！

上海相关职位

当前位置： 首页> 精鼎医药研究开发（上海）有限公司> (Sr.)Clinical Research Associate(外派全球大药厂）

上海相关职位： 医学信息沟通专员-心血管团队 医学信息沟通专员-肿瘤靶向团队 辉瑞制药 销售实习生(医学信息沟通专员) 医学信息沟通专员-肿瘤化疗团队（上海） 医学信息沟通专员 - 社区医疗团队（scc） 项目协调员 Admin Assistant 药品招标部实习生 财务部实习生 Medical Affair Intern 医学部实习生(上海）

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

猎才二维码