Senior Clinical Research Associate Home-based 上海

月薪： 1-2万/月

该公司所有职位
  • 3-4年经验
  • 本科
  • 招2人
  • 11-09 发布
  • 五险一金
  • 补充医疗保险
  • 定期体检

职位描述

职位描述： Position Description:The Senior Clinical Research Associate (SCRA) is responsible for monitoring and managing the conduct of clinical projects according to ICH-GCP, Standard Operating Procedures (SOP) and applicable Study Specific Procedures (SSP) and local regulatory requirements. In addition to the responsibilities as a CRA, the SCRA provides mentoring and coaching for junior personnel, and supports department training programs as a trainer and/or a topic expert.Responsibilities:1.Contribute comments/input in the development of Protocol, Informed Consent Form (ICF), Case Report Forms (CRF) and other project related documents.2.Evaluate potential sites and provide recommendations for selection of qualified sites.3.Develop country/site specific ICF according to the core study ICF.4.Prepare the package for institutional review boards (IRB) and local regulatory authority submissions and obtain IRB/regulatory approvals for conducting the clinical trial.5.Perform and/or assist junior CRAs in site budget estimation and prepare/manage the clinical trial agreements with investigators/sites.6.Design project specific work sheets, tools, forms, logs and templates.7.Track, manage and control the site budget and expenses within approved budget and in line with the project milestones as requested.8.Manage/coordinate the investigational products and clinical trial materials for the sites in compliance with regulatory requirements.9.Monitor and report the project status at the sites in a timely manner.10.Key contact person for the communication between sites and study team.11.Prepare, arrange and conduct the training of site personnel.12.Conduct site initiation, monitoring and site close-out visits in compliance with monitoring plan, ICH-GCP, SOPs, local regulations and other applicable project-specific plans.13.Prepare monitoring report according to the SOP.14.Assist the investigator for auditing/inspection of project.15.Coordinate with the sites to ensure all adverse events and follow-up are appropriately reported and reconciled according to regulations.16.Identify, analyze and resolve the issues at the investigator sites.17.Assist in project quality management by accompanying junior CRAs during monitoring visits based on the requirements defined in the project specific plan.18.May sever as the project manager on potential project assigned by line manger.19.Take on additional responsibilities that may be assigned by line manager.Qualifications:1.A 4-year BS (Bachelor of Science) degree or equivalence experience. Advanced degree is a plus.2.3 years experience in clinical research environment.3.2 years experience in on-site monitoring and proven records in clinical study execution and GCP.Skills/Competencies:1.Good command of written and spoken English.2.Good organization and communication skills.3.Ability to manage multiple tasks.4.Good command of written and spoken English or other second language.5.Good organizational and communication skills.公司网站：http://www.apluscro.com/ 职能类别： 临床研究员 临床协调员 关键字： Senior Clinical Research Associate SCRA Senior CRA Home-based 周末双休 带薪年假

联系方式

上海(SHA)

公司信息

佳永医药咨询（上海）有限公司，是台湾佳生集团(PPC Group)旗下, 专责新药研发及临床试验的佳正国际股份有限公司(A+ Inc.) 在中国的分公司，台湾佳生集团成立于1997，是一家服务于亚太区制药企业，生物技术公司以及医疗器械公司的合同研究组织（CRO），主要提供新药研发的I – IV 期的临床试验服务。目前有员工580多人，主要分布在台北，首尔，东京和上海。 PPC集团网站 http://www.ppccro.com 佳永医药咨询（上海）有限公司网站：http://www.apluscro.com 公司地址：上海市长宁区仙霞路317号(远东国际广场B栋) 2516室

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