CTA-临床监察助理-SH 上海

月薪： 4.5-6千/月

该公司所有职位
  • 无工作经验
  • 本科
  • 招1人
  • 11-09 发布
  • 五险一金
  • 补充医疗保险
  • 餐饮补贴
  • 专业培训
  • 绩效奖金
  • 定期体检

职位描述

职位描述： GENERAL DESCRIPTION AND RESPONSIBILITIES:To perform non patient related duties and provide technical/logistical support to Clinical Research Department to ensure timely and efficient initiation, management and closure of clinical trials.As country clinical supplies administrator and under office head supervision to check drug room temperature weekly and handle supplies’ shipment with completed documentationSupport the tasks below for assigned project throughout the study:- Support for Trial Master File (TMF) maintenance in accordance with ICH-GCP and SOPs (SMART-KMS scanning, indexing and QC within prescribed timelines)- Updates the trial and site information as necessary in Clinical Trial Management System ( CTMS) –Trial Work® in a timely manner- Attends appropriate training programs and project teleconferences as applicable.- Support ethics committee & regulatory submissions- Support study team to upload essential document into SMART-KMSOther responsibilities of the CTA:- Complies with EPS INTL Policies, SOPs & IGs and local regulations during various projects related transactions- Provides back-up coverage for other CTA as necessary.- Supports Project Leader for production and tracking of trial metrics measurements.- Supports Project Leader for coordinating with sites for finalizing budget worksheets and contractual agreements .- Provides support as needed for drug management and finance management.- Maintains and ensures the availability of inventory for all non drug supplies.- Provides logistic and administrative support to project teams.- Responsible for distribution of SUSAR/safety letters to the sites, Ethics Committee and regulatory authority, if applicable- Supports CRA to track study budget in country and site level as applicable.- Provide logistic support for local PI meeting and CR related meeting/training. This job description does not list all duties of the job. Employees may be asked by supervisors or management to perform other duties.MINIMUM REQUIREMENTS:- Diploma or Degree in Life-Science from a recognized institutions, and/or equivalent combination of training and experience- Good coordination skills and ability to establish and maintain effective working relationships with all levels within the company and third parties.- Effective time management and good ability to manage competing priorities- Good communication skills and must be fluent in both written and spoken- EnglishGood team player with excellent interpersonal and organizational skills- High integrity in personality and professionalism- Positive attitude, high degree of initiative, committed and able to work independently- Self-initiative to perform duties, with good analytical and problem-solving capabilitiesAbility to handle multiple tasks and expected to follow through with completion of assigned tasks with minimal supervision- Meticulous and able to work in a fast-paced environment- Able to work under pressure and under challenging timelines when required- Excellent computer skills and proficient in Microsoft Word, Excel and PowerPointAble to travel when required 职能类别： 医药技术研发管理人员

联系方式

延安西路1326号生物大厦3楼

公司信息

CRO(Contract Research Organization)是指合同研究组织，为科研单位、制药企业的新药企业的新药开发提供临床试验的企划、运筹等一系列专业服务。随着GCP的运行、新药开发的国际化、特别是在欧美日本等先进国家，CRO以其极强的专业性、中立性、在新药开发中发挥着愈来愈重要的作用。 日本 EPS 株式会社（ EPS Co., Ltd. ）创业于1991年，是日本CRO领域起步早？规模大的CRO企业。2001年7月在日本东京证券市场成功上市，开创了CRO在日本上市的先例。 EPS集团在25年间有了迅速发展，目前已发展成为一个拥有30余家公司，其中两家日本上市企业，近4000员工覆盖全球各区域的跨国集团公司。 上海日新医药发展有限公司是EPS于2001年登陆中国市场，最早引入合同研究组织 (CRO)在华业务的公司。主要从事新药的I到IV期临床试验设计、实施、数据管理、统计分析和分析报告制作等业务，同时开展新药的注册、申报、医药咨询以及市场调研等业务。 本公司于2001年7月在上海正式注册成立，并在北京、广州设有分支机构。现公司设有业务开发、临床开发、注册事务、数据管理、统计分析、市场调查等部门。 凭借在日本从事CRO业务多年的经验，和EPS集团在日本、美国、中国大陆、中国台湾、新加坡等国家和地区的分公司和代表处的雄厚实力，日新公司成长为国内合同研究组织（Contract Research Organization）行业的领军者之一。我们基于中国，面向亚太地区，全面开展全球性的临床研究代理业务。 网址： http://www.eps.co.jp；http://www.epsi-global.com 福利制度介绍: 一 保险类： 1. 养老保险 2. 医疗保险 3. 失业保险 4. 工伤保险 5. 生育保险 6. 住房公积金 7. 补充医疗保险 8. 意外伤害保险 二 制度类： 1. 完整的教育训练 2. 透明化并顺畅的升迁管道 3. 生涯发展规划 4. 多元的海外工作机会 -请/休假制度： 1. 周休二日 2. 年假9-15天/年 3. 入职每满3年, 给予额外的5天长期服务休假奖励 三 其它： 1. 节庆礼品, 生日补贴, 2. 健康体检项目 3. 饭贴, 交通/通信补贴 4. Team Building活动及补助 5. 完善舒适的办公室环境及设备 6. 畅通的沟通渠道和和谐的团队 备注： 1） 请通过51job投递应聘简历，谢绝通过其他邮箱投递应聘简历，否则视为无效简历！！！ 2） 简历请不要以附件形式发送！！！

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