临床试验助理Clinical Trial Assistant 武汉

月薪：

该公司所有职位
  • 无工作经验
  • 本科
  • 招若干人
  • 11-09 发布

职位描述

职位描述： Zone / Line: Pfizer(Wuhan) Research and Development Center, CTA Responsibility: · Provide protocol and ICD administrative support to global Clinical Operations Study Team Leads (COSTLs) and Clinical Research Operations Managers (CROMs), including but not limited reviewing the consistency of documents, prepare RighTrack II protocol outputs report, circulate and track the approval status. · Request set up of study team SharePoint spaces, grant access to the team and update files in SharePoint for Inspection Readiness documents including team roster changes, , updating version dates etc., and uploading of meeting minutes and any documents to SharePoint as required. · File documents to PTMF/ GDMS. · Maintain Pfizer Trial Master File (PTMF) in accordance with ICH-GCP and SOPs. Update the trial and site information as necessary in Corporate Clinical Trial Registry (CCTR) in a timely manner · Assist team with the preparation of any documents upon request, including but not limited to vender oversight plan, correspondence with investigator sites and vendors, study specific manuals for the sites, etc. · Track and update all information on an ongoing basis per request, including but not limited to site contact information, required site training attendance, vender information, patient recruitment, trial suppliers, payment schedule, Ariba orders, etc. · Attend appropriate training programs and project teleconferences as applicable. · Assist COSTLs/CROMs on preparing investigator meetings if required. · Support and coordinate any activities as requested by COSTLs/ CROMs and as assigned within required timelines. Qualification: · Bachelor degree or above · Good English skills in writing and reading · Proficiency in basic computer literacy (e.g. Microsoft word, Excel and PowerPoint) · Knowledge of ICH GCP and local regulations · Experience in management of clinical trial and/or regulatory documents · Knowledge of application used in the clinical trials 职能类别： 临床研究员 临床数据分析员

联系方式

光谷生物城

公司信息

On October 31, 2005, Pfizer announced the official opening of China Research and Development Center (CRDC) in Shanghai. Pfizer Global Research and Development’s Center is mainly engaged in drug development activities. Much of the facility's capacity is devoted to the study design, data management and statistical analysis of global phase I-IV clinical trials, as well as the clinical study report process. In addition, CRDC is a part of Pfizer global Safety and Risk Management and covers the functions of safety data processing and assessment. The center also trains Pfizer employees in China and throughout the Asia region in internationally recognized Good Clinical Practice standards. 辉瑞公司于2005年10月31日宣布辉瑞中国研发中心正式在上海揭幕。辉瑞中国研发中心主要为全球辉瑞药物开发提供支持工作。大部分的功能是围绕在I-IV期临床试验研究设计、数据管理和生物统计分析、以及临床试验报告的部分准备工作。此外，该中心是辉瑞全球安全和风险管理部的一个分支，负责安全数据处理和评估工作。研发中心还将为辉瑞公司在中国及亚洲的其它运营部门的员工提供国际标准的临床试验管理规范(GCP)的技术培训。

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