临床试验助理专员Clinical Trial Associate(CTA ) 武汉

月薪：

该公司所有职位
  • 2年经验
  • 本科
  • 招若干人
  • 11-09 发布

职位描述

职位描述： Position Purpose:To provide operational and logistical support to global early development programs and centralized TMF filing support to China portfolio in accordance with company SOPs, ICH GCP guidelines and local regulations. To be the primary point of contact where responsibility is held as a Subject Matter Expert for a business system. Organizational Relationships:· Report to CTA Lead · Partner with global COSTLs/ CROMs· Partner with local study teams· Partner with enabling functions as applicable Resources Managed (budget and FTEs):· Not applicablePrimary Duties:· 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.Training & Education:RequiredPreferred· Bachelor degree or above · Good English skills in writing and reading· Proficiency in basic computer literacy (e.g. Microsoft word, Excel and PowerPoint)· Science Background· Master degree· Experience in clinical trial administration· 2-3 years of clinical research experienceTraining and Relevant Experience:Preferred · 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 Technical Competencies:CompetencyDetail / Comments (specific skills, etc.)Concern for Quality and Compliance· Understand the quality expectations and emphasis on right first time· Demonstrate 100% compliance with all applicable company, regulatory and country requirementsOrganizational skills· Work independently and also as a team member· Ability to organize tasks, time and priorities, ability to multi-taskScientific/technical/administrative excellence· Understand basic medical terminology, GCP requirements and proficient in computer operationsSOP Compliance· Maintain knowledge and expertise on all relevant SOPsCommunication and presentation skills· Ability to communicate effectively and appropriately with internal & external stakeholdersOperational skills· Expertise in the current role and ability to handle more challenging tasks / role in a clinical trialAdministrative excellence· Attention to detail evident in a disciplined approach to document review, adherence to SOPs, metrics, etc.Behavioral Competencies:CompetencyDetail / Comments (specific skills, etc.)Interpersonal communications· Display sensitivity to manage relationships and ability to build collaborative working relationships with colleagues and associates both within and external to the organizationInfluencing· Demonstrate ability to introduce new ideas and drive the implementation· Effectively overcome barriers encountered during the implementation of new processes and systemsTeamwork· Be visible and well recognized across the Area for promoting collaboration across functional and geographic boundariesLearning organization· Seek to clarify feedback non defensively to understand required improvementCustomer Focus· Identify and build effective relationships with customers and other stakeholdersCultural awareness and sensitivity· Work well across country and area boundaries, respecting communication and cultural differences in interpersonal relationships 职能类别： 临床协调员 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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