CTA 2
CTA 2
职位名称:CTA 2
工作地点:英国伯克郡雷丁
工作地点类型:远程
工作合同类型:全职
职位级别:
与研究助理、监管和启动团队合作,确保完整准确地交付试验主文件。
主要职责
- 协助临床研究助理(CRAs)和监管及启动(RSU)团队准确更新和维护临床文档和系统(例如试验主文件(TMF)),以跟踪项目时间表内的站点合规性和表现。
- 协助临床团队根据工作范围和标准操作程序准备、处理、分发、归档和保存临床文档和报告。
- 协助定期审查研究文件的完整性。
- 协助 CRAs 和 RSU 准备、处理和分发临床试验物资,并维护追踪信息。
- 协助跟踪和管理病例报告表(CRFs)、查询和临床数据流程。
- 作为临床团队在指定项目中的主要联系人,负责沟通、信函及相关文档。
- 在完成必要培训后,可能陪同 CRAs 进行现场访问,协助临床监查工作。
任职要求
• 高中毕业或同等学历
- 3 年行政支持经验。
• 相关教育、培训和经验的等效组合。
- 计算机技能,包括对 Microsoft Word、Excel 和 PowerPoint 的熟练使用。
- 书面和口头沟通能力,英语水平良好。
- 有效的时间管理和组织能力。
- 能够与同事、经理和客户建立并维持良好的工作关系。
- 了解适用的临床研究法规要求,如良好临床实践(GCP)和国际协调会议(ICH)指南,具体以公司培训内容为准。
- 了解适用的方案要求,具体以公司培训内容为准。
IQVIA 是生命科学和医疗行业领先的临床研究服务、商业洞察和医疗健康智能提供商。我们创建智能连接,加速创新医疗方案的研发和商业化,以帮助改善全球患者的治疗结果和人群健康。了解更多,请访问
IQVIA 致力于在招聘过程中保持诚信。
查看英文原文
Job Title: CTA 2
Job Location: Reading, Berkshire, United Kingdom
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level:
Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery.
Essential Functions
- Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines.
- Assist the clinical team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
- Assist with periodic review of study files for completeness.
- Assist CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
- Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.
- Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
- May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training.
Qualifications
• High School Diploma or equivalent Req
- 3 years administrative support experience.
• r.
- Equivalent combination of education, training and experience.
- Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint.
- Written and verbal communication skills including good command of English language.
- Effective time management and organizational skills.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
- Awareness of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines as provided in company training.
- Knowledge of applicable protocol requirements as provided in company training.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
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Originally posted on Himalayas