临床试验助理(CTA)/CTC_马德里_客户专属
Clinical Trial Assistant (CTA)/CTC_Madrid_Sponsor dedicated
临床试验助理(CTA)/CTC_马德里_申瑞健康®是一家领先的全集成生命科学服务组织,致力于加速客户成功。我们与药物开发和商业化全过程中的创新者合作,帮助他们应对复杂性、预见变化并加快进展。
我们的临床解决方案团队成员以药物开发的思维开展工作,运用多年的经验和专业知识,真正理解客户需求,并在我们打造的解决方案中代表这些需求。
无论您加入我们作为功能服务提供商合作伙伴还是全服务环境的一员,您都将与充满热情的问题解决者协作,作为一个团队进行创新,帮助我们的客户实现目标。我们敏捷且有动力去完成任务——为了彼此、我们的客户,以及最重要的是,为了那些需要帮助的人。
了解您的25,000名未来同事已经知道的内容:
为什么选择申瑞健康
• 我们致力于员工发展,通过职业发展和晋升;支持性的、积极参与的直线管理;技术和治疗领域培训;同行认可和全面奖励计划。
• 我们致力于建设一个包容的文化——您可以真实地做自己。这与我们的使命密切相关——Driven to Deliver(致力于交付),体现了我们员工每天展现的热情,塑造能够显著影响他人生活的解决方案。
• 我们不断打造我们所有人都希望工作的公司,也是客户希望合作的公司。为什么?因为我们知道,当我们将来自世界各地的聪明同事聚集在一起,我们可以塑造医疗健康的未来,为客户带来影响,并定义患者进展的速度。
职位职责
- 负责按照适用的公司和临床运营政策、标准操作规程和工作说明执行相关活动
- 协助临床监查人员进行站点管理活动,包括作为指定研究的申办方代表与站点沟通,确保符合方案要求、研究程序和相关指南
- 创建并协助维护试验主文件(TMF)和项目文件,包括参与文件审计
- 准备和维护站点手册、参考工具和其他文档
- 维护、更新并输入临床跟踪信息
查看英文原文
Clinical Trial Assistant (CTA)/CTC_Madrid_Sponsor dedicatedSyneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.
Discover what your 25,000 future colleagues already know:
Why Syneos Health
• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.
Job Responsibilities
- Responsible for performing activities in compliance with applicable Corporate and Clinical Operations Policies, Standard Operating Procedures and Work Instructions
- Assists Clinical Monitoring staff with site management activities, including serving as a Sponsor representative for sites on assigned studies, and communicating with sites to ensure compliance with protocol requirements, study procedures and relevant guidelines
- Creates and assists with maintenance of Trial Master File (TMF) and project files, including participation in file audits
- Prepares and maintains site manuals, reference tools and other documents
- Maintains, updates, and inputs clinical tracking information into databases
- Tracks incoming and outgoing clinical and regulatory documents and updates for investigator sites, studies, project team, or client
- Manages shared mailbox, processes site requests and routes correspondence appropriately
- Coordinates the ordering, packaging, shipping and tracking of site supplies and materials
- Assists with coordination of team meetings, attends meetings and prepares accurate meeting minutes and action items
- May handle receipt, tracking and disposition of Case Report Forms and Queries
- Maintains overall awareness in the field of clinical research by completing all necessary and assigned training
Qualifications:
- High School diploma or equivalent
- Previous experience on the role (2-3 years)
- Fluent Englsih
- Good communication and interpersonal skills
- Ability to embrace new technologies
- Minimal travel up to 25% may be required
Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
Additional Information
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Originally posted on Himalayas