In-House Clinical Research Associate I / II - Spanish / English / Portuguese (
加入全球合同资源组织 (CRO),创新达到目的。在世界临床试验中，我们以通过高质量的临床研究改善生活的共同承诺为动力。我们的团队有能力创造性地思考，拥有权力，并提供有意义的工作，帮助将改变患者的生活治疗带来给世界各地的病人。与全球4000多名专业人士，我们培养了一个协作和包容性的环境，在那里各种观点得到了重视，鼓励增长，每一个贡献都产生了影响。无论你正在建立自己的职业生涯还是带来多年的经验，你都将有机会学习，成长和帮助塑造临床研究的未来。作为全球医疗研究员，在支持整个研究生命周期中有效地管理临床研究进行进步。在这个角色上，你将与临床试验管理人员，实地临床研究伙伴，研究地点和跨功能项目团队密切合作，以帮助准确及按时执行现场活动。你将在整个网站管理中广泛参与，从研究启动和基本文件到远程监测，数据审查，招聘支持和研究接近。你的工作将帮助网站保持准备，信息和符合良好临床实践 (GCP),适用的规定和学习要求。在哪里你会工作 这是一个远程职位为位于阿根廷或巴西的候选人开放。你将与多个时区内的全球团队合作。你将做什么 · 在整个研究生命周期内支持站点管理活动，包括可行性，研究开始，临时和远程监控以及适当指导下完成的关闭活动。· 定期与分配的网站进行沟通，并与临床试验管理人员和现场 CRA 合作，以保持研究活动和成果在轨。· 对质量和完整性审查站点文档，支持试验主文件 (TMF) 的提交和调整，帮助维护调查者站点文件 (ISF). · 检查电子数据捕获 (EDC)记录，完成逻辑和合规，协助站点解决数据管理和供应商询问卷。·通过跟踪和传达行动项目，协议偏差，未到期的查询，研究用品，培训和其他开放的活动来准备 CRA 访问现场。·协调。
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Join a global Contract Resource Organization (CRO) where innovation meets purpose. At Worldwide Clinical Trials, we're driven by a shared commitment to improving lives through high-quality clinical research. Our teams are empowered to think creatively, take ownership, and deliver meaningful work that helps bring life-changing therapies to patients around the world.
With more than 4,000 professionals across the globe, we foster a collaborative and inclusive environment where diverse perspectives are valued, growth is encouraged, and every contribution makes an impact. Whether you're building your career or bringing years of experience, you'll have the opportunity to learn, grow, and help shape the future of clinical research.
Make an Impact as a In-House Clinical Research Associate at Worldwide
Help keep clinical studies moving forward by supporting effective site management throughout the study lifecycle. In this role, you’ll work closely with Clinical Trial Managers, field Clinical Research Associates, study sites, and cross-functional project teams to help deliver site activities accurately and on schedule.
You’ll have broad involvement across site management, from study start-up and essential documentation through remote monitoring, data review, recruitment support, and study close-out. Your work will help sites stay prepared, informed, and aligned with Good Clinical Practice (GCP), applicable regulations, and study requirements.
Where You'll Work
This is a remote role open to candidates based in Argentina or Brazil. You will collaborate with global teams across multiple time zones.
What You'll Do
- Support site management activities throughout the study lifecycle, including feasibility, study initiation, interim and remote monitoring, and close-out activities under appropriate guidance.
- Maintain regular communication with assigned sites and partner with Clinical Trial Managers and field CRAs to keep study activities and deliverables on track.
- Review site documentation for quality and completeness, support Trial Master File (TMF) filing and reconciliation, and help maintain Investigator Site Files (ISFs).
- Review electronic data capture (EDC) records for completion, logic, and compliance, and assist sites with resolving data management and vendor queries.
- Prepare CRAs for site visits by tracking and communicating action items, protocol deviations, outstanding queries, study supplies, training, and other open activities.
- Coordinate study materials, support site staff changes and system access, and help ensure required training, qualifications, delegation, and regulatory documentation remain current.
- Support site prescreening, screening, recruitment, and Subject Eligibility Review tracking, as applicable to the study.
- Maintain study trackers, pull information from study-specific portals and systems, and provide timely updates to Clinical Trial Managers and project teams.
- Serve as a key operational contact for clinical research activities when appropriate, helping sites and study teams address issues and maintain progress.
What You'll Bring
- A four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy, or another related science is preferred; alternatively, a two-year college curriculum or equivalent education/training plus at least one year of relevant clinical research experience, or other relevant education/training plus at least two years of clinical research experience, may be considered.
- A basic understanding of clinical research principles and processes, with knowledge of applicable FDA and/or EU regulations, ICH Guidelines, local regulatory requirements, and standard operating procedures.
- Strong written and verbal communication skills, with the interpersonal skills to work effectively with sites and cross-functional study teams.
- Good planning, organization, and time-management skills, with a methodical approach to managing multiple activities.
- Basic knowledge of Microsoft Office and familiarity with IVRS and electronic CRF systems.
- Proficiency in spoken and written English + Spanish + Portuguese along with fluency in the local languages of the countries under your responsibility.
Discover the Difference
We love knowing that someone is going to have a better life because of the work we do. Discover the Difference at Worldwide Clinical Trials. Explore additional opportunities on our careers page, visit , or connect with us onLinkedIn.
Originally posted on Himalayas