Clinical Research Associate / Senior CRA
作为 PSI 临床研究合伙人，你将享受各种监测任务和在不同治疗指示中进行临床研究工作，保持行业最高质量标准。你将与有经验的临床研究专业人员合作，他们致力于质量，团队合作和促进临床研究。在乌克兰，你的责任包括：· 准备，开展和报告所有类型的监测访问，包括地点选择，启动，例行监控和接近访客 ·确保遵守研究协议，ICH-GCP 指导方针和法规要求 ·与调查人员和现场工作人员建立和保持密切关系 ·监督患者招聘，研究时间表和现象 ·执行源数据验证，追踪数据查询以及管理现场级风险 ·监督调查产品问责，试用物资和基本研究文档 ·维护调查员网站文件 (ISF) 和支持试题主文件 (TMF) 调整。·为研究人员和现场工作人员提供特定的培训 · 支持监管提交，审计准备和解决审计结果 · 博士学位，药学或士学位 · 在乌克兰拥有1年以上独立在现场监测经验 · 在第二阶段和/或第三阶段的所有类型的监控访问经验 · 癌症/性肠炎/抗生素试验的经验是个优点 · 全面熟练使用英语和乌克兰语言 · 掌握 MS 办公室应用程序 · 计划，多任务和动态团队环境中的工作能力 · 沟通，协作和解决问题的技能 · 旅行的能力 这是一个很好的机会，让你进一步发展你的技能，扩大你的治疗领域经验，成为临床研究专家。
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PSI is a leading Contract Research Organization with 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.
As a Clinical Research Associate at PSI, you will enjoy a variety of monitoring tasks and work on clinical studies in different therapeutic indications, maintaining the highest quality standards in the industry. You will be collaborating with experienced clinical research professionals who are committed to quality, teamwork, and advancing clinical research.
Remote role in Ukraine
Your responsibilities will include:
· Preparing, conducting, and reporting on all types of monitoring visits, including site selection, initiation, routine monitoring, and close-out visits
· Ensuring compliance with study protocols, ICH-GCP guidelines, and regulatory requirements
· Building and maintaining strong relationships with investigators and site staff
· Monitoring patient recruitment, study timelines, and site performance
· Performing source data verification, following up on data queries, and managing site-level risks
· Overseeing investigational product accountability, trial supplies, and essential study documentation
· Maintaining Investigator Site Files (ISF) and supporting Trial Master File (TMF) reconciliation
· Delivering study-specific training to investigators and site staff
· Supporting regulatory submissions, audit preparation, and resolution of audit findings
- MD, PharmD or MSc
- 1+ year of independent on-site monitoring experience in Ukraine
- Experience in all types of monitoring visits in Phase II and/or III
- Experience in Oncology/Ulcerative Colitis/Antibiotics trials is a plus
- Full working proficiency in English and Ukrainian
- Proficiency in MS Office applications
- Ability to plan, multitask and work in a dynamic team environment
- Communication, collaboration, and problem-solving skills
- Ability to travel
This is a great opportunity for you to further develop your skills, widen your therapeutic area experience, and become an expert in clinical research.