高级临床研究专员
Senior Clinical Research Associate
PSI 是一家在行业内拥有 30 年经验的领先合同研究组织，为客户提供稳定与创新相结合的完美平衡，同时也为员工提供良好的工作环境。我们专注于在多种治疗领域提供高质量且按时的服务。
作为高级临床监查员（Senior CRA），您将负责与项目相关方进行一线沟通，确保各种治疗领域的临床研究项目的进度、目标和标准。您将建立并维护与临床现场和研究者的联系。您的重点将放在受试者的权利、安全和福祉以及数据合规性的质量上。
这是一个位于斯洛伐克境内的自由职业（承包商）居家办公职位。
您的职责包括：
· 进行并报告所有类型的现场监查访问
· 执行病例报告表（CRF）审查、原始文件验证和问题解决
· 负责现场沟通和管理
· 监督每个现场的研究活动、进度和时间表
· 作为内部支持服务和供应商的联系人
· 支持质量控制，如合规性监查和报告审查
- 生命科学（或类似领域）学士或硕士学位，或同等教育、培训和经验组合
- 在斯洛伐克有独立的现场监查经验
- 具备 II 期和 III 期所有类型监查访问的可证明经验
- 斯洛伐克语和英语流利
- 有支持肿瘤学和胃肠病学研究的经验者优先
- 有效的驾驶执照及出差能力
- 熟练使用 Microsoft Office
- 具备沟通、协作和解决问题的能力是必需的
做出正确的选择，将您的职业生涯提升到全新高度。加入一家重视员工并投资于其职业发展和成功的公司。我们的招聘流程简单直接，我们将全程陪伴您每一步。我们会提供信息指导和支持，使您的体验尽可能顺畅。
查看英文原文
PSI is a leading Contract Research Organisation 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 Senior CRA, you will work on the frontline of communication with project stakeholders, ensuring timelines, targets and standards of clinical research projects in a variety of therapeutic indications. You will build and maintain relationships with clinical sites and investigators. Your focus will be on subjects’ rights, safety and well-being and quality of data compliance.
This is a freelance (contractor) home-based position from within Slovakia.
Your responsibilities will include:
· Conducting and reporting all types of onsite monitoring visits
· Performing CRF reviews, source document verification and query resolution
· Be responsible for site communication and management
· Supervising study activities, timelines, and schedules for each site
· Acting as a point of contact for in-house support services and vendors
· Supporting quality control, such as compliance monitoring and reports review
- BSc or MSc in Life Sciences (or similar), or an equivalent combination of education, training & experience
- Independent on-site monitoring experience in Slovakia
- Demonstrable experience in all types of monitoring visits in Phase II and III
- Fluency in Slovak and English
- Experience supporting Oncology and Gastroenterology studies is beneficial
- Valid driver's license and the ability to travel
- Intermediate to Advanced knowledge of MS Office
- Communication, collaboration, and problem-solving skills are essential
Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success. Our recruitment process is easy and straightforward, and we’ll be there with you every step of the way. We will guide and support you with information, making your experience as smooth as possible.