自由职业高级临床研究专员
Freelance Senior Clinical Research Associate
PSI 是一家领先的合同研究组织，拥有30年的行业经验，为客户提供稳定与创新的完美平衡，同时也为员工提供这样的环境。我们专注于在多种治疗领域提供高质量且按时的服务。
作为高级临床研究助理（Senior CRA），您将在与项目相关方沟通的一线工作，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站点和研究人员的关系。您的重点将是受试者的权利、安全和福祉以及数据合规性的质量。
这是一份在比利时的自由职业（承包商）职位。
您的主要职责包括：
· 进行并报告所有类型的现场监查访问
· 执行CRF审查、源文件验证和问题解决
· 负责站点的沟通与管理
· 监督每个站点的研究活动、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
- 生命科学学士或硕士学历（或类似专业），或教育、培训和经验的同等组合
- 在比利时有独立的现场监查经验，最好同时参与多个项目
- 具有II期和/或III期临床试验所有类型监查访问的实际经验
- 有支持肿瘤/血液病和传染病研究的经验
- 荷兰语和英语流利，法语专业水平
- 持有完整且无违规记录的驾驶执照，并具备出差能力
- 熟悉MS Office，达到中级到高级水平
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企业。我们的招聘流程简单直接，我们会全程陪伴您。我们将为您提供信息，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) position in Belgium.
Your main 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 Belgium, ideally on multiple projects at a time
- Demonstrable experience in all types of monitoring visits in Phase II and/or III
- Experience supporting Oncology/ Hematology and Infectious disease studies
- Fluency in Dutch and English, with professional proficiency in French
- Full and clean driver's license, and the ability to travel
- Intermediate to Advanced knowledge of MS Office
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.