临床研究专员 II（基于合同）
Clinical Research Associate II (Contract based)
PSI 是一家领先的合同研究组织，在行业内已有30多年的历史，为客户提供稳定与创新的完美平衡，也为员工提供良好的工作环境。我们专注于在多种治疗适应症领域按时交付高质量的服务。
作为合同临床研究助理II，您将负责与项目相关方进行一线沟通，确保各种治疗适应症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机构和研究者的联系。您将关注受试者的权益、安全和福祉，以及数据合规性的质量。
居家办公（自由职业）
您将：
· 执行并报告所有类型的现场监查访问
· 参与研究启动
· 进行CRF审核、源文件验证和问题解决
· 负责机构沟通和管理
· 在国家层面监督研究活动、进度和时间表
· 作为内部支持服务和供应商的联系人
· 参与质量控制，如合规性监查和报告审核
· 参与可行性研究
· 协助监管团队准备研究提交文件
- 生命科学专业本科/大学学历，或同等教育、培训和经验组合
- 在葡萄牙有至少1年的独立现场监查经验
- 具有II期和/或III期所有类型监查访问的经验
- 具有IBD/炎症性肠病经验是必须的
- 英语和葡萄牙语具备全职工作水平的熟练度
- 熟练使用MS Office应用
- 能够计划、多任务处理并在动态团队环境中工作
- 具备沟通、协作和解决问题的能力
- 能够出差
做出正确的选择，将您的职业生涯提升到全新高度。加入这家重视人才并投资于其职业发展和成功的公司。
查看英文原文
PSI is a leading Contract Research Organization with more than 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 Contract Clinical Research Associate II, 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. You will focus on subjects’ rights, safety and well-being and quality of data compliance.
Home-based (freelance)
You will:
· Conduct and report all types of onsite monitoring visits
· Be involved in study startup
· Perform CRF review, source document verification and query resolution
· Be responsible for site communication and management
· Supervise study activities, timelines, and schedules on the country level
· Be a point of contact for in-house support services and vendors
· Be involved in quality control, such as compliance monitoring and reports review
· Participate in feasibility research
· Support regulatory team in preparing documents for study submissions
- College/University degree in Life Sciences or an equivalent combination of education, training & experience
- A minimum of 1 year of independent on-site monitoring experience in Portugal
- Experience in all types of monitoring visits in Phase II and/or III
- Experience in IBD/Inflammatory Bowel Diseases is mandatory
- Full working proficiency in English and Portuguese
- 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
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.