临床研究助理II/高级CRA
Clinical Research Associate II/Senior CRA
PSI 是一家领先的合同研究组织，在行业内已有 22 多年的历史，为客户提供稳定与创新的完美平衡，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。
在 PSI 担任临床研究助理，您将参与多种现场监查任务，并在不同的治疗领域开展临床研究，保持行业最高质量标准。
您将：
· 进行并报告所有类型的现场监查访问
· 参与研究启动
· 执行 CRF 审核、源文件验证和问题解决
· 负责机构沟通与管理
· 作为内部支持服务和供应商的联系人
· 与内部项目团队沟通研究进展
· 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
- 在法国有独立的现场监查经验
- 有 II 期和/或 III 期临床试验中所有类型监查访问的经验
- 有肿瘤学、血友病、传染病、胃肠疾病经验
- 英语熟练
- 熟练使用 MS Office 应用程序
- 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
- 请以英文提交您的简历
这是一个进一步提升技能、拓宽治疗领域经验并成为临床研究专家的绝佳机会。
我们提供：
· 临床运营中的巨大职业发展机会，配有专门的导师和培训计划
· PSI 各部门之间的发展机会
· 灵活的工作时间
· 支持居家办公，以及居家与办公室结合的工作安排
· 丰富的入职培训和职业发展培训项目
· 高度发展的公司文化和积极的团队氛围
· 额外的休假天数（12 天 RTT）
· 请以英文提交您的简历
查看英文原文
PSI is a leading Contract Research Organization with more than 22 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:
· 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
· Be a point of contact for in-house support services and vendors
· Communicate with internal project teams regarding study progress
· 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
- Independent on-site monitoring experience in France
- Experience in all types of monitoring visits in Phase II and/or III
- Experience in oncology, hemophilia, infectious diseases, GI
- Full working proficiency in English
- 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
- Please submit your CV/resume in English
This is a great opportunity for you to further develop your skills, widen your therapeutic area experience, and become an expert in clinical research.
We offer:
· Big professional advancement opportunity within Clinical Operations with specific mentorship and training program
· Development opportunities across PSI departments
· Flexible working hours
· Home-office option available, as well as combination of home and office work arrangement
· Extensive onboarding trainings and professional development training programs
· Highly developed company culture and positive team atmosphere
· Additional leave days (12 days of RTT)
· Please submit your CV/resume in English