临床研究助理
Clinical Research Associate
PSI 是一家领先的合同研究组织，拥有超过 30 年的行业经验，为客户提供稳定与创新相结合的完美平衡，也为员工提供良好的工作环境。我们专注于在多种治疗领域提供高质量且按时的服务。
作为 PSI 的临床研究助理，您将参与多种现场监查任务，并在不同治疗领域的临床研究中工作，保持行业最高质量标准。
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
· 负责站点沟通与管理
· 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
· 支持并参与审计和检查
- 生命科学专业或同等教育、培训和经验组合的大学/学院学位
- 至少 1 年独立现场监查经验
- 具备所有类型监查访问经验
- 英语和塞尔维亚语具备全职工作水平
- 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
- 沟通、协作和解决问题的能力
- 能够在该地区出差
- 有效的驾驶执照
我们提供的福利：
· 稳定性，长期合作
· 正式合同，全职工作
· 远程办公环境
· 汽车补贴、笔记本电脑和手机
· 职业发展
· 团队协作与独立工作的独特结合
· 友好且支持性的同事
· 临床研究行业的入职课程
· 指导和在职培训
· 在巴尼亚卢卡舒适的办公室和团队支持
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.
This position requires relocation to Trebinje area in Bosnia and Herzegovina.
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
· Support and participate in audits and inspections
- College/University degree in Life Sciences or an equivalent combination of education, training & experience
- The candidate should meet the requirements for a CRA/monitoring position in Bosnia and Herzegovina
- At least 1 year of independent on-site monitoring experience
- Experience in all types of monitoring visits
- Full working proficiency in English and Serbian
- 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 across the region
- Valid driver’s license
What We Offer:
· Stability, long-term cooperation
· Permanent contract, full-time job
· Remote work setting
· Car allowance, laptop and mobile phone
· Career development
· Unique combination of team collaboration and independent work
· Friendly and supportive colleagues
· Onboarding courses about clinical research industry
· Mentoring and on-the job training
· Comfortable office and team support in Banja Luka
This is a great opportunity for you to further develop your skills, widen your therapeutic area experience, and become an expert in clinical research.