临床研究专员II
Clinical Research Associate II
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。
在 PSI 担任临床研究助理，您将参与多种监查任务，并在不同治疗领域开展临床研究，同时保持行业最高质量标准。
您将：
· 作为项目团队、申办方和研究现场之间的主要沟通渠道
· 与参与研究实施的现场工作人员建立并维护良好的关系
· 准备、执行并报告现场选择、启动、常规监查和结束访问
· 确保受试者招募目标及时制定、传达、记录并达成，同时在现场层面遵循项目时间表
· 确保不良事件和方案/流程偏离信息在试验现场的准确和及时传递
· 执行源数据验证，并跟进现场的数据查询；在现场层面审查和管理研究风险
· 确保所有试验药物（Investigational Product）和临床研究物资在现场的正确处理、使用、责任归属、对账和归还
· 审查关键研究文件，并在现场层面协调研究者现场文件（ISF）/试验主文件（TMF）
· 确保现场层面的质量（数据完整性和合规性）
· 进行现场审计准备访问并解决现场审计发现的问题
· 参与研究现场审计和客户现场访问，根据需要
· 确保项目团队、现场和中心/区域实验室/中心评审员/仓库之间的文件和研究物资流动
· 对现场研究者进行项目特定培训
· 协助准备研究者简报
· 协助现场管理助理在现场层面维护研究特定和公司跟踪系统
· 协助准备监管和伦理委员会提交包的草案
· 协助在现场/国家层面收集 IP-RED 包
· 协助在国家和现场层面审核和对账研究 TMF
- 生命科学相关专业本科/大学学历，或同等教育、培训和经验组合
- 优先考虑位于中部或西海岸地区的候选人
- 必须有 2 年以上独立现场监查经验
- 具有各种类型监查访问的经验
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 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:
· Act as the main line of communication between the project team, sponsor, and the site
· Build and maintain a good relationship with the site staff involved in the study conduct
· Prepare, conduct, and report site selection, initiation, routine monitoring and close-out visits
· Ensure that subject recruitment targets are timely defined, communicated, recorded and met, and project timelines are followed at site level
· Ensure accurate and timely information flow with trial sites on Adverse Events and protocol/process deviations
· Perform source data verification and follows up on data queries at site level; review and manage study risks on a site level
· Ensure proper handling, use, accountability, reconciliation, and return of all Investigational Product(s) and clinical study supplies on sites
· Review essential study documents and reconcile study Investigator Site File (ISF) / TMF at site level
· Ensures quality (data integrity and compliance) at site level
· Conduct site audit preparation visits and resolve site audit findings
· Participate in study site audits and client onsite visits, as required
· Ensure the flow of documents and study supplies between the project team, site and the Central/ Regional Laboratory/ Central Reviewer/ Warehouse
· Conduct project-specific training of site investigators
· Support preparation of Investigator newsletters
· Assist Site Management Associates in maintaining study-specific and corporate tracking systems at site level
· Support preparation of draft regulatory and ethics committee submission packages
· Support collection of IP-RED packages at site/country level
· Facilitate review and reconciliation of the study TMF on country and site levels
- College/University degree in Life Sciences or an equivalent combination of education, training & experience
- Located in the Central or West Coast regions is preferred
- Must have 2+ years of independent on-site monitoring experience
- Experience in all types of monitoring visits, in phases I-III
- Experience in Oncology mandatory & GI preferred and/or radio-pharm experience preferred.
- 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 up to 75%
- Valid driver’s license (if applicable)
- For this position PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future.
This is a great opportunity for you to further develop your skills, widen your therapeutic area experience, and become an expert in clinical research.
For this position, PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future.