临床研究专员 II - 济南
Clinical Research Associate II - Jinan
当我们的价值观一致时，我们能够实现的成就没有界限。
在Parexel，我们都有相同的目标——改善全球健康。从临床试验到监管、咨询和市场准入，我们提供的每项临床开发解决方案都基于一种特别的东西——对所做工作的深刻信念。
无论我们在Parexel做什么，都在为最终能惠及患者的疗法开发做出贡献。我们把工作当作个人的事情来做，带着同理心，并致力于带来改变。
主要职责概要：
· 实施并监控临床试验，确保申办方和研究者义务得到履行，并符合适用的当地法规要求和ICH GCP指南。
- 评估潜在研究现场的资质，启动研究现场的临床试验，指导现场人员正确进行临床试验，并关闭研究现场的临床试验。
- 审核并验证收集的临床试验数据的准确性，无论是现场还是远程收集的。
- 向团队成员、试验管理人员提供定期的现场状态信息，并更新试验管理工具。
- 按照SOP或其他合同义务完成监查活动文档。
- 与其他临床团队成员密切合作，促进试验和/或临床问题的及时解决。
- 按照SOP上报现场和试验相关的问题，直到问题被解决或关闭。
- 执行关键文件现场文件核对。
- 执行源文件验证和问题解决。
- 评估研究用药品（IP）在研究现场的账目、分发和合规性。
- 根据试验方案和ICH GCP指南验证SAE报告。
- 与研究现场沟通。
- 更新相关的跟踪系统。
- 确保所有必要的培训已完成并记录。
- 作为现场活动的主要观察员/评估员。
- 协助审计和审计问题的解决。
- 承担其他合理相关的职责，根据经验和需要适时分配，例如方案修订提交、研究者现场预算谈判等。
- 指导初级CRAs，并作为新员工的资源支持。
- 作为现场活动的主要观察员，可能还承担一些职责。
查看英文原文
When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Key Role and Responsibilities Summary:
· Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH GCP guidelines.
- Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of
- clinical trials, and close clinical trials at investigative sites.
- Reviews and verifies accuracy of clinical trial data collected, either on site or remotely.
- Provides regular site status information to team members, trial management, and updates trial management tools,
- Completes monitoring activity documents as required by SOPs or other contractual obligations.
- Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues.
- Escalates site and trial related issues per SOPs until identified issues are resolved or closed.
- Performs essential document site file reconciliation.
- Performs source document verification and query resolution.
- Assesses investigational product (IP) accountability, dispensation, and compliance at the investigative sites.
- Verifies SAE reporting according to trial specifications and ICH GCP guidelines.
- Communicates with investigative sites.
- Updates applicable tracking systems.
- Ensures all required training is completed and documented
- Serves as main observer/assessor of site activities.
- Facilitates audits and audit resolution.
- To undertake other reasonably related duties as may be assigned from time to time as appropriate for experience and as required e.g. protocol amendment submissions, Investigator site budget negotiation.
- Mentors’ junior-level CRAs and serve as a resource for new employees.
- Serves as main observer of site activities and may have some responsibilities for performance of site.
- May be assigned additional clinical operations tasks.
- May serve as a resource for and interact with other functional areas to resolve site issues and facilitate trial timelines.
- May be assigned clinical tasks where advanced negotiating skills are required.
Originally posted on Himalayas