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Open nowFirst seen 4 days ago

Clinical Applications and Validation Specialist

Lifelancer3,738 open roles

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This job: first seen 4 days ago

The posting

Job Title: Clinical Applications and Validation Specialist

Job Location: 美国加利福尼亚洛杉矶

Job Location Type: On-site

Job Contract Type: Full-time

Job Seniority Level: Mid-Senior level

Pythia Health正在招聘一名临床应用与验证专员，以支持其高效ctDNA甲基化检测平台在临床研究中心、医疗机构和实验室的验证活动。该职位将作为实验室医生、研究协调员、人员和Pythia内部团队之间的技术和操作桥梁。该职位将协助确保验证研究、样本流程、现场实施和技术培训工作的准确完成。

主要职责：

1、在检测验证活动期间驻实验室守门。

2、协调验证计划、样本、测试工作流程、文档和问题解决。

3、与实验室人员合作，确保验证方案得到一致执行。

4、跟踪验证文件、差异、重复测试和待办事项。

5、协助记录验证结果，并整理支持性记录，满足内部、监管和质量管理要求。

5、向Pythia的科学和临床领导层传达技术问题和实验室发现。

6、在入职、激活和招募期间为参与的医疗机构和临床试验中心提供支持。

7、为医生、护士、研究协调员、采血员和实验室工作人员提供检测和研究流程方面的培训。

8、解答有关检测方法、采集试剂盒、样本要求、处理、储存、包装和运输的技术问题。

9、确保各研究中心拥有所需的试剂盒、耗材、说明书和运输材料。

10、监控从医疗机构接收样本的采集和运输过程。

11、识别并可能影响样本质量、方案依从性、周转时间或研究进入的问题操作。

12、协调临床研究中心、实验室验证和Pythia内部团队之间的工作。

13、协助编写标准操作程序、培训指南、验证文件和常见问题解答。

14、将医疗、科学、法规或质量方面的问题上报给相应团队成员。

优先考虑的资格：

1、医学检验科学、生物学、分子生物学、护理学、临床研究或相关领域的学科。

2、具有分子诊断、实验室验证、肿瘤学、临床试验或医疗器械方面的经验。

3、熟悉PCR、ctDNA、甲基化检测、样本处理和实验室体系质量。

4、具有验证方案、实验室文档或检测实施方面的工作经验。

5、具备向实验室和临床团队解释复杂技术信息的能力。

6、消耗往返于各个实验室和医疗机构之间。

This job is curated by Lifelancer.

Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.

Please apply via Lifelancer platform to get connected to the application page and to find similar roles.

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