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3-4年经验 -
本科 -
招若干人 -
11-09 发布
职位描述
职位描述： Major Responsibilities and Duties:1. Perform all clinical monitoring/site management activities for assigned projects in accordance with Zai's standard operating procedures2. Act as Zai's direct contact with assigned clinical sites, and use judgment to assess and ensure overall integrity of study implementation, as well as adherence to study protocol3. Conduct qualification visits (QV), site initiation visits (SIV) and monitoring visits (MV) at assigned clinical sites4. Good knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines5. Function as a mentor and role model for other CRA team members6. Manage clinical monitoring activities, including:-Arranging on-site visits and logistics-Establishment of a site recruitment plan in collaboration with site staff during QV-Monitoring completeness and quality of Regulatory Documentation-Performing site documentation verification-Data collection and drug accountability in accordance with ICH GCP guideline-Monitoring patient safety on-site and addressing any violations in a timely manner7. And other tasks assigned by the companyQualifications:1. Minimum 2 years of monitoring experience in clinical research2. Educated to degree level (biological science, pharmacy or other health related discipline)3. Strong working knowledge of EDC systems and IVRS4. Experience in global pharma company or global CRO preferred5. Competent in written and oral English and local language 职能类别： 临床研究员 临床数据分析员 关键字： 临床 试验 监察
联系方式
金科路4560号金创大厦1号楼4楼
公司信息
ZAI Lab is a leading biotech company based in China focused on discovering and developing innovative medicines for unmet medical needs globally. The company is building a strong portfolio of therapeutic programs aimed at transforming patients’ lives. Zai Lab has a world class leadership team with deep experience at global pharmaceutical and biotech organizations. The team has a strong track record of success – successfully taken five novel drug candidates into clinical trials in China, pioneered new regulatory channels, secured regulatory approvals in record times, conducted multiple IND trials in the US, and brought the first China discovered drug into Global Phase III trials. Zai Lab is committed to build a globally leading drug research and development powerhouse with a culture of excellence and teamwork and a strong focus on fostering innovation and creativity. For more information, please visit www.zailaboratory.com.
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