高级临床监查员/SCRA
再鼎医药（上海）有限公司
- 公司规模：500-1000人
- 公司性质：外资（非欧美）
- 公司行业：制药/生物工程
职位信息
- 发布日期：2017-12-05
- 工作地点：上海-浦东新区
- 工作经验：3-4年经验
- 学历要求：本科
- 语言要求：英语精通 普通话精通
- 职位月薪：1-1.5万/月
- 职位类别：临床研究员 临床数据分析员
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 procedures
2. 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 protocol
3. Conduct qualification visits (QV), site initiation visits (SIV) and monitoring visits (MV) at assigned clinical sites
4. Good knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
5. Function as a mentor and role model for other CRA team members
6. 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 manner
7. And other tasks assigned by the company
Qualifications:
1. Minimum 2 years of monitoring experience in clinical research
2. Educated to degree level (biological science, pharmacy or other health related discipline)
3. Strong working knowledge of EDC systems and IVRS
4. Experience in global pharma company or global CRO preferred
5. Competent in written and oral English and local language
Major Responsibilities and Duties:
1. Perform all clinical monitoring/site management activities for assigned projects in accordance with Zai's standard operating procedures
2. 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 protocol
3. Conduct qualification visits (QV), site initiation visits (SIV) and monitoring visits (MV) at assigned clinical sites
4. Good knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
5. Function as a mentor and role model for other CRA team members
6. 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 manner
7. And other tasks assigned by the company
Qualifications:
1. Minimum 2 years of monitoring experience in clinical research
2. Educated to degree level (biological science, pharmacy or other health related discipline)
3. Strong working knowledge of EDC systems and IVRS
4. Experience in global pharma company or global CRO preferred
5. 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
公司介绍
Zai Lab is an innovative biopharmaceutical company based in Zhang Jiang, Shanghai focused on bringing transformative medicines for cancer, autoimmune and infectious diseases to patients in China and around the world. Zai Lab focus on innovation to meets the unmet medical needs. Zai has built up a strong pipeline with multiple programs on clinical stages. Zai Lab successfully listed on Nasdaq in Sep. 2017.
再鼎医药是一家总部设立于上海张江，致力于研究、开发和销售创新药物的制药企业。再鼎医药针对目前尚无良好治疗手段的疾病领域开发新药，在肿瘤、抗感染、自身免疫等方面建立了全面的产品线，服务中国和全球病患。再鼎医药于2017年9月在美国纳斯达克成功上市。
再鼎医药是一家总部设立于上海张江，致力于研究、开发和销售创新药物的制药企业。再鼎医药针对目前尚无良好治疗手段的疾病领域开发新药，在肿瘤、抗感染、自身免疫等方面建立了全面的产品线，服务中国和全球病患。再鼎医药于2017年9月在美国纳斯达克成功上市。
联系方式
- 公司地址：地址：span上海浦东张江高科技园区金科路4560号金创大厦3号楼8楼