上海招聘

Position objective:
Responsible transferring data from source documents to Case Report Form (CRF) or Electronic Data Capture (EDC) system. This team member maintains accurate CRF, EDC, Sources documents and regulatory files as well as archiving completed study records. In addition, the CRA will act as host for the monitors from sponsors who conduct periodic audits of the study files.

Major responsibilities:
1. Work directly with the Head of Clinical Operations to coordinate study related visits and audit activities.
2. Understand protocols and procedures requirements. Understand the data handling guidance as per sponsors’ requests. Familiar with and be able to use the electronic data capture system and electronic medical record.
3. Oversee assigned clinical trials to ensure compliance with the highest standards of GCP and according to SOPs. Performs source document verification of subject data and query resolution.
4. Transfer data from source documents to CRF or EDC. Ensure the resolution to all queries as per data handling guidance.
5. Process incoming correspondence including, but not limited to safety reports, IRB, Sponsor Correspondence, etc, as necessary. Communicate with the appropriate physician and obtain the necessary signature, in accordance with IRB requirements or SFDA regulations. Follow up as necessary.
6. Participate in regularly scheduled teleconferences regarding research studies. Responsible for taking notes and disseminating to the research team as appropriate.
7. Assist Head of Clinical Operations with preparation of study budget. Track study payments to ensure payments are on time and within budget.
8. Collect, review, and monitor required regulatory documentations for study startup, study maintenance and study closeout. Ensure site study materials are current and maintained up to internal SOPs.

Competency/Quality Requirement:
1. Medical School Graduate or equivalent.
2. Strong project management skill, ability to manage project activities with attention to details
3. Preferably with 2 years clinical research working experiences or data management experiences
4. Fluent spoken and written English capabilities with excellent communication skills, preferably CET 6 level
5. Willingness to take on new challenges and think with flexibility
6. Proficiency in Basic Microsoft Word and Excel and familiarity with use of database.
7. Customer focus and teamwork.



职位综述：
负责将原始数据录入到CRF或EDC系统中，保证CRF、EDC、源文件、法规文件和研究记录准确完整。此外，还负责与申办方监察员沟通。

主要职责：
1. 协助临床运营经理协调研究相关的访视和审查工作；
2. 理解方案和程序要求，并按每个申办方的要求指导数据处理。熟悉并能使用电子数据采集系统和电子病历系统；
3. 监督临床试验，确保试验按照高质量GCP和SOP进行。核查原始文件确保数据准确；
4. 将原始数据录入至CRF或EDC系统，并确保数据的规范和准确；
5. 研究相关的联络沟通工作，包括但不限于：安全报告、IRB、申办方人员等。与医生沟通并获得需要的签字。

任职主要要求：
1. 临床医学专业本科或以上学历；
2. 能够管理项目进程并注重细节；
3. 具2年以上的临床研究经验或数据管理经验优先。

始达（上海）医药科技有限公司

始达（上海）医药科技有限公司于2011年9月正式成立。公司致力于临床试验机构管理服务，尤其是抗肿瘤药物早期临床试验的管理。公司的使命是通过高效高质的管理服务，加速创新药物的研发，目标是成为中国临床试验机构的***合作伙伴以及机构管理服务领域的标杆企业。
2011年创立至今，公司分别与多家研究机构合作，协助研究中心进行各临床试验项目的启动前期准备、启动、实施、结束的各项工作。从医学撰写、中心培训、独立质控、项目管理、招募分流、项目协调、数据录入、样本管理等几个维度对临床试验进行嵌入式的管理。
始达欢迎有志迎接新挑战、新机遇，有创业精神的人士加入始达医药，在帮助社会的同时实现自我价值的提升。


请将中英文简历发至邮箱：min.zhou@startshanghai.cn
联系人：董琪
电话： 13524116560