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, and validate Sources documents. In addition, the DMS 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 validation 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. Receives and requests data from patient records; complete s(as appropriate) paper and electronic case report forms(CRFs).
6. Reviews patient data for completeness and accuracy.
7. Identifies, enters and evaluates the Adverse Events(AEs)in CRFs(as appropriate).
8. Performs data entry and transmits data to sponsors as required.
9. Coordinates and schedules monitor(s) visits.
10. Meets with sponsor/monitors to review casebook. Provides support and information to monitors as necessary and as directed by supervisor(s). Assists in retrieval of data for eligibility packets for Project Manager as appropriate.
11. Retrieves missing data promptly to insure completeness of CRFs.
12. Identifies normal lab values a n d certifications to be requested for study files
13. Assures that data entry remains current for all studies per SOP.
14. Maintains a study tracking file for each assigned study and communicates as needed with accounts receivable staff regarding submitted data.
15. Attends meeting and briefing regarding clinical studies as required.
16. Assists in the guidance and training of less experienced staffs
17. Translate medical records from Chinese to English per study requirement

Competency/Quality Requirement:

1. Medical School Graduate or equivalent
2. Preferably with 2 years clinical research experiences as CRA or data management function
3. Demonstrated ability to accurately and efficiently complete assignments in Clinical Investigations and demonstrated capability to perform the data review and CRF completion in its entirety with minimal direction.
4. Fluent spoken and written English capabilities with excellent communication skills, especially in medical area, preferably CET 6 level
5. Willingness to take on new challenges and think with flexibility
6. Proficiency in MS offices and familiarity with use of electronic database.
7. Customer focus and teamwork.
8. Self-motivation


职位描述：
负责将原始文件传输到CRF或EDC系统中，并维护CRF、EDC和各类原始文件数据的准确。

主要职责：
1. 熟练使用电子数据采集系统和电子病历系统；
2. 确保临床试验符合GCP和公司SOP，保证原始文件数据的准确、有效和可查询；
3. 将数据从原始文件录入到CRF或EDC中；
4. 完成纸质和电子版的CRF；
5. 审查患者数据以保证数据的完整和准确。

任职要求：
1. 医学相关专业本科以上学历；
2. 最好有2年以上CRA或数据管理经验；
3. 能准确高效地完成数据审查和CRF录入工作。

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