Clinical Trial Assistant
和铂医药(上海)有限责任公司
- 公司规模:150-500人
- 公司性质:外资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2019-09-27
- 工作地点:上海-徐汇区
- 招聘人数:2人
- 工作经验:无工作经验
- 学历要求:招2人
- 语言要求:不限
- 职位月薪:0.8-1万/月
- 职位类别:临床协调员
职位描述
Job Description
1. Coordinates the collection and entry of project tracking including but not limited to the following essential documents, patient data, site visit dates, protocol deviations, and trip reports into tracking systems.
2. Provides logistic and administrative support to project teams.
3. Communicates project status to the project team as appropriate.
4. Scans and copies project documentation inclusive of, but not limited to, essential documents, CRFs, and DCFs.
5. Copies, collates and produces study binders.
6. Reviews deliverable to ensure accuracy of content and materials copied.
7. Supports the project team in preparation of documentation for Regulatory and Ethical Submissions.
8. Organizes study documents and materials in compliance with Project SOPs regarding regulatory documentation as appropriate.
9. Archives project related documentation.
10. Reports all document collection and tracking issues to project team on a regular basis
11. Establishes and maintains QC of the Trial Master File in accordance with project, organizational and regulatory requirements.
Requirement:
1. College and above graduate, preferably with a healthcare or life science degree
2. Good knowledge of ICH-GCP, GCP and local clinical trial regulations
3. Basic computer skill (MS Office, Internet, etc)
4. Ability to work independently and as part of a team
5. Self-initiative to perform duties, with good analytical and problem-solving capabilities Ability to handle multiple tasks and expected to follow through with completion of assigned tasks with minimal supervision
6. More than 1 year experience of clinical trial assistant is a plus
7. English: Good at speaking, writing
公司介绍
Company Overview
Harbour BioMed is a global biotechnology company discovering and developing innovative therapeutics for cancer with a focus on immuno-oncology and autoimmunity/inflammation. The company's discovery and development programs are centered around its two patented transgenic mouse platforms for human antibody discovery.
The company is building its proprietary pipeline internally, through collaborations with co-development partners, as well as through selective preclinical and clinical stage asset acquisitions. Harbour BioMed also licenses the platforms to companies and academic institutions through its Harbour Antibodies subsidiary.
Harbour BioMed has headquarters and an R&D site in Shanghai, business operations in Cambridge, MA, and antibody platform development in Rotterdam, The Netherlands.
The company has an innovation center including research lab and a development team in Boston. Also, we are expanding to Kunshan site in Jiangsu for our R&D operation.
联系方式
- Email:joyce.xia@harbourbiomed.com
- 公司地址:地址:span北京市建国路118号招商局大厦2楼A01室