CRA intern-杭州(2021校招)
杭州泰格医药科技股份有限公司
- 公司规模:5000-10000人
- 公司性质:合资(非欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2020-10-26
- 工作地点:杭州
- 招聘人数:6人
- 工作经验:在校生/应届生
- 学历要求:本科
- 语言要求:英语良好
- 职位月薪:2-3千/月
- 职位类别:临床研究员 实习生
职位描述
岗位要求:
1、临床医学、临床药学、预防医学、药学、护理学等相关专业本科及以上学历;
2、CET6,读写流利;
3、有志于在临床试验行业发展,工作表现优秀有留用机会;
4、此职位面向2020年毕业生,希望每周实习3天以上,持续3个月以上。
Responsibilities
(1) Monitoring
Monitoring
- Perform pre-study visit to ensure the site has adequate resources for the study.
- Ensure Principal Investigator/study staff complies with safety reporting requirements, as defined
in protocol, SOP and ICH-GCP.
- Track study recruitment to ensure recruitment target is achieved in all studies.
- Conduct monitoring visit according to SDV plan and SOP; address issues with sites and complete
monitoring visit report in a timely manner Coordinating
- Ensure timely coordination of study materials (drug, non-drug, equipments, CRFs) to the site for
start-up and throughout the study.
- Assemble site specific EC submission dossier, and ensure submission to EC.
Training
- Provide ongoing training to site staff with regards to ICH-GCP, study protocol and requirements.
- Conduct site initiation to ensure that the site has a thorough understanding of the study protocol
and requirements.
Documentation
- Collect essential documents at study start-up, during and at study close-down. Maintain and
update these documents in investigator files, trial master files.
- Prepare/Pack for archiving at the end of the study.
(2) Drug Safety
- Ensure safety information is disseminated to all sites according SOP and applicable regulations.
- Report SAE promptly according to SOPs and applicable regulations.
(3) Finance and Administration
- Finalize budget and obtain signed contract from site, prior to site initiation visit.
- Ensure Study Payment Schedule is executed and retain relevant documents/receipts.
(4) Study Tools and system
- Update and maintain Study tools/systems in a timely manner.
Qualifications
Bachelor degree in biomedical/science discipline or equivalent (e.g. medical, Nurse , Pharmacology)
Good understanding and knowledge of Good Clinical Practice and clinical trial operation processes/
procedures
Good working and proactive attitude
Value importance of teamwork
Good command of written and verbal English
公司介绍
联系方式
- Email:TA@tigermedgrp.com
- 公司地址:杭州市滨江区聚工路19号盛大科技园
- 电话:18815130591