Clinical Research Associate Trainee 临床试验监查员培训生(上海) (职位编号:091902)
百济神州(北京)生物科技有限公司
- 公司规模:5000-10000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:2020-12-27
- 工作地点:上海
- 招聘人数:若干人
- 工作经验:本科
- 学历要求:招若干人
- 语言要求:不限
- 职位类别:大学/大专应届毕业生
职位描述
Major Responsibilities:
1. Complete Clinical Research Associate Talent Program, appropriate therapeutic, protocol training
2. Gain experience in clinical research practical procedures by working with experienced clinical staff
3. Work closely with assigned mentors to perform observational visits (including pre-study, initiation, monitoring and close out visits etc.) in accordance with SOPs, China GCP and ICH-GCP
4. Collaborate and liaise with study team members for project execution support as appropriate.
5. Under close supervision, assess the proper conduct of the protocol and adherence of applicable regulations at the observed site.
6. Under close supervision, evaluate the quality and integrity of practices and process at the observed site.
7. Under close supervision, conduct co-monitoring visits if required. Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting visit reports, generating follow-up letters and other required study documentation.
8. Manage the progress of assigned studies by tracking applicable milestones (regulatory/EC submissions, approvals, recruitment and enrollment, Case Report Form (CRF) completion and submission, and data query generation and resolution etc.). Under close supervision support start-up phase.
9. Collaborates with CTAs, PMAs, CRAs, COMs to achieve the study milestones as needed
10. Performs additional task as assigned
Qualification:
1. Bachelor’s degree or above in life sciences, health care or equivalent combination of education, training and experience Required knowledge and skills
2. Good communication and interpersonal skills
3. Good organizational and effective time management skills
4. Good problem-solving skills
5. Good command in verbal and written English
职能类别:大学/大专应届毕业生
公司介绍
联系方式
- Email:shan.liu@beigene.com
- 公司地址:昌平区生命科学园 (邮编:102206)