Clinical Research Associate
辉凌医药咨询（上海）有限公司
- 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：2017-01-10
- 工作地点：北京-东城区
- 招聘人数：1
- 工作经验：二年以上
- 学历要求：本科
- 语言要求：英语熟练
- 职位类别：临床协调员
职位描述
Responsibilities:
1.Assist Clinical Trial Manager with the identification and selection of study sites to undertake clinical studies, when required.
2.Assist Clinical Trial Manager with preparation of clinical trial plan.
3.Assist Clinical Trial Manager with preparing of Advisory Board Meeting and Investigator Meeting.
4.Prepare documentation for Ethics Committee submission.
5.Coordinate receipt and distribution of clinical trial supplies.
6.To be responsible for initialing, monitoring and closing the clinical study sites and ensure that the clinical trial progress according to quality standards, Ferring's SOPs, ICH-GCP and/or other guidelines to fulfill local regulations.
7.Liaise with and report to Clinical Trial Manager regularly on study status through monitoring reports and meetings.
8.Perform Source Data Verification to ensure accurate data is recorded.
9.Ensure all Serious Adverse Events are reported and followed up according to Ferring SOPs.
10.Ensure the storage and issue of clinical drug supplies are strictly according to the protocol.
11.Maintain drug accountability of all clinical supplies and arrange for destruction as per specified clinical study.
12.Coordinate the resolution of data queries and their return to Ferring in a timely manner.
13.Maintain appropriately and safely all necessary documents in Trial Master Files.
14.Track study payments to ensure payments are on time and within the budget.
15.To build and keep good working relationship with the clinical study sites.
Qualifications:
1.Bachelor's degree or above in Medical, Pharmacy or related areas.
2.Fluent English (oral and written).
3.At least two year experience in clinical trial execution.
4.With a reliable, responsible, diligent and positive working attitude.
5.Excellent in communication skills and is expected to establish good relationship with the Investigators and other related site personnel.
6.Should expect to work under strong pressure and to travel frequently.
7.Self-motivated for success
8.Good professional image
9.Effective operation both independently and as a team member.
1.Assist Clinical Trial Manager with the identification and selection of study sites to undertake clinical studies, when required.
2.Assist Clinical Trial Manager with preparation of clinical trial plan.
3.Assist Clinical Trial Manager with preparing of Advisory Board Meeting and Investigator Meeting.
4.Prepare documentation for Ethics Committee submission.
5.Coordinate receipt and distribution of clinical trial supplies.
6.To be responsible for initialing, monitoring and closing the clinical study sites and ensure that the clinical trial progress according to quality standards, Ferring's SOPs, ICH-GCP and/or other guidelines to fulfill local regulations.
7.Liaise with and report to Clinical Trial Manager regularly on study status through monitoring reports and meetings.
8.Perform Source Data Verification to ensure accurate data is recorded.
9.Ensure all Serious Adverse Events are reported and followed up according to Ferring SOPs.
10.Ensure the storage and issue of clinical drug supplies are strictly according to the protocol.
11.Maintain drug accountability of all clinical supplies and arrange for destruction as per specified clinical study.
12.Coordinate the resolution of data queries and their return to Ferring in a timely manner.
13.Maintain appropriately and safely all necessary documents in Trial Master Files.
14.Track study payments to ensure payments are on time and within the budget.
15.To build and keep good working relationship with the clinical study sites.
Qualifications:
1.Bachelor's degree or above in Medical, Pharmacy or related areas.
2.Fluent English (oral and written).
3.At least two year experience in clinical trial execution.
4.With a reliable, responsible, diligent and positive working attitude.
5.Excellent in communication skills and is expected to establish good relationship with the Investigators and other related site personnel.
6.Should expect to work under strong pressure and to travel frequently.
7.Self-motivated for success
8.Good professional image
9.Effective operation both independently and as a team member.
公司介绍
辉凌医药咨询（上海）有限公司诚聘
联系方式
- 公司地址：杭州市