CRA Assistant
科文斯医药研发(北京)有限公司上海分公司
- 公司规模:500-1000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:2012-11-02
- 工作地点:上海
- 招聘人数:若干
- 工作经验:一年以上
- 学历要求:本科
- 职位类别:临床协调员
职位描述
Responsibility:
? Act as contact for project team and study sites
? Perform CRF review, query generation and resolution against established data review guidelines, under direct supervision on Covance or client data management systems, as assigned by management
? Assist with generation and reconciliation of queries to investigative sites/clients to resolve problem data
? Assist with the management of study supplies and organize shipments
? Create, update, track, and maintain study-specific trial management files, tools, and systems.
? Assist the local project team members with other administrative activities as required (e.g. payments to investigators, correspondence with clients, preparation of status reports, and organization of investigators' meetings)
? Co-ordinate meetings with clients, investigators, and project team, including taking minutes.
? Ensure compliance with Covance SOPs, FDA, ICH, and GCP regulations for clinical conduct in all aspects of daily work
? Provide input in writing Monitoring Conventions as assigned
? Assist in submissions and notifications to Ethics Committees and Regulatory Authorities
? General On-Site Monitoring Responsibilities:
o Assist Senior CRAs, CRA-2 and CRA-1 with on-site tasks as required and according to training goals (e.g. review of Case Report Forms and Study File Notebook, drug accountability)
o Initiate, monitor and close out clinical investigative sites under direct supervision from Clinical Research Associates 1 and 2, Sr. Clinical Research Associates, Project Managers or Project Directors
? Perform other duties as assigned by management
Requirements:
? University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology)
? In lieu of the above requirement, candidates with one (1) or more years of relevant clinical research experience in pharmaceutical or CRO industries may be considered
? Basic understanding of biology and biological processes
? Good organizational and time management skills
? Good communication skills, oral and written
? Exhibit general computer literacy
? Works efficiently and effectively in a matrix environment
? Fluent in local office language and in English, both written and verbal
? Act as contact for project team and study sites
? Perform CRF review, query generation and resolution against established data review guidelines, under direct supervision on Covance or client data management systems, as assigned by management
? Assist with generation and reconciliation of queries to investigative sites/clients to resolve problem data
? Assist with the management of study supplies and organize shipments
? Create, update, track, and maintain study-specific trial management files, tools, and systems.
? Assist the local project team members with other administrative activities as required (e.g. payments to investigators, correspondence with clients, preparation of status reports, and organization of investigators' meetings)
? Co-ordinate meetings with clients, investigators, and project team, including taking minutes.
? Ensure compliance with Covance SOPs, FDA, ICH, and GCP regulations for clinical conduct in all aspects of daily work
? Provide input in writing Monitoring Conventions as assigned
? Assist in submissions and notifications to Ethics Committees and Regulatory Authorities
? General On-Site Monitoring Responsibilities:
o Assist Senior CRAs, CRA-2 and CRA-1 with on-site tasks as required and according to training goals (e.g. review of Case Report Forms and Study File Notebook, drug accountability)
o Initiate, monitor and close out clinical investigative sites under direct supervision from Clinical Research Associates 1 and 2, Sr. Clinical Research Associates, Project Managers or Project Directors
? Perform other duties as assigned by management
Requirements:
? University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology)
? In lieu of the above requirement, candidates with one (1) or more years of relevant clinical research experience in pharmaceutical or CRO industries may be considered
? Basic understanding of biology and biological processes
? Good organizational and time management skills
? Good communication skills, oral and written
? Exhibit general computer literacy
? Works efficiently and effectively in a matrix environment
? Fluent in local office language and in English, both written and verbal
公司介绍
Covance is one of the world’s largest and most comprehensive drug development services companies with more than 10,000 employees in 60 countries. Through its nonclinical, clinical and commercialization services, Covance has helped pharmaceutical and biotech companies develop one-third of all prescription medicines in the market today.
Well come to our online job pool to dig out more opportunities at:
http://careers.covance.cn/
Well come to our online job pool to dig out more opportunities at:
http://careers.covance.cn/
联系方式
- 公司网站:http://www.covance.com
- Email:calvin.xu@covance.com
- 公司地址:上海市黄埔区西藏中路268号来福士广场1806室
- 邮政编码:200001
- 联系人:Vicky Qu