Senior CRA
精鼎医药研究开发(上海)有限公司
- 公司规模:10000人以上
- 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:2012-11-13
- 工作地点:广州
- 招聘人数:若干
- 工作经验:三年以上
- 学历要求:本科
- 语言要求:英语熟练
- 职位类别:临床研究员 药品注册
职位描述
Job Description:
1.To perform clinical monitoring activities of designated projects in accordance with the APEX SOPs (or the Sponsor’s SOPs as appropriate), which include: investigator/site selection, managing and co-ordinating site related activities, collating regulatory documentation and IRB submissions, and monitoring activities (such as source data verification, drug accountability, etc.) throughout the study in accordance with the ICH GCP guidelines.
2.Also accountable for detecting, analyzing and solving technical, procedural and/or motivational problems that may occur to the site staff of the investigation team and thus affect the progress of the project.
3.At priority to be designated as a mentor for other CRAs.
Requirement and Qualification:
1.A bachelor (or above) degree in a life science (preferably paramedical) field.
2.More than 3 years’ work experience in clinical operations, particularly study monitoring.
3.Good communication skill and proactive attitude.
4.Ability to take initiative and work independently.
5.Ability to speak and read the language(s) used locally in the country, plus a fluency in written and spoken English.
6.Ability to manage multiple and varied tasks, and prioritize workload with attention to details.
7.Ability to travel – on both local and international trips.
1.To perform clinical monitoring activities of designated projects in accordance with the APEX SOPs (or the Sponsor’s SOPs as appropriate), which include: investigator/site selection, managing and co-ordinating site related activities, collating regulatory documentation and IRB submissions, and monitoring activities (such as source data verification, drug accountability, etc.) throughout the study in accordance with the ICH GCP guidelines.
2.Also accountable for detecting, analyzing and solving technical, procedural and/or motivational problems that may occur to the site staff of the investigation team and thus affect the progress of the project.
3.At priority to be designated as a mentor for other CRAs.
Requirement and Qualification:
1.A bachelor (or above) degree in a life science (preferably paramedical) field.
2.More than 3 years’ work experience in clinical operations, particularly study monitoring.
3.Good communication skill and proactive attitude.
4.Ability to take initiative and work independently.
5.Ability to speak and read the language(s) used locally in the country, plus a fluency in written and spoken English.
6.Ability to manage multiple and varied tasks, and prioritize workload with attention to details.
7.Ability to travel – on both local and international trips.
公司介绍
精鼎医药(Parexel International)是全球领先的药物研究合同委托机构(CRO),总部位于美国生物医药圣地马萨诸塞州的波士顿附近,在世界各地拥有71个办事处,约17,600 名员工,为超过100个国家的客户提供服务。
精鼎医药成立于1982年,在三十多年的历程中,一直致力于发展成为全球生物制药和医疗器械行业首屈一指的新型医学疗法开发和商业化服务供应商,并且取得了卓越成果。目前,我们能够提供全世界CRO领域全面的新药临床阶段研发服务,服务内容包括新药开发策略的拟定与计划、国际临床试验规划执行及整合、临床试验的监测、临床试验数据处理、临床研究统计分析、临床试验总结及统计报告、临床试验稽核服务、临床试验供应和物流服务、临床电子数据采集、临床医学信息管理系统、新药查验登记事务和国际临床试验相关法规咨询等。
将我们的全球法规监管专业经验、I-IV期临床研究服务、整合的电子化临床技术能力和商业化服务结合在一起的一体化解决方案,可帮助我们的客户更加顺畅、经济和高效的推动整个研发历程。
精鼎医药成立于1982年,在三十多年的历程中,一直致力于发展成为全球生物制药和医疗器械行业首屈一指的新型医学疗法开发和商业化服务供应商,并且取得了卓越成果。目前,我们能够提供全世界CRO领域全面的新药临床阶段研发服务,服务内容包括新药开发策略的拟定与计划、国际临床试验规划执行及整合、临床试验的监测、临床试验数据处理、临床研究统计分析、临床试验总结及统计报告、临床试验稽核服务、临床试验供应和物流服务、临床电子数据采集、临床医学信息管理系统、新药查验登记事务和国际临床试验相关法规咨询等。
将我们的全球法规监管专业经验、I-IV期临床研究服务、整合的电子化临床技术能力和商业化服务结合在一起的一体化解决方案,可帮助我们的客户更加顺畅、经济和高效的推动整个研发历程。
联系方式
- Email:tony.feng@parexel.com
- 公司地址:上海市浦东新区商城路506号新梅联合广场B座9层 (邮编:200120)