所属行业：生物/制药/保健/医药/医学
公司性质：内资CRO / 成立日期：2010-11-30 / 注册资金：500万元 / 公司规模：50-200人
所在地区：北京*北京市*朝阳区 / 经营品牌：
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发布时间：2013-09-24 09:12:34
| 招聘类别：全职 | 招聘部门：无 | 招聘人数：若干人 | 薪资待遇：面议 |
| 工作经验：2年以上 | 学历要求：大专 | 性别要求：不限 | 年龄要求：不限 |
| 专业要求：医学 | |||
| 工作地点：湖北省武汉市 | |||
1.医学或相关专业本科以上学历
2.熟悉GCP及相关法律法规
3.良好的沟通能力及团队合作精神
4.适应出差，在压力下工作。
Key Res职位描述：
1.根据GCP及公司SOP执行临床监查工作。
2.确保试验严格按照方案，GCP及相关法律法规执行。
3.协调研究中心解决试验过程中可能出现的问题。
4.确保研究数据及时，准确。完整的记录在病例报告表中。
5.及时全面的向项目经理汇报研究中心进展情况。
6.协调研究者及时完成数据疑问。
7.及时完整地收集研究相关资料。
-Bachelor degree or above, at clinical medicine or related;
-Knowledge of S/FDA regulatory requirements and ICH/GCP guidelines essential;
-One year’s experience in clinical operations;
-Good communication skills, and attention at details, information analyzing;
-Good team spirits;
-Ability to work under pressure and travel;ponsibilities:
-To conduct clinical monitoring activities in accordance with SOPs, S/FDA regulations, and ICH/GCP guidelines, including site selection, IRB submission, and routine monitoring activities (such as source data verification, investigational products and other supplies management.);
-To report study status through monitoring report and meeting;
-To Assist Project Manager with preparation of study payment;
-To identify, analyze and resolve (assist with Project Manager) issues may occur at site;
-To maintain Trial Master File as required;
-Bachelor degree or above, at clinical medicine or related;
-Knowledge of S/FDA regulatory requirements and ICH/GCP guidelines essential;
-One year’s experience in clinical operations;
-Good communication skills, and attention at details, information analyzing;
-Good team spirits;
-Ability to work under pressure and travel;
Key Responsibilities:
-To conduct clinical monitoring activities in accordance with SOPs, S/FDA regulations, and ICH/GCP guidelines, including site selection, IRB submission, and routine monitoring activities (such as source data verification, investigational products and other supplies management.);
-To report study status through monitoring report and meeting;
-To Assist Project Manager with preparation of study payment;
-To identify, analyze and resolve (assist with Project Manager) issues may occur at site;
-To maintain Trial Master File as required;
Requirements:
-Bachelor degree or above, at clinical medicine or related;
-Knowledge of S/FDA regulatory requirements and ICH/GCP guidelines essential;
-One year’s experience in clinical operations;
-Good communication skills, and attention at details, information analyzing;
-Good team spirits;
-Ability to work under pressure and travel;
该职位招聘已结束！
