长沙招聘

职位描述：（工作方式：Home-based）
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。
要求：
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。
要求：
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 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;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;
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;
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;

北京赛德盛医药科技有限公司（简称赛德盛），公司由多名行业内资深人士创建，核心技术团队人员拥有数年多个国际多中心项目的操作及管理经验。管理团队人员熟悉ICH-GCP、SFDA-GCP的规范化操作要求，具有丰富的国内外临床研究执行及管理经验，拥有丰富的客户资源及行业专家资源，公司致力于国内临床研究事业的发展，立志成为中国临床研究领域最具影响力的公司之一。赛德盛秉承“尊重产品、尊重客户、尊重团队”的理念，为国内外的制药企业及生物制药公司提供全面优质的临床研究服务。
赛德盛的业务涵盖：CRO业务、SMO业务、培训、第三方独立稽查及人才服务五部分。