[北京]默沙东（中国）投资有限公司

职位：Site Executive,GCTO（CRA）（北京）
发布时间：2024-09-19
工作地点：北京
信息来源：前程无忧(51JOB)
职位类型：全职
职位描述
职能类别:临床监查员
- Position Overview
· Acts as primary site contact and site manager for all operational and routine protocol issues in support of clinical research studies. Communicates with sites on issues related to protocol conduct, enrollment/retention, protocol deviations, regulatory documentation, site audits/inspections, overall site performance, and financial payments.
· Performs on-site monitoring visits, ensuring site compliance with protocol, ICH, GCP global standards, local laws and regulations, including but not limited to review of informed consent, AE/SAEs, Health Authority documentation, and IMP supplies. Performs source document verification of subject data and query resolution. Coordinate receipt and distribution of clinical trial supplies.
· Provides input to Site Selection utilizing site evaluation and validation processes.
· Maintains accurate study site information in the CTMS and records visit and non-visit contacts appropriately and in a timely manner. Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
· Manages a full complement of sites with multiple protocols, depending on study/site complexity. Discusses the need for escalation of site performance issues with CRM, and supports audit/inspection activities as needed.

- Requirements
· Medical qualifications, bachelor＇s degree or above in Clinical Medicine, Pharmacology and Public Health, etc., strong emphasis in science.
· Work with high quality and compliance mind-set.
· Proficiency in computer skills.
· Result oriented.
· Teamwork spirit and cooperation skills.
· Customer focus.
· Good communication skill.
· Proactive and self-motivated. 公司简要介绍：
公司名称:默沙东（中国）投资有限公司
公司类型:外资（欧美）
公司介绍:在默沙东（默沙东是美国新泽西州罗威市默克公司的公司商号），我们齐心协力追求共同的目标：我们发挥前沿科学的力量，在全球范围内拯救生命、改善生活。一个多世纪以来，我们始终处于研发前线，为攻克全球最为棘手的疾病带来药物、疫苗和创新的健康解决方案。