代维欧医药科技发展（上海）有限公司招聘临床研究助理（CRA）一名职务描述： – 遵循GCP法规要求，严格执行临床研究方案，对临床研究项目进行监查及报告– 确认临床研究过程中收集的试验数据的准确性、完整性和合理性并记录，确保临床研究项目CRF的完整性，保证其在公司与研究者之间的按时交接– 确保研究过程中所发生的所有不良事件按照研究要求进行报告– 确保试验药物计数、传递、贮藏及合理处方以及未使用药物的返回与销毁– 确保公司与研究基地之间通畅的联系和沟通，向部门经理及时书面报告项目进展– 临床项目监查报告起草及报告以及临床研究文件档案的管理– 与临床研究基地业务联系包括召集临床会议资质要求： – 医学或药学专业背景，学士学位以上，2年以上临床工作经验– 熟悉GCP法规要求，了解新药临床研究过程，具有SFDA颁发的CRA（培训）资格证书者优先– 工作认真仔细、能承受压力– 较强的团队合作精神、具有良好沟通能力、乐于与研究基地有关人员打交道– 英语六级水平及口语能力，熟练应用电脑办公软件Duties & Responsibilities: - To select/recommend potential investigational sites to CRA manager for a specific study, verify the qualification of the investigator and the suitability of the sites- To initiate and monitor clinical studies in compliance with study protocols, GCP guidelines, as well as company SOPs;- To document and archive all clinical trial relevant activities, verify the accuracy, completeness and accuracy of the data collected from the study site;- To ensure all case report forms (CRFs) are collected, quality checked and transferred from the investigators to the company in a timely manner;- To ensure all adverse events are reported in compliance with study requirements- To verify that trial medication is transferred, stored and dispensed appropriately and that unused drugs are returned or destroyed- To ensure a smooth communication throughout the studies between the company and site(s), report any studies related issues to the line manager in a timely mannerQualifications: - BS or higher degree with a background in medicine, pharmacy, pharmacokinetics, or pharmaceutical science; 2 years of experience in clinical research;- Good communication skills;- Good English skills, including literature reading, writing, and some verbal skills;- Willing to work at clinical sites and do some travel;- Meticulous and teamwork spirited.Contact info： contact@vivodevelopment.comTel: 021-5027-5347 x18Fax: 021-5027-5349