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1年经验 -
本科 -
招若干人 -
11-09 发布
职位描述
职位描述： Responsibility: - To assist the site investigator to deliver high quality patient data in accordance with ICH/CFDA-GCP and as required by the SOPs and study protocol; - To participate in the recruitment and screening of research patients; - To be responsible for use of computer applications and other technology to enhance the efficiency of the workflow in study activities including data collection and query resolution; - To collect, prepare and submit of regulatory documents as per required by the site EC; - To attend site initiation meeting; - To prepare the documents for study monitor site visits; - To assist investigator in obtaining proper written consent from each study participant according to the requirement; - To perform functions necessary for completion of sponsor protocols including scheduling, patient enrollment, medical histories, clinical assessments, laboratory-phlebotomy and processing, diagnostic studies, dispensing of investigational medication and overall organization and logistics of study visits; - To complete and correct case report forms ensuring accuracy of all records connected with each research patients; - To assist the investigator to report and record all adverse events according to GCP Guidelines and the request of sponsor; - To maintain accurate record of all study supplies including lab kits, medications and other items dispensed to patients; - To maintain close contact with sponsor concerning patient enrollment, scheduling, dosing/dispensing, abnormal laboratory values and adverse events; - To ensure a smooth communication through the studies between the site investigator and Project team. Provide weekly timesheet to sponsor project team members; - To update the TMFs and ensure the accuracy and completeness of TMFs; - To perform other duties as required. Requirements: - Bachelor or above Degree in Medicine or Nursing is a MUST; - Familiar with hospital environment; - Excellent communication skills with doctors and patients; - Detailed orientated; - Organizational skills; - Ability to multi-task; - Can work under pressure; - Doctor or nurse who has oncology experience and is interested in clinical research is preferred. 职能类别： 内科医生 临床协调员 关键字： Clinical Study Coordinator, Study Nurse, Clinical Trial Coordinator
联系方式
莲花路1120号
公司信息
Chelsea Clinical Research is a Shanghai-based Contract Research Organization (CRO) which provides a comprehensive range of clinical trial services to international pharmaceutical companies, biotechnology companies and research institutions in China. Our mission is to deliver service excellence and timely, quality results for our clients. As a professional drug development organization, we believe in the value of building trusted parternership with our clients.
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