[北京]上海切尔西医药科技咨询有限公司

- To assist the site investigator to deliver high quality patient data in accordance with ICH/SFDA-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 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.