月薪60000元 台北市信義區 3年工作經驗 今天剛更新
1. To coordinate and communicate with sponsor, investigators, external vendor, and internal operations to ensure the smooth running of clinical trial.
2. To supervise and manage the clinical trial for site selection & identification activities, Ethics committee approval, development of recruitment strategies to increase patient enrollment, and the provision of clinical trial materials.
3. To ensure that all aspects of GCP are complied with at all times through provision of training at start-up, initiation meetings for clinical trials.
4. To ensure the monitoring of clinical trials by identifying and managing qualified staff, establishing quality control procedures and ensuring that cleaned data is entered into the database in a timely fashion.
5. To participate on corporate clinical research teams ensuring that colleagues are updated on all relevant issues and documents into the central files.
6. To ensure the smooth running by developing systems to track projects including all study, investigator and ethical review board information, patient recruitment activity and financial management.
7. To be responsible for reporting project status, issues, progress, and budget to internal/external parties.
8. To assist and/or be responsible for preparation of inspection and/or audit and responses of CAPA.
9. To implement and/or arrange training programs per project specific tasks for project team that include: principles and practices of project management, team communication, computer software and IT training, adverse event reporting and the importance of pharmacovigilance, and budget control and reporting.
10. To complete tasks as requested.
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