หน้าที่ความรับผิดชอบ

- Creating and writing trial protocols, and presenting these to steering committee
- Design data collection forms, known as case report forms (CRFs) and/or relevant documents as assigned
- Initiate and revise standard operating procedures including the instruction if required
- Coordinate with the ethics committee, which safeguards the rights, safety and wellbeing of all trial subjects
- Manage regulatory authority applications and approvals
- Identify and assess the suitability of facilities to use as the clinical trial site
- Identify/select an investigator who will be responsible for conducting the trial at the trial site
liaise with doctors, consultants or investigators on conducting the trial
- Set up the trial sites – ensure, reconcile and record whether each center has the trial materials, including the trial drug often known as the investigational medicinal product (IMP)
- Train the site staffs to trial-specific industry standards
- Monitor the trial throughout its duration, which involves visiting the trial sites on a regular basis, coordinating project meetings and writing visit reports
- Verify that data entered on to the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV)
- Attention to detail including ability to work as a team or independently if required
- Close down trial sites on completion of the trial and prepare final reports and occasionally manuscripts for publication
- Archive study documentation and correspondence
Implementing action plans for sites not meeting expectations including report to the management