Responsibilities:
1. Managing regulatory authority/IRB applications and approvals.
2. Coordinates and executes clinical research activities for assigned trials and
supports the evaluation of new trials.
3. Provides technical input to study protocols and assigned studies through all
stages of the study process.
4. Train and manages study sites and conduct/document study per protocol
using GCP guidelines and SOPs.
5. Preparation of clinical trial budget and tracking of expenditure.
6. Conduct qualification, initiation, monitoring, and closeout visits for research
sites in compliance with the approved protocol.
7. Communication with the site staff, including investigators, coordinators, and
other site staffs.