Clinical Project Management, Site Management, Study Monitoring & Team Monitoring
Perform routine site visits, including Pre-study, Initiation, Observation, Interim, and Closeout visits as well as Co-monitoring visits
Serve as Project Manager & sometime back up, Project Clinical Monitoring Group when required.
Vendor Management like CRO, SMO/SSO, DM, Central Lab, eCRF consultant, Insurance consultant and Instrument & Calibration consultant.
Provide training to team & colleagues on clinical, regulatory, administrative, company procedures and processes.
Participate in feasibility studies.
Assist with company’s quality control initiative.
Present study materials at Investigator/study l.