Tiago Aguiar Email and Phone Number

Assist the Principal Investigator in the proper conduct of the study. · Conduct quality of life questionnaires to subjects. · Perform data entry, resolve queries and report adverse events/serious adverse events in eCRF. · Dispense the IP or IP/placebo and manage Data Correction Reports in IRT· Responsible for maintaining the Investigator's File. · Organization of meeting with clinical study team in the site, CRA and vendors. · Coordinate Site Initiation Visits, Monitoring Visits and Close Out Visits in the site in accordance to GCP. · Support the collection and archiving of essential documents in accordance to GCP. · Support the preparation and submission of regulatory and ethical documents, such as protocol deviations, partial and final reports, serious adverse event reports, initial submission of the protocol and amendments.