Trial Monitoring – Performance of pre-study, initiation, interim monitoring and close-out visits from phase I – IV for clinical sites located mainly in Canada. Assisting in Study start-up (site identification, elaboration of study tools/forms such as informed consent form, case report form template) and Study closure activities (database lock, facilitating safety committee’s meetings/review).

Site management/site support – Liaison between the Investigational sites (site management) or vendors (e.g., management of contracted Clinical research organizations) and the Sponsor. One-on-one assistance to the Investigator study team in various protocol-related activities (protocol/procedure training, case report forms entry, query resolution)

Project Management – Track clinical study performance to ensure on-time delivery, within scope and budget. Proactively organizing and tracking all study activities, milestones, and metrics using Clinical Trial Management Systems (CTMS).

Study Coordination – Patient recruitment (identifies and screens potential subjects); plan, implement, review and coordinate all aspects of data collection and source documentation. Coordinate patient visits and schedule as per study protocol. Research ethics board submissions, and other administrative project management administrative tasks.