Project Manager
CurrentProject Management- Manage research activities for project, including study start-up, active phase, analysis, and closeout; ensuring compliance with study protocol and regulatory requirements- Central contact for project, including study Principal Investigator, clinicians, coordinators, funding agencies, stakeholders- Maintain appropriate regulatory documents and correspondence for sites/personnel- Provide training and ongoing support to all participating sitesMonitoring- Conduct monitoring visits to ensure site compliance and adherence to study protocol and applicable regulatory guidelines (Health Canada, FDA, ICH-GCP, etc) both remotely and on-site as required- Create and distribute data monitoring reports and action item lists to site staff post visit and follow up with site investigator until completionData Management- Responsible for data management (logging, tracking in database, entry, verification, reporting of data, ensuring protocol compliance)- Directly involved in site communication regarding data management (queries, overdue data entry, requesting supporting documents, providing site support for data related inquiries)- Manage adverse event reporting, including expedited reporting to Health Canada for all Serious and Unexpected Adverse Drug Reaction (SUADRs)