Job Title

Contract Duration: 6 monthsLocation: Toronto, ON(Hybrid)Essential FunctionsMonitors investigator sites with a risk-based monitoring approach: applies rootcause analysis (RCA), critical thinking and problem-solving skills to identify siteprocesses failure and corrective/preventive actions to bring the site intocompliance and decrease risks. Ensures data accuracy through SDR, SDV andCRF review as applicable through on-site and remote monitoring activities.Assess investigational product through physical inventory and records review.Documents observations in reports and letters in a timely manner usingapproved business writing standards. Escalates observed deficiencies and issuesto clinical management expeditiously and follow all issues through to resolution.May need to maintain regular contact between monitoring visits withinvestigative sites to confirm that the protocol is being followed, that previouslyidentified issues are being resolved and that the data is being recorded in atimely manner. Conducts monitoring tasks in accordance with the approvedmonitoring plan. Participates in the investigator payment process. Ensures ashared responsibility with other project team members on issues/findingsresolution. Investigates and follows-up on findings as applicable- Provides trial status tracking and progress update reports to the Clinical TeamManager (CTM) as required. Ensures study systems are updated per agreedstudy conventions (e.g. Clinical Trial Management System, CTMS). Performs QCcheck of reports generated from CTMS system where required.- Participates in investigator meetings as necessary. Identifies potentialinvestigators in collaboration with the client company to ensure the acceptabilityof qualified investigative sites. Initiates clinical trial sites according to therelevant procedures to ensure compliance with the protocol and regulatory andICH GCP obligations, making recommendations where warranted. Ensures trialclose out and retrieval of trial materials.- Ensures that required essential documents are complete and in place, accordingto ICH-GCP and applicable regulations. Conducts on-site file reviews as perproject specifications.