• Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. • Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. • Documents observations in reports and letters in a timely manner using approved business writing standards. • Conducts monitoring tasks in accordance with the approved monitoring plan. • Participates in the investigator payment process. • Ensures a shared responsibility with other project team members on issues/findings resolution. • Investigates and follows-up on findings as applicable. • Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. • Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System, CTMS). • Performs QC check of reports generated from CTMS system where required. • Participates in investigator meetings as necessary. • Insures trial close out and retrieval of trial materials. • Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. • Conducts on-site file reviews as per project specifications. • Contributes to the project team by assisting in preparation of project publications/tools and sharing ideas/suggestions with team members.