Responsibilities include, however not limited to:

• Act as the primary site contact and site manager for allocated clinical research sites
• Develop and maintain strong site relationships throughout all phases of the trial
• Perform site management and monitoring activities in compliance with ICH-GCP, sponsor procedures, local laws and regulations, protocol requirements, site monitoring plans, and related documents
• Develop an in-depth understanding of the study protocol and associated procedures
• Coordinate and manage site readiness activities in collaboration with other sponsor functions
• Participate in site selection and site validation activities
• Conduct remote and on-site monitoring and oversight activities to ensure data integrity and subject safety
• Conduct site visits including validation visits, initiation visits, monitoring visits, and close-out visits
• Prepare clear, comprehensive, and timely visit reports and non-visit contact reports
• Collect, review, and monitor regulatory documentation for study start-up, maintenance, and close-out
• Communicate with investigators and site staff regarding protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, audits, inspections, and site performance
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