As part of the site visits, independently conducts Informed Consent (ICF) review, source data verification/source document review, review for compliance with required reporting/tracking of adverse events and protocol deviations, investigator site file review, laboratory tour and specimen storage assessment, pharmacy/Investigational Product (IP)/Investigational Device (ID) storage location tour and storage condition assessment, IP/ID accountability, facilities tours, and other activities per the site monitoring plan under minimal direction from the project CRA staff oversight lead. Responsibilities: Under minimal supervision of the project CRA staff oversight lead (i.e. Clinical Study Manager, Lead CRA, Project Manager, etc.) independently schedules and conducts remote and on site monitoring visits such as qualification/pre study visits, site initiation visits, interim/routine monitoring visits, closeout visits, and for cause visits.