Clinical Research Associate II

Performs and coordinates all aspects of the clinical site monitoring services, assessing for protocol and regulatory compliance. Responsibilities include driving investigative site and patient recruitment, conducting source data verification, assessing drug accountability, data collection, (regulatory) document collection, performing qualification, initiation, monitoring and close out visits at investigational sites in accordance with corporate, sponsor and regulatory (ICH GCP and other) standards and guidelines. Represents the corporation by maintaining collaborative relationships with stakeholders. Conducts and documents site initiation, routine monitoring and close out visits, reviewing files, forms, and filings to ensure alignment with SOPs, study guidelines and GCP best practices. Work with site staff to verify CRF data are consistent with patient clinical source documents. Monitor, resolve and/or facilitate resolution of queries arising out of regular and/or safety reviews, adverse events, and other data management activities throughout the trial. Conduct remote visits as requested or as needed. Assess and manage Investigational Product supply including supply, accountability, and destruction/return status. Ensures site staff is trained on all aspects of the study.