Monitoring:

•      At-site traditional monitoring (including source data review and source data verification, drug accountability, regulatory document reconciliation...).  The at-site monitoring is available for sites predominately in upstate New York (Buffalo, Rochester, Syracuse, Albany, and south to Binghampton and Johnson City) but also within a five-hour driving radius of Syracuse, NY, including Cleveland, Vermont and New Hampshire. 

•      Remote SDR and SDV

•      Site start-up activities (site qualification visit, regulatory document collection, contract and budget negotiation, IRB approval...)

Clinical Trial Management/Lead CRA:

• Study start-up tasks ( to include creating the clinical monitoring plan and associated monitoring visit guidance documents, SIV slide deck, monitoring tool creation...)

• Site startup activities

• Monitoring visit report review

• Vendor and CTMS reports generation for managers and CRA

• CRA training and supervision