Syneos Health™ is the only fully integrated biopharmaceutical solutions organization. Our company, including a Contract Research Organization (CRO) and Contract Commercial Organization (CCO), is purpose-built to accelerate customer performance to address modern market realities. Created through the merger of two industry leading companies — INC Research and inVentiv Health — we bring together more than 21,000 clinical and commercial minds with the ability to support customers in more than 110 countries. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. In short, we are shortening the distance from lab to life.

Perform the following (including but not limited to):•Perform feasibility studies for potential sites as requested•Conduct pre-study visits in adherence to the protocol requirements•Assist in conduct of on-site interim monitoring visits in adherence to the protocol requirements•Compile and ensure completeness of regulatory documents and ethical submission documentation as appropriate and required (e.g. IRB / IEC study approval, informed consent, etc.)•Coordinate study material (e.g. CRFs, manuals) shipment and receipt by study site•Document site visit findings via written reports•Assess, monitor, and train study site staff on protocol adherence as required•Review study subject safety information and informed consent•Conduct source document verification for compliance, patient safety, and veracity of data•Review CRFs using paper or electronic data capture systems•Assist the site in maintenance of the Investigator Site File•Maintain regular communication with sites•Provide applicable updates for site related documentation for filing in the Trial Master File (TMF)•Assist sites in data query resolution•Ensure site compliance with IP receipt, accountability and return or destruction

Perform the following (including but not limited to):•Perform feasibility studies for potential sites as requested•Conduct pre-study visits in adherence to the protocol requirements•Assist in conduct of on-site interim monitoring visits in adherence to the protocol requirements•Compile and ensure completeness of regulatory documents and ethical submission documentation as appropriate and required (e.g. IRB/IEC study approval, informed consents, etc.)•Coordinate study material (e.g. CRFs, manuals) shipment and receipt by sites•Assess, monitor, and train study staff on protocol adherence as required•Review study subject safety information and informed consent•Conduct source data verification for compliance and veracity of data•Review CRFs using paper or electronic data capture systems•Assist the site in maintenance of the Investigator Site File•Maintain regular communication with sites•Provide applicable updates for site related documentation for filling in the Trial Master File (TMF)•Assist sites in data query resolution•Ensure site compliance with IP receipt, accountability and return or destruction