Matthew Turner Email & Phone Number

Nashville, Tn, Us

Bridging the gap between CRO and site.

Operational oversight of Site Startup and Clinical Project Administration

Greater Nashville Area, Tn

• Manages performance and professional development of Site Support staff.• Develops status reports based on department metrics and communicate to leadership.• Provides site level regulatory support to the TN Oncology site and internal departmentleaders in relation to the status of start-up and ongoing regulatory maintenance• Works closely with department directors and/or principal investigators• Optimizes processes to ensure both efficiency and quality• Establishes and maintains a document management system for regulatory paper andelectronic files for each study at the site• Maintains updated physician credentials for TN Oncology site and other criticaldocumentation ensuring compliance• Maintains study specific DOA log• Meets with monitors and auditors to review regulatory binder• Resolves key monitor issues with Pharmaceutical Industry Partners and GovernmentAgencies• Provides response to regulatory items on monitor follow up letter• Tracks documents pending site regulatory signatures• Posts and permissions protocol documents• Routes and tracks completion of protocol training• Maintains FDA and GCP required regulatory documentation for individual sites, studies,sponsors and/or other networks.• Establishes, enforces and executes policies that ensure site level documentation andbinders are compliant with all applicable laws, regulations, SOPs and other applicableguidelines.• Triages site requests for regulatory support and identifies correct pathway for issueresolution• Communicates and escalates unresolved issues at the appropriate time and to theappropriate level of leadership.• Ensures all staff adheres to professional standards, Good Clinical Practice (GCP) and SOPsestablished for clinical research

- Provide site level regulatory support to the TN Oncology site and internal department managers in relation to the status of start-up and ongoing regulatory maintenance - Maintain FDA and GCP required regulatory documentation for individual sites, studies, sponsors and/or other networks. Ensure all regulatory documentation is compliant with local Standard Operating Procedures (SOP’s) for format and content- Maintain Delegation of Authority and 1572 logs for studies.- Route new and amendment protocol training for all staff. - Post and permission protocol documents- Maintain investigator credentials including GCP training, Medical License, and CV- Monitor, coordinate and assist process consistency and communications across the Site Services’ departments as required- Assist with the editing of Standard Operating Procedures (SOPs) and/or Work Instructions (WIs) within Site Services- Perform related work as required- All other duties as assigned

-Participated in validation of a new test to predict presence of high grade prostate cancer.-Processed all incoming specimen for medical testing and research.-Ensured all PHI was kept confidential in accordance to HIPPA guidelines.-Worked closely with billing, client services, compliance, and IT departments.