Charlotte Saxby

Profile

Charlotte has recently joined the Barts Cardiovascular Clinical Trials Unit (CV CTU) part-time to assist the Branch Manager and Clinical Trials Manager of the CV CTU, with support from the Barts CTU QA Lead, in ensuring and implementing the Quality Management System (QMS) for Clinical Trials run under the Barts CV CTU portfolio. The QA Officer will be responsible for the development, maintenance, implementation and oversight of a robust QMS for the CV CTU.

This will predominantly consist of conducting trial reviews including documentation reviews, monitoring and auditing CVCTU trials as necessary, as well as writing and reviewing Standard Operating Procedures (SOPs), managing and maintaining the Barts CV CTU training records and  oversight of the QMS applications in order to monitor staff training, and SOP reading and compliance.

Charlotte’s main roles and responsibilities are:

• Lead on QA activities within the CV CTU
• Implement and continue to develop and maintain a robust Quality Management System at CV CTU
• Conduct trial document reviews, monitoring and auditing of CVCTU trials
• Write and review SOPs, monitoring plans and other study documents when required
• Prepare or review CV CTU trial risk assessments in collaboration with the Chief Investigators and Unit Managers.
• Monitor staff SOP reading, compliance and training records through STASH
• Assist with the preparation for external audits and inspections
• Provide practical knowledge in the management of clinical trials with regards to ICH GCP, Research Governance Framework, Data Protection and applicable regulatory and statutory requirements.