Mrs Kelly Gee
Head of Quality Assurance and Regulatory Affairs
I am currently the Head of Quality Assurance and Regulatory Affairs at the Centre for Trial research in this role I lead on the application and interpretation of Regulations in the UK and abroad. Liase with regulators, sponsors and other CTU's to establish and drive forward best practice.
My previous post was as the Regulatory Affairs Manager at the centre for Trials Research. This role involves delivering for the Centre high quality Regulatory Affairs (RA) work including Pharmacovigilance & Safety (PV & S).Providing advice, guidance, training and support, and developing and leading on projects within this area. I have also worked as a Specialist in Pharmacovigilance and Safety within the Centre for Trials Research. This role involved being responsible for providing advice, guidance and support and leading on projects within the area of pharmacovigilance and safety reporting. This is to ensure the Centre meets regulatory expectations and ensures best practice as well as safeguarding patient safety in the clinical trials and studies that we run.
I have over 11 years experience in clinical trials and have worked in an R&D Department of a mid sized NHS Trust as well as a variety of other research roles.