Senior Study Administrator
Michelle is a Senior Study Administrator within the Clinical Trials Services Unit (CTSU). Since joining the unit, she has worked on multiple international large-scale randomised clinical trials.
Currently, Michelle provides support to the RECOVERY trial data linkage team. This includes managing the process of establishing access to data through to completion of data access requests.
She also manages applications to national NHS data custodians, national registries and regulatory authorities (e.g. NHS Digital & the Confidentiality Advisory Group (CAG)) for legacy trials conducting long-term follow-up. This includes supplementary activities relating to data applications (e.g. applications to Research Ethics Committees (REC), the Confidentiality Advisory Group (CAG), preparation of Privacy Notices, Data Protection Impact Assessments (DPIA), and completion of Annual Reviews).
Michelle has responsibility for unit-wide clinical trial registrations, updates and results reporting (e.g. ClinicalTrials.gov and the ISRCTN).
Past responsibilities included working on the REVEAL trial where for several years she was responsible for laptop purchasing, distribution, maintenance, and first-line support. These laptops were provided to hundreds of clinical sites worldwide for the purposes of trial data capture.