Ana Gil Bernabe

As Governance and Quality Manager for QUANTUM and QUOD Biobanks, my main responsibility is to ensure that the biobanks work within compliance with the regulatory bodies for clinical research, namely the Human Tissue Authority (HTA), the Health Research Authority (HRA) and the Research Ethics Committees (RECs), as well as in line with the University of Oxford Policies and common law frameworks, including the UK Data Protection Act (GDPR). To this aim, I use the Quality Management System iPassport to adhere to the Human Tissue Act Standards, in particular for the management of documents (SOPs, Risk Assessments, Forms, Working Instructions, Policies), the preparation and performance of audits, the report and management of non-compliances, the management of governance committees and for record keeping and management of relevant training. 

I split my time between the well-established QUOD and OTB biobanks and the recently formed QUANTUM biobank, with different scenarios and challenges. I bridge between the biobanks and the RGEA team (Research Governance, Ethics and Assurance), within Research Services. I also work with the data managers to ensure that appropriate consent is provided for the samples stored in the biobanks and released to researchers. With these duties, I support the biobank managers with their responsibilities.