Full job description
To represent the sponsor at meetings with internal and external organisations and other trusts hosting RCHT sponsored research and advising the group of the sponsor requirements. Support the Research Governance Manager in running the Sponsor Oversight Committee (SOC); keeping the members up to date with the status of existing research projects and new projects in the pipeline. Maintain the sponsor e-mail account, responding to enquiries, filing documents, compiling safety alerts for governance review and escalating or alerting senior staff to emails requiring action as applicable. Ensure the Trial Master Files are maintained.
This includes liaising with the Study Set-up team and R&D Governance Officer to ensure good version control and all RCHT sponsored research is filed appropriately. Oversee the sponsor research process. Compiling a manual of work instructions detailing the processes undertaken by the sponsor in the development and delivery of a research project Prepare and provide appropriate training sessions on research processes for individuals or groups as required. To be responsible for planning, organising and prioritising own workload to meet the demands from all stake holders.
To maintain regular contact with researchers for the duration of the research project to ensure a successful and timely completion of each study and all milestones are reached, recorded and appropriately reported. To provide and receive highly complex data and information and recognise and understand the sensitivity of different types of research data and communicate these when necessary. Responsibility for updating and maintaining various research databases and spreadsheets in line with national research governance requirements. To understand the principles of research governance, and good clinical practice to ensure research work generated complies with these legal and regulatory requirements.
