To centrally coordinate the research activity at the UK academic, hospital or community-based participating sites this will include:
1) Supporting and getting sites ready for recruitment by obtaining contracts and essential documents.
2) Conducting Site Initiation Visits (SIV) and study specific training sessions.
3) Liaising with sites teams during the research trial with day to day management issues.
4) Maintaining essential research documentation and filing it in the Trial Master File (TMF)
5) Completion of on site and remote monitoring visits to ensure the quality of the research conducted at each site.
6) Liaising with Data Management providing support to check the quality of the data to enable data analysis and a high quality scientific output.
7) Supporting team members to obtain regulatory and ethical approvals (ethics, R&D,MHRA, ARSAC research network)
8) Supporting the Quality Assurance team to ensure compliance with Good Clinical Practice (GCP), HHUT/partner Standard Operating Procedures (SOPs) and ethical and regulatory standards.