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The post holder will deliver high-quality patient care within clinical research settings, ensuring all studies are conducted safely, ethically, and in accordance with ICH Good Clinical Practice guidelines.
The role involves monitoring research participants, collecting and accurately documenting clinical research data. The post holder will work collaboratively with clinical study teams and the wider multidisciplinary team, managing their own caseload of studies.
The post holder will also be responsible for the close-down and archiving of clinical trial studies, ensuring all documentation is complete, accurate, and stored in compliance with regulatory, governance, and organisational requirements. They will develop and maintain knowledge of trial protocols, research methodologies, and relevant local, national, and international regulatory requirements.
The role is designed to support the post holder in developing the skills and expertise required to work independently as a research support officer and to become an effective and competent member of a research team.
- Prepare, process, and maintain accurate research documentation and records across all stages of the research process, in accordance with hospital policies, research governance, and ICH Good Clinical Practice guidelines.
- Coordinate and take responsibility for clinical trial close-down activities, including ensuring all study documentation is complete, accurate, and archived in line with regulatory, governance, and organisational requirements.
- Support study set-up, initiation, monitoring visits, audits, and close-down meetings, maintaining and updating Investigator Site Files and essential documents throughout the trial lifecycle.
- Collect, prepare, process, store, and track biological samples, maintaining appropriate logs and monitoring storage conditions in liaison with laboratory and hospital staff.
- Liaise effectively with multidisciplinary hospital departments, external organisations, and research teams to ensure the smooth coordination and delivery of clinical trial activities.
- Manage study data by maintaining recruitment and delegation logs, spreadsheets, and electronic databases, ensuring timely, accurate data entry, resolution of data queries, and identification of data gaps.
- Provide administrative and operational support to research teams, including coordinating meetings, minute taking, handling enquiries, and supporting staff, patients, and visitors in a professional and courteous manner.
Our new strategy, developed with the support and feedback of colleagues, patients, and partners, is our compass for the next seven years (2023-2030).
We Have Four Primary Goals
- high-quality care for all,
- being a great place to work,
- partnerships for impact, and
- research and education excellence
And we will embed health equality in all we do – taking active steps to reduce the avoidable differences in healthcare that some people face, working in partnership with communities.
Our strategy is underpinned by new values and we will work to ensure they are an everyday reality for all:
- we are compassionate,
- we are proud,
- we are inclusive, and
- we are one team
This is an exciting moment as we look to the future with clarity on what we already do well and where we need to focus our energies to make an even bigger difference for the people we serve.
About The University Hospitals Of Leicester NHS Trust
https://www.uhleicester.nhs.uk
For further details / informal visits contact: Name: Sarah Attridge Job title: Senior Data Manager Email address: sarah.attridge1@nhs.net Telephone number: 0116 258 5951
Sally Christmas
Senior Data Manager
sally.chrsitmas1@nhs.net
0116 258 7598
