Archivist and Data Admin | University Hospitals of Leicester NHS Trust

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:

• Prepare, process, and maintain research-related paperwork and documentation across all stages of the research process, ensuring accuracy, completeness, and compliance with hospital policies, clinical trial regulations, and research governance requirements.
• Assist with the preparation, packaging, and despatch of research samples and documentation to internal hospital departments and external organisations, liaising as required to ensure timely and appropriate handling.
• Obtain and prepare biological samples, including blood, urine, tissue, and faecal samples, undertaking centrifuging, pipetting, preparation for storage, and coordination with laboratory and hospital staff.
• Maintain accurate logs of stored samples and monitor freezer temperatures in line with standard operating procedures.
• Liaise effectively with clinical, administrative, and support departments (including pathology, medical records, and pharmacy) to support the smooth running of research activities and the department.
• Coordinate, prepare for, and participate in study set-up, study initiation, monitoring visits, site audits, andstudy close-down meetingsconducted by sponsors and regulatory authorities.
• Take responsibility for the close-down of clinical trial studies, ensuring all study activities are completed, outstanding data queries are resolved, investigational materials and samples are accounted for, and required documentation is finalised in accordance with protocols and regulatory requirements.
• Lead and manage the archiving of clinical trial documentation, ensuring Investigator Site Files and associated study records are complete, accurate, indexed, and archived securely in line with ICH-GCP, Research Governance, sponsor requirements, and organisational retention policies.
• Take responsibility for the maintenance, management, and updating of patient recruitment logs and spreadsheets, ensuring data is accurate and retrievable from recorded sources.
• Maintain, update, and manage all essential documentation within Research Investigator Site Files throughout the full lifecycle of each study.
• Ensure all work is undertaken in accordance with study protocols, International Conference on Harmonisation – Good Clinical Practice (ICH-GCP), and Research Governance guidelines.
• Work collaboratively with research teams to ensure timely, accurate entry of clinical trial data into electronic data capture systems and databases, and to resolve data queries efficiently.
• Organise and maintain systems for systematic data collection, assist with the completion of questionnaires, and identify gaps or inconsistencies in data, communicating these to the research teams.
• Provide administrative and operational support to the Research Team, including assisting with the implementation and maintenance of research projects, minute taking for meetings, and responding to telephone and in-person enquiries.
• Act in a professional, courteous, and compassionate manner at all times when dealing with patients, relatives, staff, visitors, and external stakeholders involved in research.

(Please refer to the job description/person specification for further details on the role)

This advert closes on Tuesday 5 May 2026