Archivist and Data Admin

Job overview

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.

Working for our organisation

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

• 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, and study close-down meetings conducted 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)

Person specification

Commitment to Trust Values & Behaviours

• Must be able to demonstrate behaviours consistent with the Trust’s Values and Behaviours

Training & Qualifications

• Educated to GCSE standard or equivalent, including English and Maths
• OCR/RSA III-qualified or equivalent

• GCP training
• Research experience
• Ability to use Word, Excel and Powerpoint
• Knowledge of NHS systems and procedures

Experience

• One year of working in an administration role
• Managing diaries
• Dealing with customers/patients
• Co-ordinating complex pathways
• Minute-taking

• Oncology / haematology / research administration experience
• Understanding of site- specific medical terminology
• Able to undertake venepuncture & ECG
• Experience of processing biological samples

Communication and Relationship Skills

• Effectively communicate at all levels
• Effectively communicate in emotive situations, giving clear and concise information to patients
• Demonstrate tact and diplomacy
• Ability to manage conflicting priorities
• Demonstrate knowledge of patient confidentiality and data protection
• Ability to work across various specialities / areas seamlessly

• Exposure to dealing with complaints

Analytical and Judgement skills

• Act on own initiative
• Work without close supervision to ensure the effective management of patients within local and national targets

Physical Skills

• Ability to use a computer and other office equipment

Planning and Organisation Skills

• Proven planning and organisation skills with the ability to prioritise workloads
• Experience of co-ordinating a complex pathway

Equality, Diversity and Inclusion

• Able to demonstrate a commitment to and understanding of the importance of treating all individuals with dignity and respect appropriate to their individual needs.
• All staff are expected to engage in compassionate and inclusive leadership in the provision of high quality care and interactions with others

Additional Information

Please submit your application form without delay to avoid disappointment; we will close vacancies prior to the publishing closing date if we receive a sufficient number of completed application forms.

Please check the email account (including your junk mail) that you supplied as part of your application on a regular basis following the closing date and throughout the recruitment process, as this is how we will communicate with you.

UHL is an equal opportunities employer. We aim to employ a workforce that reflects the diverse communities we serve. We welcome applications from people from all backgrounds who match our job criteria.

Applicants who have a disability and meet the essential criteria for the job will be interviewed if you indicate you wish to be considered under the Guaranteed Interview Scheme. If you require a reasonable adjustment at any stage of the recruitment process please make the recruitment services team aware as soon as possible.

UHL is committed to helping colleagues balance the demands of both their work and personal needs through flexible working arrangements wherever reasonably practicable and subject to service needs.

Disclosure and Barring Service Check

Please note if you are successful in obtaining this position and the post involves regulated activity you will be required to undertake a Disclosure & Barring Service check.

The Trust will pay for the check initially and the money will then be deducted from your salary over a three month period commencing on your first month's payment.

The current price of a check is £38 for an enhanced and £18 for a standard check.

COVID 19 Risk Assessment

Due to the current Covid pandemic we have introduced a staff risk assessment into our pre-employment process. This now forms part of the mandatory pre-employment checks that will be carried out if you receive a conditional offer.

The risk assessment is intended to ensure you are able to safely perform your duties in any of our work areas, and if you have been identified as being particularly vulnerable to coronavirus. Our main aim is to reduce risk and to ensure the safety of all new starters to the Trust as well as current staff, patients and visitors.

If it is identified that you are within a vulnerable category, we will endeavor to make reasonable adjustments to accommodate this through discussions with both Occupational Health and your recruiting manager.

Covid Vaccination Status

Covid-19 vaccination remains the best way to protect yourself, family, colleagues and our patients/service users from the Covid-19 virus. We therefore continue to encourage our current and potential colleagues to get vaccinated.

We welcome applications from the diverse community of Leicester, Leicester and Rutland, to help deliver healthcare services that meets the needs of our diverse communities.

At University Hospitals of Leicester NHS Trust we recognise that Artificial Intelligence (AI) tools can be used as a supportive aid during the job application process, for example to generate ideas, improve grammar, or support formatting. . We do however encourage applicants to carefully review any AI‑supported content to ensure their application genuinely and accurately reflects their own skills, experience, and motivation for the role.