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 and working collaboratively with clinical study teams and the wider multidisciplinary team, managing their own caseload of studies. The post holder will also be responsible for close‑down and archiving of clinical trial studies, ensuring all documentation is complete, accurate and stored in compliance with regulatory, governance and organisational requirements.
Main duties of the job
* 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, ensuring 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, 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 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.
Detailed job description and main responsibilities
* Assist with the preparation, packaging and dispatch of research samples and documentation to internal hospital departments and external organisations.
* Obtain and prepare biological samples (blood, urine, tissue, faecal), including 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 with clinical, administrative and support departments (pathology, medical records, pharmacy) to support smooth running of research activities.
* Coordinate, prepare for and participate in study set‑up, 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.
* Maintain, update and manage all essential documentation within Research Investigator Site Files throughout the full lifecycle of each study.
* 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.
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.
* Good Clinical Practice (GCP) training.
* Experience in research administration.
* Ability to use Word, Excel and PowerPoint.
* Knowledge of NHS systems and procedures.
Experience
* One year of working in an administration role.
* 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 and ECG.
* Experience of processing biological samples.
Communication and Relationship Skills
* Effectively communicate at all levels.
* 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 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.
Disclosure and Barring Service Check
A Disclosure & Barring Service check is required for the role. The Trust will pay for the check and cover the costs.
Equal Opportunities
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.
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