Archivist and Data Admin
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)
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