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.
Responsibilities
- 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.
- 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.
- Act in a professional, courteous, and compassionate manner at all times when dealing with patients, relatives, staff, visitors, and external stakeholders involved in research.
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