Job responsibilities To assist with the acquisition and distribution of relevant trial documentation. To assist with the acquisition and distribution of study equipment/tools and ensure relevant health and safety checks are carried out in accordance with relevant Trust Policies. To assist in the preparation and submission of documentation for clinical research approvals. To create and maintain trial site files for each trial in accordance with ICH-GCP and Research Governance. Collection of patient data from medical notes and completion of case record form (CRF) and to liaise with clinical trials coordinators, research nurses and investigators to ensure accurate data collection. To transcribe/export data from medical records (paper or electronic) to CRFs (paper or electronic e-CRFs) as required by the study protocol. To ensure safe filing and storage of study documentation in accordance to research governance. Conduct quality assurance of documentation. To organise and prepare for visits by trial monitors as required by the study protocol. To take responsibility for liaising with clinical trial units regarding data queries and for checking and resolving data queries. To support the assessment of patient eligibility, in liaison with other appropriate health care professionals for clinical trial entry, involving coordination of pre study tests, obtaining results and arrangingappropriate appointments as per clinical trial protocol. To provide written and verbal information relevant to the research study and support clinical staff in the process of gaining informed consent from participants that are entering into clinical research. To deal with telephone enquiries from staff, patients and relatives, ensuring that appropriate personnel are informed in order for actions to be taken. To report any adverse events to the appropriate research nurse and/or principal investigator (PI). Presenting specific trial information at multidisciplinary team meetings. To act in a professional manner at all times when dealing with patients, relatives and representatives from both within and outside of the Trust. Co-ordination of specified trials and take responsibility for : Organisation of any necessary tests and investigations as detailed within the Sample preparation (e.g. blood, urine, tissue and faecal samples): retrieval, centrifuging, pipetting, slide making and preparation for storage, liaising with the hospital and external laboratories when appropriate. Undertaking low risk clinical duties. Maintaining logs of stored samples and freezer temperatures. Maintaining adequate stock levels of sample kits. Required to hold a phone for a short period of time to monitor freezer/fridge temperatures including during and out of office hours. Organising the logistical aspects of diagnostic specimens, packaging, and shipment, including handling of dry ice. Resolving data queries raised by sponsoring organisations. Archiving all study related material including patients notes after study closure. Reporting and submitting of Serious Adverse Events (SAEs) from this site within stipulated timeframes to sponsor organisations and the Research and Innovation Office. Tracking Serious Unexpected Event reporting. Maintaining and updating study specific site files. Notifying General Practitioners of their patients involvement in a clinical trial. As a new post holder, training will be provided for the key aspects of this role, and a period of induction identified, however, the post holder will be expected to take advantage of opportunities to upgrade their skills and to attend meetings and workshops to enhance their knowledge.