Act as the UHCW pharmacy department pharmaceutical link with any trials related agencies involved with clinical trials and in particular aseptic clinical trials. Ensure all dispensed clinical trials drugs comply with UK legislation, EU directives, MHRA regulations, national & local guidelines and practices. Ensure patients receive their therapy in a safe and timely manner. For all aseptic clinical trials: ensure all appropriate documentation is created, maintained and archived within an approved QA document control system. This includes standard operating procedures, accountability logs, worksheets and other relevant documents. ensure all staff receive appropriate training relating to GCP, GMP and individual trials. ensure appropriate supplies of trial medication are maintained and storage is appropriate and meets current regulations. As the specialist technician, ensure a feasibility review and assessment of any aseptic clinical trial involving pharmacy takes place and share the results of this assessment with the clinical trials team. To support the implementation of new services (e.g. implementation of ATMP studies) and regional and national initiatives, such as the HRA Technical Review and EDGE Trial Management System. Support the Senior Technician Clinical Trials to ensure that the trials workload within aseptic services laboratory is organised in an efficient and timely manner, this will include planning work in advance. Advise, when required, on matters relating to aseptically dispensed clinical trial items, including reference where appropriate to patients records retained within the department. To liaise with clinical staff in an appropriate advisory capacity. Develop the aseptic clinical trials service and work proactively to ensure the smooth introduction of new products and systems. Participate in regular audits and reviews of aseptic and cancer services, clinical trials and clinical trial standards and processes in particular relating to clinical trial practice and activity. Participate in issues related to clinical trials governance. This includes, but is not limited to, review of clinical trial incidents, participating in MHRA and other inspections, development of standard operating procedures and undertaking risk assessments. In addition, working in association with other trial technicians and trial pharmacists to ensure appropriate governance arrangements are in place and ensure appropriate mechanisms for reporting and acting on any incidents. For further details please see the attached job description. For an informal discussion about the role or further information please contact Stacey Clarke (Telephone: 024 76 966042 or Email: StaceyAnn.Clarke@uhcw.nhs.uk).