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Detailed job description and main responsibilities

Your core role in Clinical Trials Pharmacy would be to:

Obtain and maintain Good Clinical Practice (GCP) training, apply principles of GCP in the management of clinical trials and work within the Medicines for Human Use (Clinical Trial) Regulations 2004 and EU directive relating to Clinical Trials, communicate with Investigators, Research Nurses, Trust R&D, Sponsors, Clinical Research Associates and Pharmacy staff during the set-up and running of a clinical trial, ensure clinical trial protocols and SOPs are followed during dispensing of clinical trial investigational medicinal products and other drugs included in the protocol, order and receive in clinical trial drugs, process receipt paperwork and acknowledge receipt on IVRS (Electronic Medication Supply) systems, check stock levels and expiry dates of clinical trial drugs and keep balance logs up to date, assist with the packing down and re-labelling of clinical trial drugs if required, assist with the preparation for monitoring meetings, audits and inspections, maintain Clinical Trial files ensuring items can easily be located and are presentable,  process returned clinical trial drugs and ensure the paperwork is kept in order,  participate in the statutory temperature monitoring of clinical trial stocks, assist with the destruction of clinical trial medication, assist with the closedown and archiving of clinical trial files, represent the Clinical Trials Team to update the dispensary staff at meetings, liaise with Research Nurses to update them on trial progress, stock levels etc,  assist in the collection of data as requested by the Senior Clinical Trial Technician or Clinical Trial Pharmacists,  assist in maintaining financial records, including the generation of invoices, checking payments etc,  assist with general administration such as organising set up meetings etc and be a point of contact within the Clinical Trials Pharmacy Team, maintain clinical trial filing systems and drug accountability documentation for clinical trials, use the computer system and other information technology in all areas of Pharmacy.

Additionally, you would be involved in supporting Clinical Trial Aseptic Unit to:

Participate in the day to day running of the CTASU in line with the rota system, participate in safe systems of work and documentation of these,  undertake safe and accurate preparation of a wide range of aseptic products on a daily basis, including cytotoxics, epidurals, antibiotics, injectables, novel agents and monoclonal antibodies,  maintain personal expertise, skills and necessary knowledge of the technical aspects of aseptic and non-aseptic dispensing, ensure products are prepared according to standard operating procedures (SOPs), assemble drugs and consumables required for preparation of aseptic products, accurately recording batch numbers and expiry dates,  be responsible for the accurate completion of product worksheets and labels, assigning batch numbers to aseptically prepared products, accurately and safely label aseptically prepared products, facilitate the quality assurance of products and to notify the Senior Aseptic Technician of any incidents and procedural deficiencies, be responsible for ensuring finished products are packed prior to distribution to ensure the prompt and safe delivery, ensure finished products are transported in the appropriate environment taking into account any physical & legal requirements,  be responsible for unpacking and receipt of deliveries, undertake regular expiry date checking to identify expired or short dated stock, be responsible for monitoring drug stock and consumable levels and replenishing, ensure that all equipment within CTASU is in good working order and serviced regularly, participate in the clean room/isolator cleaning rota, assist in environmental and physical monitoring of the CTASU, be involved in the maintenance of departmental records including staff training, environmental monitoring, cleaning, maintenance logs and worksheets, where applicable to be involved in the delivery of drugs to clinical areas