Senior Clinical Trials Pharmacy Assistant

As a Senior Technician I am privileged to manage and support our technical team of Pharmacy Technicians, Assistants and Practitioners as we provide support services to clinical trial research teams on all our Trust sites throughout Oxfordshire. The Clinical Trials Pharmacy consists of Pharmacists, Technicians, Assistants and Practitioners. We work closely with research teams across the Trust and external representatives. If you are interested in an informal discussion about the Clinical Trials Pharmacy Assistant role offered within our team, I would be very pleased to chat with you. You are welcome to call the numbers below, or we can arrange an appointment for me to show you around and answer your questions. I look forward to hearing from you. The majority of correspondence will be via the e‑recruitment system; therefore you should check your emails regularly, including junk mail folders in web‑based email products.

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• 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 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‑labeling 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 stock.
  
• 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.
  

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• Assist in non‑aseptic preparation and dispensing of clinical trial medication in accordance with the RPSGB code of ethics and current legislation and guidance including Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Health and Safety, Medicines Act, Misuse of Drugs Act, Control of Substances Hazardous to Health (COSHH) and Departmental Procedures.
  
• Ensure familiar with and adhere to Pharmacy, CTASU and Trust standard operating procedures (SOPs).
  
• Ensure the disposal or recycling of medicinal products is carried out in a safe and efficient manner, in accordance with Health & Safety, COSHH regulations and Departmental Standard Operating Procedure.
  
• Participate in a programme of work based training, development and appraisal.
  
• Participate in the training and induction of pre‑registration students, technicians and assistants (if required).
  

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• Ensure confidentiality is maintained at all times.
  
• Be aware of and be involved in good customer service.
  
• Assist in audit programme.
  
• Participate in weekend, evening and bank holiday working according to rota.
  
• Any other reasonable duties as requested.
  

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• Manage risk within a progressive, honest and open environment.
  
• Familiar with major incidents policy, fire policy and local response plan.
  
• Responsible for ensuring duties comply with the Health and Safety at Work Act 1974, Statutory Regulations and Trust Policies.
  

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• Wash hands or use alcohol gel on entry and exit from all clinical areas and/or between each patient contact.
  
• Attend mandatory infection control training provided by the Trust.
  
• Contact Occupational Health if develop an infection transmittable to patients.
  

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• Adhere to associated hygiene and clothing requirements of individual work areas: absence of make‑up, removal of jewellery, wearing of protective clothing, working in a confined space up to 3 hours at a time.
  
• Participate in flexible working if introduced.
  
• Out of hours working may be included and participation in such arrangements will be required.
  
• On‑call arrangements according to site and experience.
  
• Continuous Professional Development needs will be identified and supported.
  

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• BTEC Level 2 in Pharmacy Service Skills, equivalent qualification or related degree (pharmaceutical or science degree). Applicants without these qualifications will be considered, but a relevant qualification in Pharmacy Service Skills will be required.
  
• Ability to work at an isolator fully gloved and gowned.
  
• Enthusiastic and responsible attitude.
  
• Professional approach.
  
• Attention to detail.
  
• Good interpersonal and communication skills.
  
• Uses own initiative.
  
• Team player.
  
• Adaptable to change.
  
• IT skills e.g. Word processing, spreadsheets.
  

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• Previous aseptic experience.
  
• Clinical trials experience.
  
• Well organised.
  
• Experience of working on own initiative.
  
• Experience of team working.
  
• Experience of a changing working environment.
  

Oxford University Hospitals NHS Foundation Trust is one of the largest NHS teaching trusts in the country. It provides a wide range of general and specialist clinical services and is a base for medical education, training and research. The Trust comprises four hospitals – the John Radcliffe Hospital, Churchill Hospital and Nuffield Orthopaedic Centre in Headington and the Horton General Hospital in Banbury. Our values, standards and behaviours define the quality of clinical care we offer and the professional relationships we make with our patients, colleagues and the wider community. We call this Delivering Compassionate Excellence and its focus is on our values of compassion, respect, learning, delivery, improvement and excellence.