Clinical Trials Pharmacy Assistant

As a Senior Technician, I manage and support our Pharmacy Technicians, Assistants and Practitioners who provide support services to clinical trial research teams across all Trust sites in Oxfordshire. We work closely with research teams and external representatives. If you are interested in an informal discussion about the Clinical Trials Pharmacy Assistant role, I would be pleased to chat with you. You are welcome to call or we can arrange a meeting to answer any questions. The majority of correspondence will be via the e‑recruitment system; please check your emails regularly, including junk folders.

Responsibilities

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• Obtain and maintain Good Clinical Practice (GCP) training.
  
• Apply GCP principles 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 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‑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 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 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 generation of invoices, checking payments, etc.
  
• Assist with general administration such as organising set‑up meetings and act as 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.
  

Regulatory

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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 familiarity with and adherence to Pharmacy, CTASU and Trust standard operating procedures (SOPs).
  
• Ensure safe disposal or recycling of medicinal products in accordance with Health & Safety, COSHH regulations and Departmental SOP.
  

Teaching and Training

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• 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).
  

General Responsibilities

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• Maintain confidentiality at all times.
  
• Provide good customer service.
  
• Assist in the audit programme.
  
• Participate in weekend, evening and bank holiday working according to rota.
  
• Perform any other reasonable duties as requested.
  

Risk Management

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• All staff share responsibility for managing risk in a progressive, honest and open environment.
  
• Staff will receive necessary education, training and support to meet this responsibility.
  
• Familiarise with the Major Incidents Policy, Fire Policy and the local response plan.
  

Responsibilities for Health and Safety

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• Ensure duties are carried out in compliance with the Health and Safety at Work Act 1974, Statutory Regulations and Trust Policies and Procedures.
  
• Receive training and specialist advice where required.
  

Infection Control

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• Wash hands or use alcohol gel on entry and exit from all clinical areas and/or between each patient contact.
  
• Acknowledge mandatory infection control training provided by the Trust.
  
• Contact Occupational Health if develop a transmissible infection other than common colds or illnesses.
  

Special Working Conditions

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• Adhere to hygiene and clothing requirements of individual work areas (e.g., no make‑up, removal of jewellery, wearing of protective clothing).
  
• Work in a confined space for up to 3 hours at a time if required.
  
• Appraisal is a two‑way process.
  
• Job description is a guide and may be updated by the Chief Pharmacist.
  
• Participation in flexible working, out‑of‑hours and on‑call arrangements may be required based on experience.
  
• Continuous Professional Development needs will be identified and supported.
  

Qualifications

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• BTEC Level 2 in Pharmacy Service Skills, equivalent qualification or related degree (pharmaceutical or science).
  
• Ability to work at an isolator fully gloved and gowned.
  
• Enthusiastic, responsible, professional attitude with attention to detail.
  
• Good interpersonal and communication skills.
  
• Initiative and team player.
  
• Adaptable to change.
  
• IT skills (Word, spreadsheets).
  
• BTEC/NVQ Level 2 or willingness to undertake.
  

Desirable Criteria

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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.
  
• NHS experience.
  

Disclosure and Safeguarding

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• The postholder will have access to vulnerable people; a Disclosure and Barring Service check will be required under the Rehabilitation of Offenders Act 1974.
  

About Oxford University Hospitals NHS Foundation Trust

Oxford University Hospitals NHS Foundation Trust is one of the largest NHS teaching trusts, providing a wide range of general and specialist clinical services and serving as a base for medical education, training and research. The Trust comprises four hospitals: the John Radcliffe Hospital, Churchill Hospital, Nuffield Orthopaedic Centre in Headington and Horton General Hospital in Banbury. Our values, standards and behaviours focus on Delivering Compassionate Excellence, emphasising compassion, respect, learning, delivery, improvement and excellence.