Clinical Trials Pharmacy Technician in Luton

An exciting opportunity to join the Pharmacy team at Bedfordshire Hospitals NHS Foundation Trust, primarily based at Luton and Dunstable University Hospital. In this role, you will support and oversee the safe, effective, and compliant delivery of investigational medicinal products (IMPs) within the hospital setting. You will work closely with the Clinical Trials Pharmacist and multidisciplinary research teams, ensuring adherence to Good Clinical Practice (GCP), Good Manufacturing Practice (GMP) and local/national regulatory frameworks.

Main duties of the job:

• Play a pivotal role in supporting and overseeing the safe, effective, and compliant delivery of investigational medicinal products (IMPs).
• Assist in the achievement of strategic developments for the pharmacy clinical trial service.
• Coordinate, provide technical oversight and manage all pharmacy‑related clinical trial activities.
• Set up and maintain clinical trial protocols within the pharmacy.
• Ensure adherence to GCP, GMP and regulatory frameworks.
• Assist with documentation control and review SOPs pertinent to research.
• Track and monitor temperature control systems for trial IMPs.
• Provide research supervision and training to pharmacy support staff.
• Contribute to service development and act as liaison with external stakeholders.

Job responsibilities:

• Ensure that all processes and documentation align with UK legislation (The Medicines for Human Use (Clinical Trials) Regulations 2004) and related amendments.
• Follow GCP and GMP guidance when dispensing and managing clinical trials involving IMPs.
• Apply safe dispensing practices at all times when dispensing and preparing IMPs.
• Provide clinical trial prescription screening service and final checking.
• Maintain safety, quality and professionalism of the service, complying with required standards.
• Manage and resolve clinical or dispensing queries regarding prescriptions and SOPs.
• Engage other Principal/Lead Pharmacists to ensure service resilience.
• Attend R&D meetings and site selection/set‑up meetings for trials.
• Support pharmacy team in trial set‑up and ongoing activity, including protocol summary revisions.
• Offer pharmaceutical trial support and advice to R&D staff.
• Collaborate on developing, reviewing and revising SOPs.
• Evaluate clinical trials service and contribute to service improvements.
• Prepare documentation for pharmacy site file, including dispensing guidelines and worksheets.
• Monitor and maintain pharmacy site files and records.
• Ensure temperature monitoring procedures for all relevant trial materials.
• Use effective systems for drug accountability (order, receipt, storage, issue, return, disposal).
• Order and receive clinical trial supplies and maintain records.
• Maintain inventory, security and storage of pharmacy clinical trials.
• Arrange disposal or return of stock at trial end or when drugs expire.
• Document quarantine procedures for drugs affected.
• Complete pharmacy close‑out and archiving at trial termination.
• Participate in audits and reviews of clinical trial processes.

Other responsibilities:

• Maintain knowledge of current regulatory guidelines.
• Maintain confidentiality at all times.
• Deliver against agreed deadlines.
• Respond quickly to variations and problems.
• Educate and train pharmacy team, other professionals and patients.
• Undertake duties as reasonably requested by Head of Pharmacy or Director of R&D.
• Carry out professional responsibilities as per General Pharmaceutical Council.
• Participate in performance review and objective setting.

Person Specification:

Qualifications:

• BTEC + NVQ Level 3 in Pharmaceutical Services plus relevant qualification or equivalent experience in GDP.
• Registration with the GPhC as a Pharmacy Technician.
• In‑house management training.
• ACPT.
• GCP Training.
• Experience in project management or complex process coordination.
• Member of RPS.
• Train the Trainer Qualification.

Experience:

• Experience working with clinical trials.
• Experience in medicines supply and clinical pharmacy in an acute trust setting.
• Experience using IT systems to support clinical activities.
• Experience formulating standard operating procedures.
• Experience in assessment, training and supervision of staff.
• Experience in auditing.

Knowledge:

• Good up‑to‑date knowledge of medicine use.
• Understanding of stock control issues.
• Awareness and application of GMP, GDP and GCP.
• Awareness of current developments in research related to CTIMP studies.
• Knowledge of NHS local and national priorities regarding clinical trials.
• Knowledge of GMP and GDP requirements and inspections.
• Practical experience of pharmaceutical risk assessment of medicines.

Personal Skills:

• Good verbal and written communication skills.
• Tact and negotiation skills.
• Ability to plan and organise ongoing service delivery.
• Ability to plan and organise training programmes.
• Ability to analyse complex problems and present information clearly.
• Demonstrated dispensing and checking accuracy.
• Awareness of teaching and learning strategies.
• Use of reporting software.

Other:

• Accurate and organised.
• Ability to work independently to meet objectives.
• Ability to work accurately under pressure and interruptions.
• Ability to maintain detailed concentration.

Disclosure and Barring Service Check: This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and a submission for Disclosure and Barring Service (formerly CRB) is required to check for any previous convictions.

Salary: £39,959 to £48,117 a year dependent on experience.