Clinical Trials Pharmacy Technician

Job overview

An exciting opportunity has become available to join the Pharmacy team at Bedfordshire Hospitals NHS Foundation Trust as a Clinical Trials Pharmacy Technician, primarily based at Luton and Dunstable University Hospital.

We are looking for an enthusiastic, motivated, and proactive Pharmacy Technician with experience in clinical trials pharmacy, ideally at Senior Band 5 or Band 6 level, to join our growing research team.

In this rewarding role, you will become part of a dedicated and supportive team that plays a key role in advancing research across the Trust. As a Clinical Trials Pharmacy Technician, you will have the opportunity to make a meaningful contribution to the delivery of high-quality clinical research while developing your own skills and expertise.

You will work closely with the Clinical Trials Pharmacist and receive ongoing support from the wider senior pharmacy leadership team and the Research & Development department, enabling you to thrive in a collaborative and dynamic environment.

The successful candidate should be well organised, able to manage their time effectively and work independently on the research trials being run in the department. They will also have the communication skills to explain medication instructions to patients about their trial medication while  maintaining patient confidentiality at all times.

Main duties of the job

• To play a pivotal role in supporting and overseeing the safe, effective, and compliant delivery of investigational medicinal products (IMPs) within the hospital setting.
• Actively assist in the achievement of strategic developments planned for the pharmacy clinical trial service.
• Working closely with the clinical trials pharmacist and multidisciplinary research teams, the post holder is responsible for the coordination, technical oversight, and operational management of all pharmacy-related clinical trial activities. This includes setting up and maintaining clinical trial protocols within the pharmacy, ensuring adherence to Good Clinical Practice (GCP), Good Manufacturing Practice (GMP) and local/national regulatory frameworks.
• To assist with documentation control for the department, reviewing Standard Operating Procedures (SOPs) pertaining to research, and tracking and monitoring temperature control systems for trial IMPs
• As a senior member of the pharmacy team, the post holder will provide research supervision and training to pharmacy support staff, contribute to service development, and act as a key liaison between the pharmacy department and external research stakeholders.

Detailed job description and main responsibilities

• Working with the Lead Pharmacist of Clinical Trials and Quality Assurance, to provide a comprehensive Clinical Trials service which: a.    Ensures that all processes and documentation are completed in line with UK legislation (The Medicines for Human Use (Clinical Trials) Regulations 2004) and associated amendments. b.    Ensures that Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) guidance is followed when dispensing and managing Clinical Trials that involve Investigational Medicinal Products (IMPs). c.     Ensures that safe dispensing practices are applied and adhered to at all times when dispensing and preparing Investigational Medicinal Products (IMPs). d.    Provides a Clinical Trial prescription screening service and final checking to ensure that the service is efficient, effective and safe in accordance with the particular study protocol. e.    Ensures that the safety, quality and professionalism of the service is maintained and complies with the required standards at all times. f.      Manages and resolves any clinical or dispensing queries relating to Clinical Trials prescriptions and Clinical Trial Protocols / Pharmacy SOPs relating to protocols. g.    Works with other Principal / Lead Pharmacists to engage them in the Clinical Trials Service and ensure resilience within the service.
• To contribute to the provision of Pharmacy Clinical Trials service with individual clinical service lines, Research and Development (R&D) department and across the Trust: a.    To attend the R&D meetings. b.    To attend site selection, as necessary, as well as initiation and set up meetings for individual trials.
• To oversee and support the pharmacy team in Clinical Trial set-up and provide continued support for the running and maintenance of current trial activity. This will include the generation and revision (following protocol amendments) of local study specific protocol summaries.
• To provide pharmaceutical Clinical Trial support and advice to R&D staff (including clinical research nurses and consultants) conducting all CTIMP studies, commercial and non-commercial, to enable good IMP management and patient safety.
• To work with the Pharmacy Clinical Trials team in the identification, development, review, and revision of new standard operating procedures SOPs which cover the Clinical Trials activities within that department.
• To evaluate the Pharmacy Clinical Trials service in conjunction with the Lead Pharmacist for Clinical Trials and contribute to service improvements within the Pharmacy department to promote the role of Pharmacy in the overall conduct of Clinical Trials across the Trust.
• Prepare documentation for the pharmacy site file including dispensing guidelines, worksheets, ensuring conformity with requirements of protocol.
• Ensure ongoing monitoring of pharmacy site files is undertaken, ensuring accurate completion of records.
• Ensure procedures for temperature monitoring of all relevant clinical trials materials are followed, with accurate records available for clinical trial monitors to refer to.
• Ensure effective systems and procedures are utilised to cover all stages of the drug accountability process: order, receipt, storage, issue, returns and disposal/destruction.
• To order and receive clinical trial supplies as necessary and ensure appropriate records are kept.
• Ensure procedures for temperature monitoring of all relevant clinical trials materials are followed, with accurate records available for clinical trial monitors to refer to.
• To maintain an orderly and suitable inventory of all pharmacy clinical trials in the appropriate storage area.
• To manage the security and maintenance of all clinical trial drugs.
• To arrange for the disposal or return of stock at the end of a trial, or when drugs pass their expiry dates as per procedure.
• Ensure correct procedure for quarantine is followed and documented for all drugs affected.
• Upon trial termination, ensure pharmacy close-out and archiving is carried out in line with regulatory and contractual requirements.
• Participate in regular audits and reviews of clinical trials, clinical trial standards and processes in particular relating to clinical trial practice and activity.

Other

• Maintain knowledge of current regulatory guidelines and regulations pertaining to requirements for this post.
• To ensure confidentiality is maintained at all times.
• To be responsible for delivery against agreed deadlines.
• To be able to respond quickly to variations and problems as they arise.
• To participate in the education and training of the pharmacy team, other healthcare professionals and patients as appropriate.
• To undertake other duties as reasonably requested by the Head of Pharmacy (LDH) or the Director for Research and Development.
• To carry out the professional responsibilities of a pharmacy technician in accordance with the General Pharmaceutical Council.
• To participate fully in the individual performance review and objective setting process of the Trust.