About this role
Job summary
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
1. To play a pivotal role in supporting and overseeing the safe, effective, and compliant delivery of investigational medicinal products (IMPs) within the hospital setting.
2. Actively assist in the achievement of strategic developments planned for the pharmacy clinical trial service.
3. 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.
4. 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
5. 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.
About us
Bedfordshire Hospitals NHS Foundation Trust provides hospital services to a growing population of around 700,000 people living across Bedfordshire and the surrounding areas across two busy hospital sites in Bedford and Luton. Both hospital sites offer key services such as A&E, Obstetrics-led Maternity and Paediatrics. You will be joining a friendly, high performing Trust committed to ensuring the health and wellbeing of staff. As one of the largest NHS Trusts in our region you will have access to a programme of high quality training and development to help you grow your career. The Trust continues to be committed to delivering the best patient care using the best clinical knowledge and technology available.
Our values
We not only recruit based on qualifications and experience - we recruit individuals who demonstrate the behaviours which underpin our Trusts core values. We achieve this by using values based recruitment. We are dedicated to making our recruitment practices as inclusive as possible for everyone, we are committed to promoting equality and diversity and creating a culture that values differences.
Please note that vacancies may close prior to the advertised closing date when sufficient number of applications have been received. All new staff will be subject to a probationary period covering first 6 months in post. Travel between hospital sites may be required. Please review all documents attached to ensure you familiarize yourself with all requirements of the job.
Job description Job responsibilities
1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. Prepare documentation for the pharmacy site file including dispensing guidelines, worksheets, ensuring conformity with requirements of protocol.
8. Ensure ongoing monitoring of pharmacy site files is undertaken, ensuring accurate completion of records.
9. Ensure procedures for temperature monitoring of all relevant clinical trials materials are followed, with accurate records available for clinical trial monitors to refer to.
10. Ensure effective systems and procedures are utilised to cover all stages of the drug accountability process: order, receipt, storage, issue, returns and disposal/destruction.
11. To order and receive clinical trial supplies as necessary and ensure appropriate records are kept.
12. Ensure procedures for temperature monitoring of all relevant clinical trials materials are followed, with accurate records available for clinical trial monitors to refer to.
13. To maintain an orderly and suitable inventory of all pharmacy clinical trials in the appropriate storage area.
14. To manage the security and maintenance of all clinical trial drugs.
15. 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.
16. Ensure correct procedure for quarantine is followed and documented for all drugs affected.
17. Upon trial termination, ensure pharmacy close-out and archiving is carried out in line with regulatory and contractual requirements.
18. Participate in regular audits and reviews of clinical trials, clinical trial standards and processes in particular relating to clinical trial practice and activity.
Other
1. Maintain knowledge of current regulatory guidelines and regulations pertaining to requirements for this post.
2. To ensure confidentiality is maintained at all times.
3. To be responsible for delivery against agreed deadlines.
4. To be able to respond quickly to variations and problems as they arise.
5. To participate in the education and training of the pharmacy team, other healthcare professionals and patients as appropriate.
6. To undertake other duties as reasonably requested by the Head of Pharmacy (LDH) or the Director for Research and Development.
7. To carry out the professional responsibilities of a pharmacy technician in accordance with the General Pharmaceutical Council.
8. To participate fully in the individual performance review and objective setting process of the Trust.
Person Specification
Qualifications Essential
Knowledge, skills and experience equivalent to 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
Desirable
Experience in project management or complex process coordination Member of RPS Train the Trainer Qualification
Experience Essential
Experience of working with clinical trials Experience of medicines supply and clinical pharmacy in an acute trust setting Experience in using IT systems to support clinical activities Experience of formulating standard operating procedures
Desirable
Experience of assessment, training and supervision of staff Experience in auditing
Knowledge Essential
Good up to date knowledge of medicine use Understanding of issues involved in stock control Awareness of, and ability to demonstrate implementation in practice of, GMP, GDP and GCP Awareness of current developments in research related to CTIMP studies
Desirable
Knowledge and awareness of local and national priorities in the NHS related to clinical trials Knowledge and experience of GMP and GDP requirements and inspections Practical experience of pharmaceutical risk assessment of licensed and unlicensed medicines, pharmacy practice and suppliers/manufacturers
Personal Skills Essential
Good verbal and written communication skills Good listening skills Tact and negotiation skills Computer literacy Ability to plan and organise on-going service delivery Ability to plan and organise on-going training programmes Ability to analyse complex problems and present information in a clear and concise manner Accurate numeracy skills Demonstrated dispensing and checking accuracy
Desirable
Awareness of teaching and learning strategies and ability to put them into practice Use of reporting software
Other Essential
Accurate and organised Ability to plan and organise on-going service delivery Ability to plan and organise on-going training programmes Ability to analyse complex problems and present information in a clear and concise manner Able to work independently to meet agreed objectives Able to work accurately under pressure and interruptions. Able to maintain detailed concentration
Disclosure and Barring Service Check This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Certificate of Sponsorship Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
UK Registration
Applicants must have current UK professional registration. For further information please see NHS Careers website (opens in a new window).
Employer details Employer name Bedfordshire Hospitals NHS Foundation Trust
Address Luton and Dunstable University Hospital
Lewsey Road
Luton
LU4 0DZ
United Kingdom
Employer's website https://www.bedfordshirehospitals.nhs.uk/working-here/ (Opens in a new tab)