The importance of clinical research in the NHS is embedded in NUH Trust Objectives and long term strategy. The Trust Research and Innovation department recognise the vital role pharmacy has to play in the management of good quality clinical research.
As a registered pharmacy technician you will be part of the dedicated pharmacy clinical trials team delivering a high quality and responsive service to patients, clinical staff and sponsors who use our services on the City campus. There are currently about 150 studies of Investigational Medicinal Products (IMPs) which are either recruiting patients or in set up ready to begin recruitment. You will be supporting the lead technicians in the delivery of clinical trials services for all studies open to recruitment on the City campus. This will include the dispensing of IMPs, accurate completion of accountability documentation, maintenance of pharmacy files and all aspects of IMP management.
Please refer to the job description and person specification attached to the advert for the full details of the vacancy.
To carry out pharmaceutical technical duties in the provision of pharmacy services in trials of Investigational Medicinal Products, ensuring compliance with standards of clinical trial management as outlined in NUH Trust Clinical Trials Policy, Guidelines for the Safe and Secure Handling of Medicines, relevant and applicable EU and UK legislation and the Research Governance Framework for Health and Social Care 2005.
You will need to be an enthusiastic and adaptable team player, with good written and verbal communication skills, and pay close attention to detail because this is essential for this role. You will be liaising closely with other members of the pharmacy clinical trials team and you will also be in contact with Trust and University of Nottingham research staff and representatives from pharmaceutical companies who sponsor clinical research conducted within the Trust.
The post holder will be based at City Campus and will be expected to rotate between campuses, as required by the needs of the service.
With over 19,000 staff, we are one of the biggest employers in the city with a central role in supporting the health and wellbeing of our local population. We play a leading role in research, education and innovation.
Come and join our wonderful team at NUH. We are big believers in diversity and welcome new ideas to help develop our team in order to deliver world class healthcare to the vast patient populations we serve. With endless personal development opportunities available, at NUH we will endeavour to turn your job into a career!
We particularly welcome applications from people who identify as Black, Asian and Minority Ethnic, or Disabled, as we are striving to be better represented at NUH
1. To successfully complete and maintain a dispensing validation. Accurately label, assemble prescribed items, dispense and perform in process self-checking of all medicines (including cytotoxic drugs) safely and in a timely fashion by following the clinical trial specific procedures.
2. Following successful completion of the dispensing validation programme, to then complete the accuracy checking validation for accurately checking of all investigational medicinal products in a timely manner for patients recruited into clinical trials.
3. To assist with co-ordinating of the dispensary and prioritise workload to ensure effective and responsive pharmacy service, identifying delays and working to minimise these.
4. To support the development of clinical and technical services provided by the pharmacy clinical trials team.
5. To provide technical support for the interpretation, dispensing and checking of clinical trials (after completion of training and validation in accuracy checking)
6. To support the planning and efficient processing of clinical trial prescriptions, prioritising according to urgency as required.
7. To assist in the appropriate, accurate and legible completion of Investigational Medicinal Products (IMPs) and Non Investigational Medicinal Products (NIMPs) accountability documentation
8. To assist in stock control and related issues for all medicines (including IMPs, NIMPs and medicines which become available under expanded access programmes) and any other materials required by the clinical trials service to maintain operation. This will include ordering and receipt, monitoring of stock levels and expiry dates and ensuring appropriate storage conditions.
Under the direction of the departmental Chief Technician ensure adequate stock is available and ordered to ensure the smooth running of the department
• Order and receive stock via the Pharmacy computer system.
• Receive shipments of IMP via the IWRS sponsor system
• Receive and replenish stock orders from Pharmacy Stores.
• Identify, investigate and reconcile any stock discrepancies in a timely manner.
• Ensure stock is rotated and used in accordance with its expiry.
• Ensure that stock is maintained and managed, whilst minimising expenditure, stockholding and wastage.
• To participate in all stocktaking activities, ensuring procedures are followed to maintain accurate stock balances.
9. To successfully complete and maintain a shipment receipt validation of clinical trial materials from external suppliers, according to procedures.
10. To successfully complete and maintain destructions of IMP validations of clinical trial materials
11. To assist in the upkeep of dedicated clinical trials storage areas, including daily temperature control and monitoring.
12. To manage telephone and face to face enquiries from a wide range of staff groups and service users, resolving where possible and referring appropriate queries to relevant members of the trials team.
13. To support the preparation of proposed charges for pharmacy clinical trial services incurred in named protocols and the collation of information required for submission of invoices for goods or services.
14. To support the lead pharmacy technicians in assisting with the sponsor representative during their pharmacy monitoring visits
15. To assist with training and act as a role model to other members of technical and support staff providing the clinical trials service.
16. To attend team meetings and other events within the organisation, and to participate in taking comprehensive and accurate minutes.
17. To support and participate in preparation for and during clinical trial audit by sponsors and MHRA inspections
18. To assist with close-out preparations of studies that have finished with any pharmacy activities.
19. To deputise for Lead Technicians - Clinical Trials by acting as the lead in the operational management of the trials dispensary, where appropriate and when required. This includes co-ordinating the work in the trials dispensary and close liaison with the aseptic unit and trials technician within the unit to ensure timely delivery of trial IMPs for aseptic preparation.
20. To support the Lead Technicians and Trials Pharmacists in the maintenance of ongoing trials; duties to include arranging sponsor visits, overseeing sponsor representatives during visits and acting on sponsor requests in liaison with the Lead Technicians.
21. To maintain regular personal practice skills in dispensing, counselling patients on their medication, accuracy checking and the pharmacy computer system in the dispensary satellites. This will include the dispensing and safe handling of controlled drugs and cytotoxic medicines.
22. To undertake 2 yearly NIHR GCP training and complete NUH mandatory training
23. Hours to be worked over 7 days, as per local shifted and bank holiday duties: To participate in departmental weekend, bank holiday and late duty working as required. At the time of advertising, the weekend rota encompasses 2 half-day shifts every 4/5 weeks at the city campus or 1 full day shift every 4 weeks at the QMC campus. In addition, the post holder will participate in a system of flexible shifts to facilitate NUH pharmacy opening times.
24. To be adaptable to move from one work area to another at short notice in response to demands on the service
25. To participate as an appraisee in the departmental Personal Development Review (PDR) and work to achieve agreed set objectives
This advert closes on Thursday 10 Apr 2025