This is a split post 50/50 working in the Pharmacy Clinical Trials and ChemoCare electronic prescribing teams.
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 QMC/City campus. There are currently approximately 200 studies of Investigational Medicinal Products (IMPs) which are either recruiting patients or in set up ready to begin recruitment. You will be taking the technical lead in the medicines management and set up of clinical trials at NUH.
This is a split post working half time in the clinical trials team and split with the SACT electronic prescribing team (ChemoCare).As a team member, you will support prescribers, pharmacists, production and nursing staff across NUH campuses and our satellite at Sherwood Forest (SFH). Duties include logging and resolving queries, liaising with the supplier (CIS Oncology), ChemoCare reports, chemotherapy protocol builds, and user training. Working closely with the ChemoCare governance group, the role can touch many aspects of the patient journey & aims to improve the patient and staff experience with chemotherapy prescribing.
In addition to the below summary you need to familiarise yourself with the full Job Description and Person Specification documents attached to this advert.
You must have considerable post qualification hospital pharmacy experience and experience of clinical trials would be an advantage.
Vital for this role are good written and verbal communication and IT skills and you must also enjoy paying close attention to detail.
Your role will be central in providing a dedicated pharmacy service for clinical trial and ChemoCare support.
The role will require development and monitoring of appropriate procedures in accordance with both Good Manufacturing Practice and Good Clinical Practice as required under Clinical Trials Legislation.
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
KEY JOB RESPONSIBILITIES
Clinical Trial Responsibilities
1. In conjunction with the Pharmacy Clinical Trial team (including specialist technicians and pharmacists), the Production Department Management team and Quality Control staff, assist in the delivery of a responsive clinical trials service, to ensure good clinical practice standards (GCP) and the needs of service users are met.
2. To support the Specialist Clinical Trials Pharmacists and Chief Pharmacy Technician – Clinical Trials by managing the clinical trials, technical and support staff, through liaison with the lead trial technicians in cancer and non-cancer services.
3. To manage the day-to-day running of the clinical trials service in liaison with other lead clinical trial technicians ensuringadequate staffing levels and appropriate skill mix.
4. To supervise and participate in the dispensing of clinical trials prescriptions and requisitions.
5. To supervise and participate in the accuracy checking by pharmacy technicians of all dispensing.
6. To supervise and participate in the appropriate, accurate and legible completion of Investigational Medicinal Products (IMPs) and Non Investigational Medicinal Products (NIMPs) accountability documentation.
7. To review and update clinical trial documentation and procedures in liaison with theProduction Department Management team, the Pharmacy Clinical Trial teamand the Quality Control Department to ensure a consistent approach.
8. To assist the clinical trials pharmacists in the review and set-up of new clinical trials; review of amendments and updates to existing studies and dissemination to all relevant pharmacy staff to ensure compliance with protocols and procedures in line with GCP. Involving close working with Sponsor representatives on how research can be delivered within the Trust. This will involve writing study specific dispensing procedures, liaison with the Production Management team, research staff and liaison with the ChemoCare team (where necessary).
9. Alongside Specialist Pharmacist lead on allocated clinical trials from a pharmacy perspective and ensure GCP compliance on clinical trial delivery.
10. To manage stock control of trial medicines in liaison with the Pharmacy Clinical Trial team, including ordering and receipt, monitoring of stock levels, reconciliation of returns, monitoring of expiry dates, investigation and rectification of discrepancies in accountability and ensuring appropriate storage conditions. To lead in ensuring that correct trials medication is available for manufacture in the chemotherapy production unit in a timely manner, as required and that other associated medicines are ordered.
11. To supervise the upkeep of dedicated clinical trial storage areas, including temperature control and monitoring.
12. To measure and monitor all aspects of the clinical trial service on a regular basis liaising with the Information Technology and Finance administrators as needed.
13. To assist inthe induction and training of new pharmacy staff in clinical trial services and where necessary, nursing and medical research staff to ensure compliance with clinical trials protocols and procedures.
14. To ensure income accrued by protocols in cancer services is calculated, requested and recorded according to standard procedures.
15. To support the Principal Pharmacist – Research and Innovative Treatments and the Chief Pharmacy Technician – Clinical trials in preparation for and during clinical trial audit by Sponsors and MHRA inspections
16. To undertake project work, e.g. review of service or standards, as required providing data with which to develop the service or/and implement change as appropriate.
17. To liaise with teams within pharmacy, the NUH Trust Research and Innovation Directorate and other NHS Trusts, and trial investigators, their research delivery team representing a sponsoring organisation or personnel from national and local clinical research networks, when necessary and appropriate.
18. To undertake a regular operational commitment in order to maintain competencies and demonstrate fitness to practice as a registered pharmacy technician, which may include dispensing, (including cytotoxic and controlled drugs), counselling patients on their medication, accuracy checking (including controlled drugs) and utilisation of the pharmacy computer system.
Chemotherapy E-Prescribing responsibilities
19. To work with the supplier, specialist clinical pharmacists and Chemocare Systems Manager to support the maintenance and use of the chemotherapy e-prescribing system.
20. To review and update pharmacy chemotherapy e-prescribing procedures in liaison with the chemocare system manager; to ensure that there is a consistent approach to data input and use of the system in pharmacy.
21. To liaise with the Specialist Clinical Trial Pharmacists, ChemoCare System manager, the ChemoCare team and the Principal Investigator to support with the build of complex clinical trial protocols on the e-prescribing system and including the generation of study specific electronic trial prescriptions.
22. To be involved with the set-up of clinical trial SACT medications on the e-prescribing system to include validation of preparations, strengths, diluents and preparation expiries
23. In line with protocol amendments and process ChemoCare Change Request Forms to include the alteration of existing drugs, regimens and protocols used in cancer clinical trials where necessary.
24. To operate as a ‘super-user’ for the system. Super-user training and status will provide a high level of access to the system to allow set-up and maintenance.
25. To lead on the ChemoCare e-prescribing training programme for newly appointed staff, ensuring that appropriate training documentation is completed and maintained.
26. To provide support and advice to system users, relating to clinical use of the system, as necessary.
27. To be responsible for routine information processing from the system for department and Trust meetings, i.e. provision of data from the system for audits, including cost-saving data.
28. To work closely with the specialist clinical pharmacists and the ChemoCare system manager regarding development of the system, to maximise benefits to the department and Trust.
This advert closes on Thursday 30 Jan 2025