Job Description

An exciting opportunity has arisen to be the Lead Pharmacy Technician for the Clinical Trials service at QMC Campus.



Under the leadership and direction of the Advanced Pharmacy Technician Research and Innovation (R&I), this individual will take the lead in co-ordinating the technical aspects of clinical trial activities in clinical trials, 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.



The post holder will be based primarily at QMC campus but will be expected to attend meetings and work at City Campus to enhance the effectiveness of this role as appropriate.



This is a varied role managing the day to day running of our clinical trials dispensary whist also, with support from the Specialist Clinical Pharmacists, managing a portfolio of open clinical trials and assist with the setting up new clinical trials at NUH.



The role of a Lead Pharmacy Technician for Clinical Trials requires a candidate with the following experience and qualifications:



General Pharmaceutical Council Registered Pharmacy Technician.

Extensive experience within hospital pharmacy

Evidence of or willingness to undergo training in pharmacy related aspects of clinical research and of clinical trial legislation This is a varied role managing the day to day running of our clinical trials dispensary whist also, with support from the Specialist Clinical Pharmacists, managing a portfolio of open clinical trials and assist with the setting up new clinical trials at NUH.

Our Team Purpose:

To provide an expert research pharmacy service that ensures the safe supply of trial medications to patients, while supporting the development of novel medicines.



This role will operate under the leadership and guidance of the Advanced Pharmacy Technician for Research and Innovation.



The Pharmacy Clinical Trials team is a highly experienced team working alongside NUH Pharmacy and Research and Innovation, delivering a high-quality pharmacy clinical trials service to both patients and research staff at NUH.



KEY JOB 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, other senior technicians and pharmacists, to ensure adequate staffing levels and appropriate skill mix.



3. To manage the day-to-day running of the clinical trials service in liaison with other lead clinical trial technicians.



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 where a pharmacist has previously professionally checked the prescription or where the professional check is not required.



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 the Production Department Management team, the Pharmacy Clinical Trial team and 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 include 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.