An exciting opportunity has arisen to be the Lead Pharmacy Technician for the Clinical Trials service at NUH.
About the Role
Under the leadership and direction of the Advanced Pharmacy Technician Research and Innovation (R&I), this individual will take the lead in coordinating the technical aspects of clinical trial activities, 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 EU and UK legislation, and the Research Governance Framework for Health and Social Care 2005.
Managing the day-to-day running of the clinical trials dispensary and, with support from the Specialist Clinical Pharmacists, managing a portfolio of open clinical trials and assisting with the set-up of new clinical trials at NUH.
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.
Core Responsibilities
* Take the lead in coordinating technical aspects of clinical trial activities, ensuring compliance with clinical trial management standards, policy and legislation.
* Manage the day-to-day running of the clinical trials dispensary and support Specialist Clinical Pharmacists in managing open trials and setting up new trials at NUH.
* Supervise and participate in the dispensing of clinical trial prescriptions and requisitions.
* Supervise accuracy checking by pharmacy technicians of all dispensing where a pharmacist has previously been professionally checked, or where the professional check is not required.
* Ensure the appropriate, accurate and legible completion of Investigational Medicinal Product (IMP) and Non-Investigational Medicinal Product (NIMP) accountability documentation.
* 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.
* 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 GCP aligned protocols and procedures.
* Work closely with Sponsor representatives on how research can be delivered within the Trust and write study-specific dispensing procedures.
* Alongside the Specialist Pharmacist lead on allocated trials, ensure GCP compliance on clinical trial delivery.
* Manage stock control of trial medicines, including ordering, receipt, monitoring stock levels, reconciling returns, monitoring expiry dates, investigating and rectifying discrepancies and ensuring appropriate storage conditions.
* Lead the availability of correct trial medication for manufacture in the chemotherapy production unit and order associated medicines as required.
* Supervise the upkeep of dedicated clinical trial storage areas, including temperature control and monitoring.
* Measure and monitor all aspects of the clinical trial service on a regular basis, liaising with Information Technology and Finance administrators as needed.
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 clinical trial legislation.
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