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Pharmacy Clinical Trials Support Specialist

2 months ago


Oxford, Oxfordshire, United Kingdom Oxford University Hospitals Full time

Job Overview

The Pharmacy Clinical Trials Services (PCTS) plays a crucial role in overseeing and managing all clinical trial investigational medicinal products (CTIMPs) at Oxford University Hospitals NHS Foundation Trust. This position involves handling substantial volumes of data and information, ensuring compliance with the Human Medicines Regulations and Medicines for Human Use (Clinical Trials). The role is grounded in Good Clinical Practice and ICH guidelines, with additional regulations governing aseptic dispensing under the Preparation of Aseptic Services Guidance, supported by Good Manufacturing Practice (GMP). Notably, GMP Annex addresses software and data integrity.

The successful candidate will be responsible for generating and interpreting essential information required by the Trust concerning the Pharmacy Clinical Trials service, including Aseptic Services, to support and advance its business objectives while fulfilling statutory information obligations.

Main Duties of the Role

  • Analyzing, preparing, and presenting information related to Pharmacy Clinical Trials for departmental and wider Trust use.
  • Analyzing, preparing, and presenting information concerning Pharmacy Aseptic Services for departmental and wider Trust use.
  • Assisting in the development and enhancement of the Pharmacy Clinical Trials worksheet and labeling system.
  • Supporting the creation and improvement of pharmacy clinical trial documentation within the electronic patient record system.
  • Aiding in the development of environmental monitoring IT systems.
  • Facilitating the implementation of an electronic document management system.
  • Providing ad-hoc support to address information requests from end users, including supplying data to senior pharmacy managers for Freedom of Information inquiries.
  • Delivering timely and accurate reports to external entities regarding the Trust's performance in relation to Aseptic Services.
  • Responding to information requests from both internal and external pharmacy stakeholders as authorized by the Associate Director of Pharmacy, Clinical Trials and Research, the Accountable Pharmacist, and Aseptic Services Manager.
  • Dispensing aseptic CTIMPs in a controlled environment, including associated activities.

About Oxford University Hospitals NHS Foundation Trust

Oxford University Hospitals NHS Foundation Trust is one of the largest NHS teaching trusts in the UK, offering a diverse range of general and specialized clinical services. It serves as a hub for medical education and training, comprising four hospitals.

Our values, standards, and behaviors are fundamental to the quality of clinical care we provide and the professional relationships we cultivate with patients, colleagues, and the broader community.

We are committed to Delivering Compassionate Excellence, emphasizing our core values of compassion, respect, learning, delivery, improvement, and excellence.

These values place patients at the center of our mission and underpin the high-quality healthcare we aspire to provide for everyone.