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Pharmacy Clinical Trials Coordinator

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 necessitates the handling of substantial volumes of data and information, ensuring compliance with Human Medicines Regulations and Medicines for Human Use (Clinical Trials), which are supported by Good Clinical Practice and ICH guidelines. For CTIMPs that require aseptic dispensing, additional regulations apply, governed by the Preparation of Aseptic Services Guidance, underpinned by Good Manufacturing Practice (GMP). Specifically, GMP Annex addresses software and data integrity.

The individual in this role will be responsible for generating and interpreting the information necessary for the Trust concerning the Pharmacy Clinical Trials service, including Aseptic Services, to support and advance its business objectives while fulfilling the Trust's statutory information obligations.

Key Responsibilities

  • Analyzing, preparing, and presenting information related to Pharmacy Clinical Trials for departmental and wider Trust use.
  • Analyzing, preparing, and presenting information related to Pharmacy Aseptic Services for departmental and wider Trust use.
  • Assisting in the development and maintenance of the Pharmacy Clinical Trials worksheet and labeling system.
  • Supporting the creation and management of pharmacy clinical trial documents 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 organizations regarding the Trust's performance in relation to Aseptic Services.
  • Responding to information requests from both internal and external sources as authorized by the Associate Director of Pharmacy, Clinical Trials and Research, the Accountable Pharmacist, and the Aseptic Services Manager.
  • Dispensing aseptic CTIMPs in a controlled environment and performing associated tasks.

About Oxford University Hospitals NHS Foundation Trust

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

Our core values, standards, and behaviors define the quality of clinical care we provide and the professional relationships we cultivate with our patients, colleagues, and the broader community.

We are committed to delivering compassionate excellence, emphasizing our values of compassion, respect, learning, delivery, improvement, and excellence.

These principles place patients at the center of our efforts and underpin the high-quality healthcare we aspire to provide for ourselves and our families.