Specialist Clinical Trials Pharmacist

Job overview

Hello, my name is Sergio and I am one of the Lead Pharmacists In the Clinical Trials Pharmacy department at Oxford University Hospitals NHS Foundation Trust. We have an unique opportunity for a motivated and enthusiastic pharmacist looking for a non-patient facing office-based position with no on-call cover. This is a non-clinical role, but there will be opportunities to develop clinical skills.

This role involves an emphasis on project management and meeting deadlines. You will be responsible for creating and maintaining bespoke pharmacy specific documentation for each trial you are assigned. This involves reviewing sponsor documents and collaborating with sponsors, contract research organisations and research teams. These bespoke documents serve as instructions for anyone involved in receipting, storage, dispensing, labelling, accountability, and destruction of IMPs for the trial. A high level of attention to detail is essential as requirements of the sponsor and good clinical practice (GCP) must be met.

The post will allow you to gain experience in aseptics whilst working in our clinical trials aseptic unit and ATMP Unit.

Applicants not meeting the full person specification will be considered. If successful, the applicant would be appointed to a lower band until competencies for this post are achieved. All training will be provided.

Main duties of the job

Participate in all aspects of Pharmacy Clinical Trial from setup to close down. This encompasses, but is not restricted to:

• Feasibility review to determine if trial can be supported by clinical trials pharmacy.
• Present costings to sponsors for pharmacy operational expenses during the trial .
• Setup and update study documents .
• Process amendments in timely manner.
• Proactively address challenges to ensure progression of trials, maintaining patient safety and data integrity.
• Provide updates on pharmaceutical aspects of trials to ensure alignment with project goals.
• Accuracy check oral and aseptically prepared trial medications as required.
• Co-ordinate and deliver Pharmacy support to Researchers in the Oxford University Hospitals NHS Trust.
• Work with the dedicated Clinical Trial Team, to plan workload for Pharmacy Services for the Trust and ensure operational implementation.
• Ensure that Pharmacy procedures relating to clinical trials involving (IMP’s) are in accordance with appropriate regulations (ICH/GCP, Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019, EMA, FDA, GMP) and with Research Governance Framework.
• Provide highly specialised professional expertise to Researchers in the development of clinical trial protocols involving medication and related substances and to provide advice & information regarding the application for Clinical Trial Authorisation certification from the MHRA.
• Support Clinical Trial Technicians and Senior Technical Officer

Detailed job description and main responsibilities

For a Detailed job description and main responsibilities please refer to the Job Description document attached