Senior Clinical Trials Pharmacy Assistant

3 weeks ago

Oxford, United Kingdom Oxford University Hospitals Full time

Job overview

Hello, my name is Sergio and I am one of the Lead Pharmacists in the Clinical Trials Pharmacy department. We are a multicultural team which values diversity, inclusion, collaboration and a commitment to excellence. 

We are seeking a dynamic Clinical Trials Pharmacist to play a pivotal role in advancing our portfolio of innovative clinical trials. This position offers a unique opportunity to combine pharmaceutical and project management expertise. Your responsibilities will include the updating and preparation of in-house documentation, overseeing supply, storage of investigational medicinal products, and thereby contributing to the success of pharmacy participation in clinical trials that shape the future of medicine.

You will be key in orchestrating and managing pharmacy aspects within our clinical trials. Your responsibilities will extend beyond traditional pharmacy roles, involving strategic planning, resource coordination, and project execution to ensure successful completion of clinical trials. If you are a forward-thinking pharmacist eager to integrate project management skills into your role, this is the opportunity for you.

The post will allow you to gain experience in Aseptic Preparation of the IMPs 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 specific documents . Process amendments in timely manner. Proactively address challenges to ensure progression of trials, maintaining patient safety and data integrity. Provide regular 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 the workload for Pharmacy Services for the Trust and ensure operational implementation. Ensure Pharmacy procedures relating to clinical trials involving Investigational Medicinal Products are in accordance with appropriate regulations (ICH/GCP, EU Directive //EC, 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. Interact with and support Clinical Trial Technicians and Senior Technical Officer. Working for our organisation

Oxford University Hospitals NHS Foundation Trust is one of the largest NHS teaching trusts in the country. It provides a wide range of general and specialist clinical services and is a base for medical education, training and research. Clinical Research at OUH NFT is conducted to the highest standards of excellence and plays a vital role in tackling the biggest healthcare challenges of the st century aiming to improve the care we offer to our patients.

With a portfolio of around active clinical research studies, OUH is one of the largest and most productive research-active university hospital NHS Trusts nationally. According to a new league table of research supported by National Institute for Health Research Clinical Research Network, OUH recruited patients in studies last year. Our broad research portfolio covers conditions including cancer, dementia and stroke.

In OUH opened its new facility to prepare a new range of medicines known as advanced therapy medicinal products (ATMPs), which are based on gene, tissue or cell therapy products. The new unit comes against a backdrop of rapid advances in treatments such as gene and cell therapies, monoclonal antibodies or mRNA vaccines, many of which are being investigated and developed in Oxford, especially through the Oxford BRC.

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