Specialist Clinical Trials Pharmacist

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, and participate in all aspects of Pharmacy Clinical Trial from setup to close down.

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• 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.
  
• Coordinate 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 2001/20/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.
  

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• M Pharm Qualification to master's degree level (4 year MPharm) or equivalent.
  
• Registered Pharmacist with the General Pharmaceutical Council (Great Britain).
  
• Wide Hospital Pharmacy experience.
  
• Problem identification and solving skills.
  
• Ability to prioritise.
  
• Good teamwork, time management and organisational skills.
  
• Good written and oral communication skills.
  
• Good negotiation and interpersonal skills.
  
• Enthusiastic and motivated; experience of working in a multidisciplinary team.
  
• Diploma/MSc in Clinical/Hospital Pharmacy or appropriate Research Qualification.
  
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  Desirable criteria
  
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  • Previous Clinical Trials or Research experience.
    
  • Aseptic Unit experience.
    
  • Research Ethics experience/training.
    
  • Involvement in developing a service.
    
  • Good IT skills.
    
  • Experience in presenting to a group.
    
  
  
  
• COVID-19: The vaccination remains the best way to protect yourself and others in healthcare settings; vaccination is encouraged.
  
• You must have appropriate UK professional registration.