Pharmacy Clinical Trials (Health Science) Associate Practitioner

As a team manager I am privileged to manage and support our fantastic technical team of Pharmacy Technicians, Assistants and Apprentices as we provide support services to clinical trial research teams on all our Trust sites throughout Oxfordshire. The Clinical Trials Pharmacy consists of Pharmacists, Technicians, Assistants and Apprentices. We work closely with research teams across the trust and external representatives. If you are interested in an informal discussion about the Pharmacy Clinical Trials (Health Science) Associate Practitioner role offered within our team then I would be very pleased to chat with you. You are more than welcome to call on the numbers below or even better, we can make an appointment for me to show you around and answer your questions. I look forward to hearing from you. The majority of correspondence will be via the e-recruitment system; therefore you should check your emails regularly including junk mail folders in web-based email products., As a Pharmacy Clinical Trials (Health Science) Associate Practitioner in our team, you will have an extremely varied role. You will act as the Lead Practitioner for individual clinical trials, being the main point of contact for the clinical trials once open to recruitment. You will be involved in maintaining the supply chain of Clinical Trial medications to research nurses who deliver treatment to patients, maintaining financial records, completing drug accountability activities, closing down and archiving of completed studies, as well as facilitating meetings from sponsors., 1. Act as the Lead Practitioner for individual clinical trials being the main point of contact for the clinical trials once open to recruitment. 2. Ensure good communication with Investigators, Research Nurses, Trust Research & Development, Sponsors, Clinical Research Associates and Pharmacy staff during the running of a clinical trial. Utilises tact and persuasive skills as needed. 3. Ensure good communication with research patients, who may at times be upset, to manage situations and provide an expert service. 4. Assists with the preparation for monitoring meetings, audits and inspections, and carry out any necessary work prior to this. 5. Maintains Clinical Trial files ensuring items can easily be located and are presentable. 6. Liaise with Research Nurses to update them on trial progress, stock levels etc. 7. Responsible for the generation of invoices for allocated studies and assist with invoices for other studies as needed. 8. Complete GCP checklists for allocated studies on a regular basis as indicated by objectives and procedures and assist in the completion of GCP check lists for other studies 9. Maintain Good Clinical Practice (GCP) training. 10. Apply principles of GCP in the management of clinical trials and work within the Medicines for Human Use (Clinical Trial) Regulations 2004 and EU directive relating to Clinical Trials. 11. To ensure clinical trial protocols and SOPs are followed during dispensing of clinical trial investigational medicinal products and other drugs included in the protocol. 12. Close down allocated clinical trials within the timeframes indicated by objectives and procedure and assist in the close down of other studies 13. Be competent to:

• Order, receipt, undertake stock acknowledgement, pack-down, label, undertake returns and destruction of clinical trial IMPs and other medicines.
• Dispense doses for patients in clinical trials
• Undertake expiry date and stock level checks are carried out and that stock levels are maintained.
• Temperature monitor clinical trial stocks and manage an excursion.
14. Assist in the collection of data as requested by the Senior Clinical Trial Technician or Clinical Trial Pharmacists. 15. Follow SOPs for own area of work. Propose changes or comment on changes to SOPs as required. 16. Represent the Clinical Trials Team to update the dispensary staff at meetings. 17. Develop knowledge and skills for the safe use of equipment in the department: Waysafe cabinet and take responsibility for its safe use by others. 18. Safely handle hazardous materials: chemotherapy, genetically modified investigational medicinal products, other Advanced TherapyClinical Trial Aseptic Unit (CTASU) 1. To maintain personal expertise, skills and necessary knowledge of the technical aspects of aseptic and non-aseptic dispensing to undertake the safe and accurate completion of product worksheets and labels, assembly of components for dose preparation, preparation of a wide range of aseptic products. 2. Use high levels of precision and accuracy to manipulate components in a gloved isolator to prepare doses accurately and safely for patients. 3. To participate in the clean room/isolator cleaning rota. 4. To assist in environmental and physical monitoring of the CTASU. 5. To be involved in the maintenance and accurate recording of departmental records and results including staff training, environmental monitoring, cleaning, maintenance logs and worksheets., The postholder will have access to vulnerable people in the course of their normal duties and as such this post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service to check for any previous criminal convictions.

A successful candidate should possess NVQ Level 2 in Pharmacy Service Skills OR BTEC Level 2 Certificate in the Principles and Practice for Pharmacy Support and have extensive experience of the day-to-day management and handling of IMPs. Applicants without these essential qualifications will not be considered.,
• BTEC / NVQ Level 2 Pharmacy Services
• GCSE or equivalent Level 4 or above in Maths, English and Science
• Extensive experience of the day-to-day management and handling of IMPs
• Completed GCP training and has a good knowledge and understanding of how it affects pharmacy responsibilities and IMP management
• Ability to work fully gloved and gowned in an isolator
• Ability to handle medicines safety including deep frozen medicines
• Reliable
• Ability to show attention to detail in work
• Ability to concentrate to undertake tasks accurately and consistently
• Good interpersonal skills with all levels of staff
• Ability to work within SOPs
• Understand when to escalate issues found and can resolve simple issues
• Ability to convey information accurately - verbally and written reports or email
• Professional approach and experience of team working
• Enthusiastic and responsible attitude towards work
• Good organisational skills and prioritisation of work
• Able to work alone and able to use own initiative
• Ability to supervise other junior staff and provide guidance on how to undertake tasks as part of their training
• Ability to plan daily tasks for assistants, students, apprentices
• To work with hazardous medicines including ATMPs/GMOs, handle dry ice safely
• Computer literate with experience of working with the Microsoft Office package
• Vaccination Status - As required by OUH occupational health / NHS
Desirable criteria
• Science degree BSc
• NHS experience
• Aseptic experience
• Awareness of legislation and standards relating to Good Clinical Practice
• Able to acknowledge, appreciate and conform to change that occurs
• Experience of working on own initiative
  
  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.
The Trust comprises of four hospitals - the John Radcliffe Hospital, Churchill Hospital and Nuffield Orthopaedic Centre in Headington and the Horton General Hospital in Banbury. Our values, standards and behaviours define the quality of clinical care we offer and the professional relationships we make with our patients, colleagues and the wider community. We call this Delivering Compassionate Excellence and its focus is on our values of compassion, respect, learning, delivery, improvement and excellence. These values put patients at the heart of what we do and underpin the quality healthcare we would like for ourselves or a member of our family. Watch how we set out to deliver compassionate excellence via the OUH YouTube channel., 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. The Trust comprises four hospitals - the John Radcliffe Hospital, Churchill Hospital and Nuffield Orthopaedic Centre in Headington and the Horton General Hospital in Banbury. For more information on OUH please view OUH At a Glance by OUHospitals - Issuu Our values, standards and behaviours define the quality of clinical care we offer and the professional relationships we make with our patients, colleagues and the wider community. We call this Delivering Compassionate Excellence and its focus is on our values of compassion, respect, learning, delivery, improvement and excellence. These values put patients at the heart of what we do and underpin the quality healthcare we would like for ourselves or a member of our family. Watch how we set out to deliver compassionate excellence via the OUH YouTube channel.