Overview
As a team manager I am privileged to manage and support our technical team of Pharmacy Technicians, Assistants and Practitioners who provide support services to clinical trial research teams across Oxfordshire Trust sites. The Clinical Trials Pharmacy consists of Pharmacists, Technicians, Assistants and Practitioners. We work closely with research teams across the trust and external representatives. There is an opportunity for informal discussions about the Pharmacy Clinical Trials (Health Science) Associate Practitioner role within our team. You are welcome to call on the numbers below or arrange an appointment to tour and ask questions. The majority of correspondence will be via the e-recruitment system; please check emails regularly including junk mail folders.
Role Summary
As a Pharmacy Clinical Trials (Health Science) Associate Practitioner, 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 trials once open to recruitment. You will be involved in maintaining the supply chain of clinical trial medications to research nurses, maintaining financial records, completing drug accountability activities, closing down and archiving completed studies, and facilitating meetings from sponsors.
Responsibilities
1. Act as the Lead Practitioner for individual clinical trials, being the main point of contact for the 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. Utilise tact and persuasive skills as needed.
3. Ensure good communication with research patients, who may be upset, to manage situations and provide an expert service.
4. Assist with preparation for monitoring meetings, audits and inspections, and carry out any necessary work prior to these.
5. Maintain 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 checklists 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. 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 procedures and assist in the close down of other studies.
13. Be competent to: order, receipt, 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 and maintain stock levels; 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, and other Advanced Therapy Clinical Trial Aseptic Unit activities.
19. Maintain personal expertise, skills and knowledge of aseptic and non-aseptic dispensing to undertake the safe and accurate completion of product worksheets and labels, and assembly of components for dose preparation.
20. Use high levels of precision and accuracy to manipulate components in a gloved isolator to prepare doses for patients, participate in the clean room/isolator cleaning rota, and assist in environmental and physical monitoring of the CTASU.
21. Be involved in the maintenance and accurate recording of departmental records and results including staff training, environmental monitoring, cleaning, maintenance logs and worksheets.
Requirements
* NVQ Level 2 in Pharmacy Service Skills OR BTEC Level 2 Certificate in the Principles and Practice for Pharmacy Support (or equivalent).
* Extensive experience in day-to-day management and handling of IMPs.
* GCSE or equivalent Level 4 or above in Maths, English and Science.
* Completed GCP training and good knowledge 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 with good attention to detail and the ability to concentrate to undertake tasks accurately and consistently.
* Good interpersonal skills with all levels of staff and the ability to work within SOPs.
* Ability to recognise when to escalate issues and resolve simple issues; able to convey information accurately verbally and in 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 independently and use own initiative; ability to supervise junior staff and provide guidance as part of training; ability to plan daily tasks for assistants, students and apprentices.
* Willingness to work with hazardous medicines including ATMPs/GMOs and handle dry ice safely.
* Computer literate with experience of Microsoft Office.
* 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.
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.
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. 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.
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.
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