Overview
The Clinical Trials Pharmacy consists of Pharmacists, Technicians, Assistants and Apprentices. We work closely with research teams across the trust and external representatives. Our team sets up Pharmacists and Technicians to work on monthly R&D targets to open new Clinical Trials and we currently have over 300 active studies. An informal discussion about the Pharmacy Clinical Trials (Health Science) Practitioner role is welcome.
Most correspondence will be via the e-recruitment system; please check your emails regularly including junk mail folders in web-based email products.
Responsibilities
1. Set up trial specific study files and generate all necessary essential pharmacy documentation in preparation for pharmacy sign off.
2. Attend multidisciplinary team meetings with investigators to initiate, manage and close down trials ensuring pharmacy participation.
3. Review a clinical trial amendment and progress the amendment in accordance with SOPs to ready for Pharmacy Green Light approval.
4. Manage own workload and plan activities to ensure trial setup and amendment timelines can be met.
5. Work with colleagues in the Clinical Trials Team to assist in planning the workload for setup of new trials and amendments in accordance with R&D Monthly Lists.
6. Maintain clear communication with Investigators, Research Nurses, Trust Research & Development, Sponsors, Clinical Research Associates and Pharmacy staff during the setup and running of a clinical trial; provide complex and detailed information regarding pharmacy aspects of the trial.
7. Discuss complex issues in a trial and resolve them by explanation and persuasive skills.
8. Maintain personal expertise, including knowledge of regulations and requirements for Clinical Trials developed through training and degree-level education.
9. Use knowledge to compare options for how a trial could be run and set up, and judge the best route to take.
10. Seek advice from senior colleagues to facilitate timely setup and plan when studies will be ready for review and Pharmacy Green Light approval.
11. Operate to standards of excellence in customer care with a strong patient focus.
12. Communicate effectively with research patients, including handling situations with patients who may be upset to provide an expert service.
13. Maintain Good Clinical Practice (GCP) knowledge and apply GCP principles in the management of clinical trials and compliance with Medicines for Human Use (Clinical Trial) Regulations 2004 and EU directives.
14. Liaise with other centres for clinical research to ensure common standards of practice.
15. Participate in implementing changes and improvements to the CTPT.
16. Undertake day-to-day supervision of junior staff and trainees in the management of IMPs and setting up new trials, planning workload as required.
17. Support the training of medical, nursing and pharmacy staff in all aspects of handling drugs in clinical trials.
18. Maintain accurate and contemporaneous records, with version control of documents and filing in accordance with SOPs.
19. Prepare accurate financial records, including invoicing, checking of invoices and authorisation of invoices for payment.
20. Order, receipt, stock acknowledgement, pack-down, label, undertake returns and destruction of clinical trial IMPs and other medicines; maintain, close down and archive clinical trial pharmacy files to ensure regulatory compliance.
21. Carry out expiry date and stock level checks and monitor temperatures of clinical trial stocks, managing any excursions.
22. Assist with preparation for monitoring meetings, audits and inspections and represent the Clinical Trials Team to update the dispensary staff at meetings.
23. Propose changes and comment on changes to SOPs; develop knowledge and skills for the safe use of equipment in the department and ensure safe use by others.
24. Safely handle hazardous materials including chemotherapy, genetically modified investigational medicinal products, other ATMPs and dry ice according to departmental and Trust SOPs.
25. Where required, participate in Clinical Trial Aseptic Unit (CTASU) duties including aseptic and non-aseptic dispensing, dose preparation and related record-keeping.
26. Maintain environmental monitoring and staff training records and assist in environmental and physical monitoring within the CTASU.
Qualifications
* NVQ Level 2 in Pharmacy Service Skills OR BTEC Level 2 Certificate in the Principles and Practice for Pharmacy Support
* Degree in a relevant scientific subject
* Extensive experience in day-to-day management and handling of IMPs
* GCSE or equivalent Level 4 or above in Maths, English and Science
* BTEC / NVQ Level 2 Pharmacy Services
* Completed GCP training and good knowledge of how it affects pharmacy and IMP management
* Ability to work fully gloved and gowned in an isolator
* Reliable with good attention to detail
* Strong interpersonal skills and professional team-working experience
* Enthusiastic, responsible attitude and good organisational skills with prioritisation
* Able to work alone and use own initiative
* Basic all-round knowledge of the Pharmacy department and services
* Ability to critically evaluate narrative and numerical information; ability to seek information to solve problems
* Ability to discuss complex issues in a trial and resolve them through explanation and persuasive skills
* Computer literate with Microsoft Office
* Vaccination status as required by OUH occupational health / NHS
* UK professional registration
* Desirable: MSc in a scientific/relevant area; NHS experience; aseptic experience; awareness of Good Clinical Practice legislation and standards; ability to adapt to change
Additional Information
Oxford University Hospitals NHS Foundation Trust is one of the largest NHS teaching trusts in the country and provides a wide range of clinical services, education, training and research. The Trust comprises four hospitals: John Radcliffe Hospital, Churchill Hospital, Nuffield Orthopaedic Centre and the Horton General Hospital.
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