Pharmacy Clinical Trials

3 weeks ago

Oxford, United Kingdom Oxford University Hospitals NHS Foundation Trust Full time

Pharmacy Clinical Trials (Health Science) Associate Practitioner - Band 4 - Permanent

Hello My name is Lina Joniak and I am a Clinical Trials Pharmacy Team Manager for the Clinical Trials Pharmacy team in Oxford and I'm very excited to share this new and exciting career opportunity with you.

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.

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.

Core Role - Clinical Trials

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.
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 Therapy
Clinical 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 worksheet

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