Pharmacy Clinical Trials (Health Science) Associate Practitioner

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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.
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 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 worksheets.