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Clinical Trials Pharmacy Technician

Job details
Posting date: 04 February 2025
Salary: £44,806.00 to £53,134.00 per year
Additional salary information: £44806.00 - £53134.00 a year
Hours: Full time
Closing date: 18 February 2025
Location: London, SE5 8AZ
Company: NHS Jobs
Job type: Permanent
Job reference: C9334-25-0093

Summary

1. Assist in the day to day management of Clinical Trials (CT) at SLaM in conjunction with the CT Pharmacist and Technician team. Ensure that all CT files contain all the necessary documentation, are kept up to date and contain all relevant regulatory approvals. 2. Review prospective clinical trial prescription forms supplied by research organisations and assess suitability for use or required amendments before the trial commences and make recommendations for amendments. Review clinical trial protocols prior to approval, at SLaM assessing the suitability and safety relating to packaging, labelling, shipment, storage and dispensing of study medication and make recommendations for changes when appropriate. Ensure that processes and SOPs are in place for the accurate dispensing of CTs in relation to the above activities ensuring that they meet the required standard. 3. Write a clear synopsis for each clinical trial protocol for the Pharmacy Trial file. Prepare (and update as required) clear and accurate written dispensing procedures for dispensing staff for each clinical trial in accordance with the International Conference for Harmonisation for Good Clinical Practice (ICHGCP) and each study's protocol. 4. In conjunction with the CT Pharmacist review KHP overarching SOPs as requested. 5. Create drug accountability records, patient ID logs and other documents where the study sponsor has not provided them. Audit files regularly to ensure accurate completion of records and that files contain all required material and comply with current guidelines and legislation across SLaM pharmacies. Ensure there are 'codebreaking' procedures in place for drug treatments in case of emergency. Perform 'close down' for CTs and ensure that trial documents are archived as per SOPs. 6. Dispense and check CT medications ensuring each item is accurately dispensed and in the correct packaging, according to SOPs. Complete dispensing records, accurately recording batch numbers, expiry date and provide patient information according to each clinical trial. Perform the final accuracy check on dispensed IMPs, as an Accredited Checking Technician (ACT), according to SOPs. Organise the timely supply of medications to patients on wards and at home. Prioritise and delegate to other pharmacy team members as necessary and communicate any delays in supply to the appropriate person/team. 7. Manage the security and maintenance of all CT drugs from receipt, storage and return or destruction and ensure that the necessary documentation audit trail is present in accordance with all legal requirements and each study's protocol. Responsible for ensuring that storage conditions for IMPs are temperature monitored. Responsible for the maintenance of electronic and/or manual temperature records. Responsible for routine monitoring visits. To act as a pharmacy representative during trial audits and inspections. To act as a role model for pharmacy staff providing a clinical trials service, participate in departmental meetings to keep staff up to date with trial specific issues. Supervise dispensary staff to ensure that work is conducted to a high standard and in accordance with SOPs and ICH GCP. 8. To assist in the training of SLaM staff in relation to clinical trials. 9. To communicate regularly and arrange and participate in meetings with internal Investigators (senior physicians), research nurses and with trial organisers (monitors etc) in sponsoring organisations to establish and maintain a good working relationship and to provide a prompt and effective pharmacy clinical trials service. To ensure effective communication throughout the pharmacy service of any Clinical Trials developments and across the Trust as necessary. Counsel and provide information to patients, or their chosen representative on the use of their medications, offering advice, and answering queries within own remit and referring to the appropriate healthcare professional where appropriate. Act as a pharmacy contact at SLaM for CTs. 10. Responsible for monitoring the clinical trial income. Assist with providing pharmacy cost information to Investigators for grant applications for new studies and non-commercial trials. To assist in ensuring that commercial trials are charged for appropriate activity at the agreed NCVR rates. To ensure final pharmacy fees are submitted for commercial trials following close out. 11. Compile monthly dispensing figures to send to SLaM finance. Liaise with research teams and SLaM finance to invoice non-commercial trial pharmacy charges. 12. Assist with refurbishment planning for the CT Pharmacy and to take part/lead in other service improvement projects.