Higher Level Pharmacy Technician - Clinical Trials
| Posting date: | 23 April 2025 |
|---|---|
| Salary: | Not specified |
| Additional salary information: | £29,970 - £36,483 per annum |
| Hours: | Part time |
| Closing date: | 23 May 2025 |
| Location: | Huddersfield, HD3 3EA |
| Company: | Calderdale & Huddersfield NHS Foundation Trust |
| Job type: | Permanent |
| Job reference: | 7099913/372-FSS2762 |
Summary
A Vacancy at Calderdale and Huddersfield NHS Foundation Trust.
The post holder will be part of the Pharmacy team supporting both clinical trials and also medicines optimisation initiatives
Main duties include:
Contributing to the day-to-day delivery of the Pharmacy clinical Trials Service to ensure the safe and timely dispensing of clinical trial medication in accordance with Good Clinical Practice (GCP) and/or Good Manufacturing Practice (GMP) in the Pharmacy Clinical Trials Dispensary and Pharmacy Aseptic Unit
Supporting pharmacy and medicines cost improvement programme working with both pharmacy and clinical colleagues to ensure cost effective use of medication.
To work closely and liaise with Research staff, Clinical Trial Investigators and Sponsors in the set-up and maintenance of Clinical Trials involving Investigational Medicinal Products (CTIMPs)
Develop, review and revise policies, guidelines, and procedures regarding clinical trial services.
To work when required , as an accredited checking technician for both clinical trials medication and also general dispensary duties
To contribute to the general management, organisation and operation of the pharmaceutical services within the trust
To contribute and participate fully in all training and educational developments within the hospital especially those relating to clinical trials and medicines optimisation
Clinical Trials
To be responsible for the day-to day supervision of the pharmacy clinical trial service:
• Review clinical trial protocols prior to trust approval under the supervision of the senior pharmacy clinical trials technician, assessing the suitability and safety relating to packaging, labelling, shipment, storage and dispensing of study medication and make recommendations for changes when appropriate. Complete the clinical trial assessment form.
• Ensure that all pharmacy clinical trial files contain all necessary documentation and are kept up to date.
• Prepare (and update as required) clear and accurate written dispensing and checking procedures for dispensing staff for each clinical trial including aseptic trials in accordance with Good Clinical Practice (GCP) and each study’s protocol.
• Prepare (and update as required) a clear and accurate written summary of each clinical trial protocol.
• Create drug accountability records, patient I.D logs and other documents deemed necessary (where the study sponsor has not already provided).
• Review prospective clinical trial specific forms supplied by research organisations and assess suitability for use or require amendment before the trial commences and make recommendations for amendments.
• Work with the clinical trial senior pharmacy technician to ensure that all documentation is complete and IMP storage is acceptable in accordance with the expectations of the Sponsor and current legislation.
We employ more than 6,500 staff who deliver compassionate care from our two main hospitals, Calderdale Royal Hospital and Huddersfield Royal Infirmary as well as in community sites, health centres and in patients’ homes. We also are incredibly proud to have almost 150 volunteers here at CHFT.
We provide a range of services including urgent and emergency care; medical; surgical; maternity; gynaecology; critical care; children’s and young people’s services; end of life care and outpatient and diagnostic imaging services.
We provide community health services, including sexual health services in Calderdale from Calderdale Royal and local health centres. These include Todmorden Health Centre and Broad Street Plaza.
We continue to modernise and invest in our health services to build on our strong reputation. Foundation trusts are public leaders in improving quality in health services. They are part of the NHS – yet decisions about what they do and how they do it are driven by independent boards. Boards listen to their Council of Governors and respond to the needs of their members – patients, staff and the local community.
Foundation trusts provide what the health service wants, yet are also free to invest quickly in the changes to the local community needs, in striving to be the best, and in putting their patients first.
Clinical Trials
To be responsible for the day-to day supervision of the pharmacy clinical trial service:
• Review clinical trial protocols prior to trust approval under the supervision of the senior pharmacy clinical trials technician, assessing the suitability and safety relating to packaging, labelling, shipment, storage and dispensing of study medication and make recommendations for changes when appropriate. Complete the clinical trial assessment form.
• Ensure that all pharmacy clinical trial files contain all necessary documentation and are kept up to date.
• Prepare (and update as required) clear and accurate written dispensing and checking procedures for dispensing staff for each clinical trial including aseptic trials in accordance with Good Clinical Practice (GCP) and each study’s protocol.
• Prepare (and update as required) a clear and accurate written summary of each clinical trial protocol.
• Create drug accountability records, patient I.D logs and other documents deemed necessary (where the study sponsor has not already provided).
• Review prospective clinical trial specific forms supplied by research organisations and assess suitability for use or require amendment before the trial commences and make recommendations for amendments.
• Work with the clinical trial senior pharmacy technician to ensure that all documentation is complete and IMP storage is acceptable in accordance with the expectations of the Sponsor and current legislation.
• Ensure that all files contain copies of all relevant regulatory approvals.
• Assist in the audit of trial files regularly to ensure accurate completion of records and that files contain all required material and comply with current guidelines and legislation.
• Ensure that there are ‘code-breaking’ procedures in place for drug treatment in cases of emergency.
• Assist in the management of all clinical trial supplies including ordering, receipt, storage and destruction/return in accordance with Sponsors requirements and local/national guidance.
• Report any temperature excursions, as per the reporting procedure in the clinical trial protocol or pharmacy manual, to each of the sponsors affected for advice and/or replacement IMP.
• Assist clinical research associates to perform close-down procedures for clinical trials.
• Communicate regularly 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 clinical trial service.
• Prepare for monitoring visits ensuring all accountability logs, investigational medicinal product and temperature logs are complete and ready for inspection.
• Update pharmacy site files as new information is received and ensure that relevant staff are made aware of any changes relevant to pharmacy.
• Dispensing clinical trials:• Review prescriptions on arrival at pharmacy for dispensing according to SOPs and escalate errors and omissions appropriately.
• Prepare labels ensuring that they meet the required standard.
• Dispense clinical trial medications ensuring each item is accurately dispensed, and in the correct packaging, according to standard operating procedures (SOPs) and trial protocols.
• Complete dispensing records, accurately recording batch numbers, expiry dates and patient information according to each clinical trial protocol.
• Perform the final accuracy check on dispensed on dispensed clinical trials, on completion of Accredited Checking Technician course, according to SOPs.
• Organise the timely supply of medications to patients. Prioritise and delegate to other pharmacy team members as necessary.
• Communicate any delays in supply to the appropriate person.
• Manage the security and maintenance of all clinical trial drugs from receipt, storage and return or destruction and to ensure that the necessary documented audit trail is in place in accordance with all legal requirements and each study protocol.
• Develop, write, review and implement standard operating procedures (SOPs) for clinical trial services and maintain a robust catalogue system with regards to distribution and recall of such SOPs within Pharmacy and for other service users.
Medicines Optimisation
· Working with lead pharmacist for procurement and directorate pharmacists, supporting on medicines optimisation initiatives and cost improvement programme
· To assist in identifying medicines savings opportunities
· To assist in educating members of both pharmacy and clinical teams in medication savings opportunities and required actions.
· To assist in monitoring/audit of medication savings
· To assist in presenting of medicines optimisation audit data to both pharmacy and clinical teams
This advert closes on Sunday 4 May 2025
The post holder will be part of the Pharmacy team supporting both clinical trials and also medicines optimisation initiatives
Main duties include:
Contributing to the day-to-day delivery of the Pharmacy clinical Trials Service to ensure the safe and timely dispensing of clinical trial medication in accordance with Good Clinical Practice (GCP) and/or Good Manufacturing Practice (GMP) in the Pharmacy Clinical Trials Dispensary and Pharmacy Aseptic Unit
Supporting pharmacy and medicines cost improvement programme working with both pharmacy and clinical colleagues to ensure cost effective use of medication.
To work closely and liaise with Research staff, Clinical Trial Investigators and Sponsors in the set-up and maintenance of Clinical Trials involving Investigational Medicinal Products (CTIMPs)
Develop, review and revise policies, guidelines, and procedures regarding clinical trial services.
To work when required , as an accredited checking technician for both clinical trials medication and also general dispensary duties
To contribute to the general management, organisation and operation of the pharmaceutical services within the trust
To contribute and participate fully in all training and educational developments within the hospital especially those relating to clinical trials and medicines optimisation
Clinical Trials
To be responsible for the day-to day supervision of the pharmacy clinical trial service:
• Review clinical trial protocols prior to trust approval under the supervision of the senior pharmacy clinical trials technician, assessing the suitability and safety relating to packaging, labelling, shipment, storage and dispensing of study medication and make recommendations for changes when appropriate. Complete the clinical trial assessment form.
• Ensure that all pharmacy clinical trial files contain all necessary documentation and are kept up to date.
• Prepare (and update as required) clear and accurate written dispensing and checking procedures for dispensing staff for each clinical trial including aseptic trials in accordance with Good Clinical Practice (GCP) and each study’s protocol.
• Prepare (and update as required) a clear and accurate written summary of each clinical trial protocol.
• Create drug accountability records, patient I.D logs and other documents deemed necessary (where the study sponsor has not already provided).
• Review prospective clinical trial specific forms supplied by research organisations and assess suitability for use or require amendment before the trial commences and make recommendations for amendments.
• Work with the clinical trial senior pharmacy technician to ensure that all documentation is complete and IMP storage is acceptable in accordance with the expectations of the Sponsor and current legislation.
We employ more than 6,500 staff who deliver compassionate care from our two main hospitals, Calderdale Royal Hospital and Huddersfield Royal Infirmary as well as in community sites, health centres and in patients’ homes. We also are incredibly proud to have almost 150 volunteers here at CHFT.
We provide a range of services including urgent and emergency care; medical; surgical; maternity; gynaecology; critical care; children’s and young people’s services; end of life care and outpatient and diagnostic imaging services.
We provide community health services, including sexual health services in Calderdale from Calderdale Royal and local health centres. These include Todmorden Health Centre and Broad Street Plaza.
We continue to modernise and invest in our health services to build on our strong reputation. Foundation trusts are public leaders in improving quality in health services. They are part of the NHS – yet decisions about what they do and how they do it are driven by independent boards. Boards listen to their Council of Governors and respond to the needs of their members – patients, staff and the local community.
Foundation trusts provide what the health service wants, yet are also free to invest quickly in the changes to the local community needs, in striving to be the best, and in putting their patients first.
Clinical Trials
To be responsible for the day-to day supervision of the pharmacy clinical trial service:
• Review clinical trial protocols prior to trust approval under the supervision of the senior pharmacy clinical trials technician, assessing the suitability and safety relating to packaging, labelling, shipment, storage and dispensing of study medication and make recommendations for changes when appropriate. Complete the clinical trial assessment form.
• Ensure that all pharmacy clinical trial files contain all necessary documentation and are kept up to date.
• Prepare (and update as required) clear and accurate written dispensing and checking procedures for dispensing staff for each clinical trial including aseptic trials in accordance with Good Clinical Practice (GCP) and each study’s protocol.
• Prepare (and update as required) a clear and accurate written summary of each clinical trial protocol.
• Create drug accountability records, patient I.D logs and other documents deemed necessary (where the study sponsor has not already provided).
• Review prospective clinical trial specific forms supplied by research organisations and assess suitability for use or require amendment before the trial commences and make recommendations for amendments.
• Work with the clinical trial senior pharmacy technician to ensure that all documentation is complete and IMP storage is acceptable in accordance with the expectations of the Sponsor and current legislation.
• Ensure that all files contain copies of all relevant regulatory approvals.
• Assist in the audit of trial files regularly to ensure accurate completion of records and that files contain all required material and comply with current guidelines and legislation.
• Ensure that there are ‘code-breaking’ procedures in place for drug treatment in cases of emergency.
• Assist in the management of all clinical trial supplies including ordering, receipt, storage and destruction/return in accordance with Sponsors requirements and local/national guidance.
• Report any temperature excursions, as per the reporting procedure in the clinical trial protocol or pharmacy manual, to each of the sponsors affected for advice and/or replacement IMP.
• Assist clinical research associates to perform close-down procedures for clinical trials.
• Communicate regularly 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 clinical trial service.
• Prepare for monitoring visits ensuring all accountability logs, investigational medicinal product and temperature logs are complete and ready for inspection.
• Update pharmacy site files as new information is received and ensure that relevant staff are made aware of any changes relevant to pharmacy.
• Dispensing clinical trials:• Review prescriptions on arrival at pharmacy for dispensing according to SOPs and escalate errors and omissions appropriately.
• Prepare labels ensuring that they meet the required standard.
• Dispense clinical trial medications ensuring each item is accurately dispensed, and in the correct packaging, according to standard operating procedures (SOPs) and trial protocols.
• Complete dispensing records, accurately recording batch numbers, expiry dates and patient information according to each clinical trial protocol.
• Perform the final accuracy check on dispensed on dispensed clinical trials, on completion of Accredited Checking Technician course, according to SOPs.
• Organise the timely supply of medications to patients. Prioritise and delegate to other pharmacy team members as necessary.
• Communicate any delays in supply to the appropriate person.
• Manage the security and maintenance of all clinical trial drugs from receipt, storage and return or destruction and to ensure that the necessary documented audit trail is in place in accordance with all legal requirements and each study protocol.
• Develop, write, review and implement standard operating procedures (SOPs) for clinical trial services and maintain a robust catalogue system with regards to distribution and recall of such SOPs within Pharmacy and for other service users.
Medicines Optimisation
· Working with lead pharmacist for procurement and directorate pharmacists, supporting on medicines optimisation initiatives and cost improvement programme
· To assist in identifying medicines savings opportunities
· To assist in educating members of both pharmacy and clinical teams in medication savings opportunities and required actions.
· To assist in monitoring/audit of medication savings
· To assist in presenting of medicines optimisation audit data to both pharmacy and clinical teams
This advert closes on Sunday 4 May 2025
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