Higher Level Pharmacy Technician - Clinical Trials
Calderdale and Huddersfield NHS Foundation Trust (CHFT) are committed to equal opportunities and welcome applications from all sections of the community, regardless of any protected characteristics.
We are committed to recruiting to our values. Leading One Culture of Care underpins our values by creating an environment, tone and behaviours across all parts of the Trust that are fundamentally rooted in compassionate care.
We are open to considering a wide range of flexible working arrangements. There are opportunities to flex the days of the week, hours and times of work and place of work including: part-time, job-share, flexible working hours and the possibility to work from home when appropriate.Please talk to us during the interview process to discuss any flexibility that you may require.
We received our Silver Award from the Defence Employer Recognition Scheme which is helping actively promote SaBRE - Supporting Britain’s Reservists and Employers. This means that we provided its statement of intent to support all Defence personnel and we welcome application to work for us.Find out more - Why Choose CHFT?
Our Future Plans
The Department of Health and Social Care has awarded capital funding to invest in local health services at both Calderdale Royal Hospital and Huddersfield Royal Infirmary. This is a significant investment and an opportunity to enhance services for our populations in Calderdale and Huddersfield and West Yorkshire for generations to come.To find out more, please visit https://future.cht.nhs.uk/
Job overview
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
Main duties of the job
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.
Working for our organisation
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.
Detailed job description and main responsibilities
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.
- 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
Person specification
QUALIFICATIONS / TRAINING
Essential criteria- Registered with the General Pharmaceutical Council (GPhC) as a Pharmacy Technician
- BTEC and NVQ Level 3 in Pharmaceutical Sciences or equivalent registerable qualification
- Accuracy checking qualification or willing to work towards accreditation
- Good Clinical Practice Training
KNOWLEDGE, EXPERIENCE & EXPERTISE
Essential criteria- Relevant dispensary experience as a Pharmacy Technician
- Experience of managing own time and workload
- Good communication skills – verbal and written/electronic
- Good organisational skills
- Computer literate
- Attention to detail with a high degree of accuracy
- Experience of Clinical Trials and the management of Investigational Medicinal Products
- Experience in writing Standard Operating Procedures (SOPs)
- Experience of Audit
- Experience in supervising other technicians and support staff.
- Hospital experience
COMMUNICATION AND RELATIONSHIPS (INCLUDING MANAGEMENT RESPONSIBILITIES)
Essential criteria- Able to work under pressure and meet targets. Is an independent worker
- Able to work with other senior staff and other healthcare professionals
- Good team worker
- Shows initiative and ‘self-starter’
- Methodical and accurate worker
- Always demonstrates professionalism
- Compassion, Accountability, Respect and Excellence
- Motivation and leadership skills
We take pride in the diversity of our workforce that’s why we encourage applications from all. Reasonable adjustments will be made for disabled applicants.
Please ensure your application is submitted with referees who can verify your employment/education history over the last three years and include valid email addresses for them. We will request electronic Factual Employment References from your previous employers.These references will be requested before you are issued with an unconditional offer of employment letter.
If you are appointed to a post, information will also be transferred into the NHS Electronic Staff Records system. The Inter-Authority Transfer (IAT) process is a critical and beneficial component of ESR and following interview your previous NHS employment data, if applicable will be transferred from your current / most recent employer.
You may be required to undertake a DBS. The Trust will administer the DBS check on your behalf and will recover the cost (Enhanced £54.40, Standard £26.40 or Basic £26.40) from your salary when you commence in post (including Internal staff).You will also be required to participate in the DBS Update Service and pay the £16 cost per year. This is a condition of your employment.
CHFT is part of the West Yorkshire Association of Acute Trusts (WYAAT), a collaborative of the NHS hospital trusts from across West Yorkshire and Harrogate working together to provide the best possible care for our patients.
If you have any questions please contact [email protected] for assistance.