Pharmacy Technician Clinical Trials

Job overview

The importance of clinical research in the NHS is embedded in NUH Trust Objectives and long term strategy. The Trust Research and Innovation department recognise the vital role pharmacy has to play in the management of good quality clinical research.

You will be supporting the lead technicians in the delivery of clinical trials services for all studies open to recruitment on the City campus. This will include the dispensing of IMPs, accurate completion of accountability documentation, maintenance of pharmacy files and all aspects of IMP management.

Please refer to the job description and person specification attached to the advert for the full details of the vacancy.

Main duties of the job

To carry out pharmaceutical technical duties in the provision of pharmacy services in trials of Investigational Medicinal Products, ensuring compliance with standards of clinical trial management as outlined in NUH Trust Clinical Trials Policy, Guidelines for the Safe and Secure Handling of Medicines, relevant and applicable EU and UK legislation and the Research Governance Framework for Health and Social Care 2005.

You will need to be an enthusiastic and adaptable team player, with good written and verbal communication skills, and pay close attention to detail because this is essential for this role. You will be liaising closely with other members of the pharmacy clinical trials team and you will also be in contact with Trust and University of Nottingham research staff and representatives from pharmaceutical companies who sponsor clinical research conducted within the Trust.

The post holder will be based at City Campus and will be expected to rotate between campuses, as required by the needs of the service.

Working for our organisation

With over 19,000 staff, we are one of the biggest employers in the city with a central role in supporting the health and wellbeing of our local population. We play a leading role in research, education and innovation.

Come and join our wonderful team at NUH. We are big believers in diversity and welcome new ideas to help develop our team in order to deliver world class healthcare to the vast patient populations we serve. With endless personal development opportunities available, at NUH we will endeavour to turn your job into a career!

We particularly welcome applications from people who identify as Black, Asian and Minority Ethnic, or Disabled, as we are striving to be better represented at NUH

1. To successfully complete and maintain a dispensing validation. Accurately label, assemble prescribed items, dispense and perform in process self-checking of all medicines (including cytotoxic drugs) safely and in a timely fashion by following the clinical trial specific procedures.
2. Following successful completion of the dispensing validation programme, to then complete the accuracy checking validation for accurately checking of all investigational medicinal products in a timely manner for patients recruited into clinical trials.
3. To assist with co-ordinating of the dispensary and prioritise workload to ensure effective and responsive pharmacy service, identifying delays and working to minimise these.
4. To support the development of clinical and technical services provided by the pharmacy clinical trials team.
5. To provide technical support for the interpretation, dispensing and checking of clinical trials (after completion of training and validation in accuracy checking)
6. To support the planning and efficient processing of clinical trial prescriptions, prioritising according to urgency as required.
7. To assist in the appropriate, accurate and legible completion of Investigational Medicinal Products (IMPs) and Non Investigational Medicinal Products (NIMPs) accountability documentation
8. To assist in stock control and related issues for all medicines (including IMPs, NIMPs and medicines which become available under expanded access programmes) and any other materials required by the clinical trials service to maintain operation. This will include ordering and receipt, monitoring of stock levels and expiry dates and ensuring appropriate storage conditions.

• Order and receive stock via the Pharmacy computer system.
• Receive shipments of IMP via the IWRS sponsor system
• Receive and replenish stock orders from Pharmacy Stores.
• Identify, investigate and reconcile any stock discrepancies in a timely manner.
• Ensure stock is rotated and used in accordance with its expiry.
• Ensure that stock is maintained and managed, whilst minimising expenditure, stockholding and wastage.
• To participate in all stocktaking activities, ensuring procedures are followed to maintain accurate stock balances.

1. To successfully complete and maintain a shipment receipt validation of clinical trial materials from external suppliers, according to procedures.
2. To successfully complete and maintain destructions of IMP validations of clinical trial materials
3. To assist in the upkeep of dedicated clinical trials storage areas, including daily temperature control and monitoring.
4. To manage telephone and face to face enquiries from a wide range of staff groups and service users, resolving where possible and referring appropriate queries to relevant members of the trials team.
5. To support the preparation of proposed charges for pharmacy clinical trial services incurred in named protocols and the collation of information required for submission of invoices for goods or services.
6. To support the lead pharmacy technicians in assisting with the sponsor representative during their pharmacy monitoring visits
7. To assist with training and act as a role model to other members of technical and support staff providing the clinical trials service.
8. To attend team meetings and other events within the organisation, and to participate in taking comprehensive and accurate minutes.
9. To support and participate in preparation for and during clinical trial audit by sponsors and MHRA inspections
10. To assist with close-out preparations of studies that have finished with any pharmacy activities.
11. To deputise for Lead Technicians - Clinical Trials by acting as the lead in the operational management of the trials dispensary, where appropriate and when required. This includes co-ordinating the work in the trials dispensary and close liaison with the aseptic unit and trials technician within the unit to ensure timely delivery of trial IMPs for aseptic preparation.
12. To support the Lead Technicians and Trials Pharmacists in the maintenance of ongoing trials; duties to include arranging sponsor visits, overseeing sponsor representatives during visits and acting on sponsor requests in liaison with the Lead Technicians.
13. To maintain regular personal practice skills in dispensing, counselling patients on their medication, accuracy checking and the pharmacy computer system in the dispensary satellites. This will include the dispensing and safe handling of controlled drugs and cytotoxic medicines.
14. To undertake 2 yearly NIHR GCP training and complete NUH mandatory training
15. Hours to be worked over 7 days, as per local shifted and bank holiday duties: To participate in departmental weekend, bank holiday and late duty working as required. At the time of advertising, the weekend rota encompasses 2 half-day shifts every 4/5 weeks at the city campus or 1 full day shift every 4 weeks at the QMC campus. In addition, the post holder will participate in a system of flexible shifts to facilitate NUH pharmacy opening times.
16. To be adaptable to move from one work area to another at short notice in response to demands on the service
17. To participate as an appraisee in the departmental Personal Development Review (PDR) and work to achieve agreed set objectives

Person specification

Training and Qualifications

• BTEC, City and Guilds or NVQ level 3 in Pharmaceutical Services, or recognised equivalent.
• Current registration with the General Pharmaceutical Council (GPhC)

• Accredited accuracy checker (to successfully complete validation within 6 months of appointment).
• Additional training or supervisory qualification. Existing management and organisational skills

Experience

• Previous Pharmacy experience to include:
• Receiving and dispensing prescriptions
• Pharmacy electronic systems for labelling and stock management.
• Stock management
• Able to work in a productive team
• Able to work safely as an individual
• Awareness of pharmacy clinical trials services

• Experience in clinical trials services
• Evidence of understanding of extended technician roles

Communication and Relationships Skills

• Able to communicate clearly verbally and electronically within a multidisciplinary team
• Demonstrate that they are approachable and be able to relay information in a manner that others understand
• Respond in a positive manner to both positive and negative feedback and reflect on practice to make any necessary changes
• Act as a positive role model to junior staff

• Evidence of an ability to train colleagues and junior staff

Analytical and Judgment Skills

• Accurate with good attention to detail
• Able to follow instructions and standard operating procedures
• Able to work accurately and sustain concentration over short to long periods
• Able to work accurately and consistently whilst repeatedly dealing with interruptions
• Able to identify delays in work flow and actively work towards minimising these
• Able to identify and work within limits of own knowledge and responsibilities
• Able to accurately record simple and complex data across a variety of computer programs

• Have previously acted as a witness for those requiring evidenced based competency qualifications

Planning and Organisation Skills

• Able to work on own initiative and manage own time to meet deadlines
• Able to prioritise tasks in accordance with department and patient needs
• Demonstrate ability to multitask
• Methodical and well organised

• Demonstrate taking a key role in the organisation of a team or function e.g. previous pharmacy role, voluntary work

___________________________________________________________________________________

Come and join our wonderful team at NUH. We are big believers in diversity and welcome new ideas to help develop our team in order to deliver world class healthcare to the vast patient populations we serve. With endless personal development opportunities available, at the NUH we will endeavour to turn your job into a career!

We particularly welcome applications from people who identify as Black, Asian and Minority Ethnic, or Disabled, as we are striving to be better represented at NUH.

Applicants are kindly requested to refrain from using AI at any stage during the recruitment process.

Closing Dates: Please submit your application form as soon as possible to avoid disappointment; we reserve the right to close vacancies prior to the published closing date if we receive a sufficient number of completed application forms.

Communication: All communication related to your application will be via the email address you have provided. Please ensure you check your email account including your junk email regularly.

Easy read application: if you have a disability and find it difficult to complete our online application form, you can apply via our easy read application which you can find on the intranet https://www.nuh.nhs.uk/easy-read-job-application

NUH are now able to offer application completion support and interview preparation support. Please follow the link to book onto our sessions: Support for NUH Job Applications

If you are aged 16 or 17 and applying for a role that is more than 20 hours a week, please be aware that you will be asked to commence an Apprenticeship within the Trust alongside your role, as long as there is a suitable apprenticeship standard available. This is in line with the current guidance in England that whilst young people under the age of 18 can leave school (on the last Friday in June) they must then do one of the following:

• Stay in full-time education, for example at a college
• Start an Apprenticeship
• Spend 20 hours of more a week working or volunteering, while in part-time education or training

For more details visit; School leaving age - GOV.UK (www.gov.uk)

Disability Confidence: All applicants who have declared a disability and who meet the essential criteria for the post will be shortlisted.

At Risk of redundancy: NHS employees within the East Midlands who are ‘at risk’ of redundancy will be given a preferential interview where they meet the essential criteria of the person specification.

International Recruitment: If you are applying for a role with us from outside of the UK then please read the guidance on applying for a health or social care job in the UK from abroad.

The system will run a check against the key security features within your documentation. The system will provide us with an outcome of your check which will be stored securely on your personal file along with all other pre-employment check documentation.

Consent:

• Transfer of information: If I have previous NHS service - I consent to the transfer of my Electronic Staff Record (ESR) data between this and other NHS Trusts. I also consent to the Occupational Health Department confidentially accessing my occupational health records from my current or previous employer in order to check the status of my vaccinations, immunisations s and screening tests as relevant to the post. I understand this is an automated process and the information will only be used for these purposes prior to me taking up the position at NUH.
• Disclosure and Barring Service: Your post maybe subject to a DBS check which incur a cost dependent on the level of check required (£49.50 for enhanced and £21.50 for standard). I agree to reimburse Nottingham University Hospitals NHS Trust the cost of a Disclosure and Barring Service (DBS) check if it is required (by deduction from first month’s pay). Should I decide to withdraw from my job offer, I agree to reimburse Nottingham University Hospitals NHS Trust the cost of the DBS check undertaken by cheque or other agreed method.
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