Clinical Trial Pharmacy Technician

Cardiff and Vale University Health Board

Information:

This job is now closed

Job summary

At the University Hospital Wales, our patients are at the heart of everything we do.

Are you a registered Pharmacy Technician?

Do you have attention to detail and an interest in research?

Are you pro-active and ambitious about providing exceptional care and experience for patients?

Are you able to work independently in a concise, methodical way?

If the answer is yes, the Pharmacy Department is currently recruiting for a Clinical Trials Pharmacy Technician to join our clinical trials team based at the University Hospital of Wales.

We are looking for a dedicated individual who can demonstrate professional accountability to enhance patient care and who can provide maximum efficiency, safety and compliance to the Good Clinical Practices of the Health Board policies. All work is within Standard Operating Procedures (SOPs) and EU Good Manufacturing Practice legislation.

The post holder will support the clinical trials team with the role to include dispensing and checking clinical trial prescriptions for patients under the care of Cardiff and Vale UHB and to ensure the provision of a high quality, patient focused pharmaceutical service to both patients, research staff and external Sponsors.

You will work as part of a specialised, friendly team whilst also working independently using your own initiative to manage problems, enquiries and urgent requests, referring to the senior technician or a pharmacist if necessary.

Main duties of the job

The Post holder should have knowledge of Good Clinical Practice (GCP) and be able to apply and ensure the principles of GCP are adhered to in the management of clinical trials whilst maintaining accurate records of dispensing. Other duties include:

  1. To contribute to the provision of a dispensing service for clinical trial patients.
  2. Under the general direction of the supervising pharmacist and senior pharmacy technician to undertake the day to day management of the pharmacy clinical trials service ensuring an efficient and timely service to all users
  3. To undertake technical checking of prescriptions as an Accredited Checking Pharmacy Technician
  4. To write pharmacy procedures for the management of Investigational Medicinal Products
  5. To work as part of a team and also work independently and using own initiative to deal with problems, enquiries and urgent requests referring to the senior technician or a pharmacist if necessary.
  6. To liaise with CRAs during feasibility visits, Site Initiation visits, monitoring visits
  7. To assist with invoices for Clinical Trials
  8. To participate in the ordering, stock control, distribution and disposal of all items used within the clinical trials department

About us

Cardiff and Vale University Health Board is one of the largest Integrated Health Boards in the UK, employing over 15,000 staff, providing over 100 specialist services. Working across 6 hospital sites, we have a diverse range of career opportunities to offer. Serving around 500,000 people living in Cardiff and the Vale of Glamorgan, we are focussed on the health and care needs of our local population whilst working with our partners to develop regional services.

Our mission is "Caring for People, Keeping People Well",and our vision is that every person's chance of leading a healthy life should be equal. As an organisation we are unashamedly ambitious for our population's health, rising to the challenges of today and tomorrow through our 10-year strategy, Shaping our Future Wellbeing. We are contributing to a healthier Wales with great emphasis placed on innovation and improvement, learning from around the world and leading the way in clinical research. Partnership working is strong at Cardiff and Vale, and we work closely with our staff and our community.

Cardiff, the thriving Welsh capital, is a fantastic city to live and work in with an abundance of sports, arts and cultural attractions. Situated to the west of Cardiff, the Vale of Glamorgan offers a combination of beautiful Welsh countryside and a dramatic natural coastline. Whether city life or rural living, Cardiff and the Vale offers the best of both worlds.

Date posted

06 December 2023

Pay scheme

Agenda for change

Band

Band 5

Salary

£28,834 to £35,099 a year per annum pro rata

Contract

Permanent

Working pattern

Full-time

Reference number

001-PST130-1223

Job locations

University Hospital of Wales

Heath Park

Cardiff

CF11 9JP


Job description

Job responsibilities

DUTIES AND RESPONSIBILITIES

To dispense and check clinical trial prescriptions for patients under the care of Cardiff and Vale UHB and to ensure the provision of a high quality, patient focused pharmaceutical service to patients

  1. To contribute to the provision of a dispensing service for clinical trial patients. To apply and ensure the principles of GCP are adhered to in the management of clinical trials maintain records of dispensing including clinical trial material.
  2. Under the general direction of the supervising pharmacist and senior pharmacy technician to undertake the day to day management of the pharmacy clinical trials service ensuring an efficient and timely service to all users
  3. To undertake technical checking of prescriptions as an Accredited Checking Pharmacy Technician and to maintain competences and accreditation in this area.
  4. To write pharmacy procedures for the management of Investigational Medicinal Products using source documents such as the protocol and pharmacy manual
  5. To work as part of a team and also work independently and using own initiative to deal with problems, enquiries and urgent requests referring to the senior technician or a pharmacist if necessary.
  6. To provide administrative cover during periods of staff leave. This includes ordering and receiving of IMPs and administrative duties
  7. To liaise with CRAs during feasibility visits, Site Initiation visits, monitoring visits
  8. To assist with invoices for Clinical Trials
  9. To use professional judgement to make appropriate decisions based on evaluating facts and options e.g. supply problems with urgent items.
  10. To work within Standard Operating Procedures (SOPs) and EU Good Manufacturing Practice legislation and be guided by professional good practice guidelines.
  11. To act as an expert witness and provide training for those pharmacy staff undertaking NVQ level 2 and 3 pharmacy qualifications and act as a mentor for these staff
  12. To participate in the ordering, stock control, distribution and disposal of all items used within the clinical trials department
  13. To assist in the instruction and supervision of pharmacy assistants, pre-registration pharmacy technicians, pre-registration and diploma pharmacists and pharmacy students
  14. To participate in the induction and supervision of new pharmacy staff
  15. To participate in staff performance and appraisal schemes and contribute to the staff training sessions.
  16. To participate in staff rotas including if necessary early and late sessions, weekend and bank holidays.
  17. To participate in departmental audits and service improvement initiatives
  18. To deputise for the senior technician in clinical trials

Additionally, the post holder will:

  • Communicate with clinical and non-clinical staff and patients on complex topics such as medication using the written and spoken word.
  • Be a team player with a defined roles and responsibilities
  • Train pharmacy staff on all aspects relevant to their individual roles in clinical trials
  • Be a Registered pharmacy professional with the General Pharmaceutical Council
  • Have experience of working within a pharmacy including a variety of different aspects e.g. dispensary, ward top ups, aseptics and stores.
  • Good understanding and hands on experience of working with a variety of computer databases and systems.
  • Adhere to EU legislation-Good Clinical Practice (GCP) on a day to day basis.
  • Good comprehension of the English language to understand and apply instructions on prescriptions and dispensing guidelines accurately and reliably.
  • To be able to use own judgement consistently throughout day to determine which urgent tasks must next be completed to ensure patient and user satisfaction.
  • To know when to refer to senior colleague during interactions with patients and carers
  • Responds and manages changes in workflow priorities as the day develops.
  • Using clinical judgement to determine suitability of treatments based on defined patient parameters.
  • Prioritises own work load and that of other junior colleagues working within the same area
  • Ensure routine tasks are carried out within work area
  • Ability to work within tight time frames and under pressure within a busy environment.
  • Responds and manages changes in workflow priorities as the day develops
  • Skill to dispense complex medications and to undertake manipulations with accuracy and speed.
  • Keyboard skills to enter complex data on a variety of databases.
  • Lifting of bulky trial site files and deliveries of Investigational Products
  • Joint responsibility for the sessional management of their current work area.
  • Responsible for accurate dispensing of specialised medicines.
  • Advises medical and nursing staff on issues relating to medication regimes and changes to prescribing
  • Responsible for the technical accuracy of prescriptions dispensed by others and checked by self.
  • Gives advice to and educates patients and carers in the safe and effective use of their medicines
  • Works within standard operating procedures.
  • To actively participate in the continual improvement of the pharmacy service
  • Implement policies and propose changes to practices, procedures for own area
  • Implements SOPs within pharmacy technician teams
  • Suggests and participates in service development and improvement initiatives within the clinical trials service
  • Responsible for safe and effective use of expensive medicines and keeping wastage to a minimum
  • Ensures security of working area including drugs and IT equipment
  • Responsible for safe use and routine cleaning of expensive specialised equipment
  • Acts as a signatory for Controlled Drugs
  • Supervise and trains less experienced technicians, students, other staff; basic work based assessments.
  • Enters patient data onto pharmacy computer system.
  • Maintains records of drug usage in both the written word and on IT resources
  • Responsible for maintaining clinical trial records on a variety of databases.
  • Undertake accurate data entry using computerised and/or paper-based systems.
  • Ensure that the site files for the studies are maintained according to regulatory requirements and data is provided promptly.
  • Inputs and stores prescription data
  • Actively participates in and maintains near miss and incident recording
  • Dispenses for clinical trials as per SOPs and according to GCP requirements
  • Participates in departmental audits related to clinical trials
  • Works within SOPs, departmental policies, MHRA and GCP
  • Works independently, accredited to check dispensed prescriptions of others.
  • Standing/ walking most of the day.
  • Uses keyboard throughout day
  • Some lifting/ moving of loads, including A4 files, boxes containing CT drugs
  • Prolonged concentration required to undertake drug calculations and the intravenous dispensing of medication, accredited checking of prescriptions
  • Frequent interruptions to answer queries.
  • Deals with patients that may be upset or demanding.
  • Explains waiting times to patients and staff occasionally

Whilst ACT qualifications are required for this post, we welcome applicants who wish to work towards these qualifications and full training will be provided. During training the contract will be Annex 21: 75% of a Band 5 for up to 12 months until qualifications in both ACT and Medicines Management are achieved.

The ability to speak Welsh is desirable for this post; Welsh and/or English speakers are equally welcome to apply.

Job description

Job responsibilities

DUTIES AND RESPONSIBILITIES

To dispense and check clinical trial prescriptions for patients under the care of Cardiff and Vale UHB and to ensure the provision of a high quality, patient focused pharmaceutical service to patients

  1. To contribute to the provision of a dispensing service for clinical trial patients. To apply and ensure the principles of GCP are adhered to in the management of clinical trials maintain records of dispensing including clinical trial material.
  2. Under the general direction of the supervising pharmacist and senior pharmacy technician to undertake the day to day management of the pharmacy clinical trials service ensuring an efficient and timely service to all users
  3. To undertake technical checking of prescriptions as an Accredited Checking Pharmacy Technician and to maintain competences and accreditation in this area.
  4. To write pharmacy procedures for the management of Investigational Medicinal Products using source documents such as the protocol and pharmacy manual
  5. To work as part of a team and also work independently and using own initiative to deal with problems, enquiries and urgent requests referring to the senior technician or a pharmacist if necessary.
  6. To provide administrative cover during periods of staff leave. This includes ordering and receiving of IMPs and administrative duties
  7. To liaise with CRAs during feasibility visits, Site Initiation visits, monitoring visits
  8. To assist with invoices for Clinical Trials
  9. To use professional judgement to make appropriate decisions based on evaluating facts and options e.g. supply problems with urgent items.
  10. To work within Standard Operating Procedures (SOPs) and EU Good Manufacturing Practice legislation and be guided by professional good practice guidelines.
  11. To act as an expert witness and provide training for those pharmacy staff undertaking NVQ level 2 and 3 pharmacy qualifications and act as a mentor for these staff
  12. To participate in the ordering, stock control, distribution and disposal of all items used within the clinical trials department
  13. To assist in the instruction and supervision of pharmacy assistants, pre-registration pharmacy technicians, pre-registration and diploma pharmacists and pharmacy students
  14. To participate in the induction and supervision of new pharmacy staff
  15. To participate in staff performance and appraisal schemes and contribute to the staff training sessions.
  16. To participate in staff rotas including if necessary early and late sessions, weekend and bank holidays.
  17. To participate in departmental audits and service improvement initiatives
  18. To deputise for the senior technician in clinical trials

Additionally, the post holder will:

  • Communicate with clinical and non-clinical staff and patients on complex topics such as medication using the written and spoken word.
  • Be a team player with a defined roles and responsibilities
  • Train pharmacy staff on all aspects relevant to their individual roles in clinical trials
  • Be a Registered pharmacy professional with the General Pharmaceutical Council
  • Have experience of working within a pharmacy including a variety of different aspects e.g. dispensary, ward top ups, aseptics and stores.
  • Good understanding and hands on experience of working with a variety of computer databases and systems.
  • Adhere to EU legislation-Good Clinical Practice (GCP) on a day to day basis.
  • Good comprehension of the English language to understand and apply instructions on prescriptions and dispensing guidelines accurately and reliably.
  • To be able to use own judgement consistently throughout day to determine which urgent tasks must next be completed to ensure patient and user satisfaction.
  • To know when to refer to senior colleague during interactions with patients and carers
  • Responds and manages changes in workflow priorities as the day develops.
  • Using clinical judgement to determine suitability of treatments based on defined patient parameters.
  • Prioritises own work load and that of other junior colleagues working within the same area
  • Ensure routine tasks are carried out within work area
  • Ability to work within tight time frames and under pressure within a busy environment.
  • Responds and manages changes in workflow priorities as the day develops
  • Skill to dispense complex medications and to undertake manipulations with accuracy and speed.
  • Keyboard skills to enter complex data on a variety of databases.
  • Lifting of bulky trial site files and deliveries of Investigational Products
  • Joint responsibility for the sessional management of their current work area.
  • Responsible for accurate dispensing of specialised medicines.
  • Advises medical and nursing staff on issues relating to medication regimes and changes to prescribing
  • Responsible for the technical accuracy of prescriptions dispensed by others and checked by self.
  • Gives advice to and educates patients and carers in the safe and effective use of their medicines
  • Works within standard operating procedures.
  • To actively participate in the continual improvement of the pharmacy service
  • Implement policies and propose changes to practices, procedures for own area
  • Implements SOPs within pharmacy technician teams
  • Suggests and participates in service development and improvement initiatives within the clinical trials service
  • Responsible for safe and effective use of expensive medicines and keeping wastage to a minimum
  • Ensures security of working area including drugs and IT equipment
  • Responsible for safe use and routine cleaning of expensive specialised equipment
  • Acts as a signatory for Controlled Drugs
  • Supervise and trains less experienced technicians, students, other staff; basic work based assessments.
  • Enters patient data onto pharmacy computer system.
  • Maintains records of drug usage in both the written word and on IT resources
  • Responsible for maintaining clinical trial records on a variety of databases.
  • Undertake accurate data entry using computerised and/or paper-based systems.
  • Ensure that the site files for the studies are maintained according to regulatory requirements and data is provided promptly.
  • Inputs and stores prescription data
  • Actively participates in and maintains near miss and incident recording
  • Dispenses for clinical trials as per SOPs and according to GCP requirements
  • Participates in departmental audits related to clinical trials
  • Works within SOPs, departmental policies, MHRA and GCP
  • Works independently, accredited to check dispensed prescriptions of others.
  • Standing/ walking most of the day.
  • Uses keyboard throughout day
  • Some lifting/ moving of loads, including A4 files, boxes containing CT drugs
  • Prolonged concentration required to undertake drug calculations and the intravenous dispensing of medication, accredited checking of prescriptions
  • Frequent interruptions to answer queries.
  • Deals with patients that may be upset or demanding.
  • Explains waiting times to patients and staff occasionally

Whilst ACT qualifications are required for this post, we welcome applicants who wish to work towards these qualifications and full training will be provided. During training the contract will be Annex 21: 75% of a Band 5 for up to 12 months until qualifications in both ACT and Medicines Management are achieved.

The ability to speak Welsh is desirable for this post; Welsh and/or English speakers are equally welcome to apply.

Person Specification

Essential

Essential

  • Registered Pharmacy Technician
  • Knowledge of current medicines legislation

Desirable

  • Accredited accuracy checking technician
  • GCP experience

English

Essential

  • Computer literate (Microsoft Office-Word, Excel, PowerPoint)

English

Essential

  • Proven pharmacy experience

English

Essential

  • Ability to work as part of a team

Desirable

  • clinical trial dispensing experience
Person Specification

Essential

Essential

  • Registered Pharmacy Technician
  • Knowledge of current medicines legislation

Desirable

  • Accredited accuracy checking technician
  • GCP experience

English

Essential

  • Computer literate (Microsoft Office-Word, Excel, PowerPoint)

English

Essential

  • Proven pharmacy experience

English

Essential

  • Ability to work as part of a team

Desirable

  • clinical trial dispensing experience

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

Certificate of Sponsorship

Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).

From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).

UK Registration

Applicants must have current UK professional registration. For further information please see NHS Careers website (opens in a new window).

Additional information

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

Certificate of Sponsorship

Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).

From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).

UK Registration

Applicants must have current UK professional registration. For further information please see NHS Careers website (opens in a new window).

Employer details

Employer name

Cardiff and Vale University Health Board

Address

University Hospital of Wales

Heath Park

Cardiff

CF11 9JP


Employer's website

https://cavuhb.nhs.wales/ (Opens in a new tab)

Employer details

Employer name

Cardiff and Vale University Health Board

Address

University Hospital of Wales

Heath Park

Cardiff

CF11 9JP


Employer's website

https://cavuhb.nhs.wales/ (Opens in a new tab)

For questions about the job, contact:

Senior Clinical Trials Technician

Annie Rainey

annie.rainey@wales.nhs.uk

02921842991

Date posted

06 December 2023

Pay scheme

Agenda for change

Band

Band 5

Salary

£28,834 to £35,099 a year per annum pro rata

Contract

Permanent

Working pattern

Full-time

Reference number

001-PST130-1223

Job locations

University Hospital of Wales

Heath Park

Cardiff

CF11 9JP


Supporting documents

Privacy notice

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