Job summary
We are recruiting a Band 5 Pharmacy Technician to join our Clinical Trials Pharmacy team at Russells Hall Hospital, part of The Dudley Group NHS Foundation Trust. This is an exciting opportunity to work in a highly specialised area of pharmacy, supporting the delivery of academic and commercial clinical trials across dispensary and aseptic services.
You will work closely with senior pharmacists, senior technicians, research nurses and the Research and Innovation Department to support the safe and timely preparation, dispensing and management of clinical trial medicines. The role involves working to GCP and GMP standards, supporting trial set-up and maintenance, and helping ensure high quality pharmacy support for research studies.
This post is ideal for an organised, motivated pharmacy technician who is interested in developing specialist skills in clinical trials, aseptics and research pharmacy.
The Dudley Group has a strong reputation for innovation, quality improvement and research delivery. You will be part of a small, friendly and supportive clinical trials pharmacy team with strong links to Research and Development and the wider multidisciplinary team.
Main duties of the job
As a Pharmacy Technician within the Clinical Trials Pharmacy team, you will play a key role in supporting the safe and efficient delivery of clinical trials across dispensary and aseptic services. Your main duties will include:
- Supporting the preparation, dispensing and management of clinical trial medicines in line with trial protocols, GCP and GMP requirements
- Assisting with the set-up, ongoing management and close-down of academic and commercial clinical trials
- Liaising closely with the Pharmacy Department, Research and Innovation (R&I) Department to support coordinated delivery of clinical trials
- Working with pharmacists, other pharmacy colleagues, research nurses, clinicians, trial coordinators and external sponsors to support trial activity
- Supporting stock management for clinical trial medicines, including ordering, receipt, storage, expiry checks and temperature monitoring
- Maintaining accurate documentation and records in line with regulatory and governance requirements
- Supporting aseptic and non-sterile preparation of clinical trial products, in accordance with local procedures and training
- Assisting with internal audits, inspections and quality assurance activities related to clinical trials
- Providing support to dispensary and preparative services to ensure timely supply of clinical trial medicines
- Supporting training and guidance for pharmacy staff in relation to clinical trials processes and compliance
About us
At the Dudley Group our patients and staff are at the heart of all that we do and that is to provide a world class service that aligns with our vision of "excellent health care, improved health for all". We are seeking to recruit staff who share our vision and values of making Dudley Group an incredible workplace.
As part of the NHS People Promise, your wellbeing is our priority, and we are committed to ensuring our employees achieve a healthy work-life balance supported by our flexible working options and by making reasonable adjustments where possible. We believe no-one should have to sacrifice family, friends, or their personal interests for work. We are a modern employer able to attract and retain high quality staff through our commitment to the NHS People Promise.
As an employer, we foster an inclusive environment where everyone feels valued, supported, and empowered to contribute their best. We want to ensure that our workforce is representative of the population we serve. More information - inclusive practice people promise.
Dudley Group offer many opportunities for our staff to develop and grow within their roles through our Learning & OD Team. These include topics such as communication, wellbeing, team development, cultural competency, and values.
Please click below to view our EDI page: Equality, Diversity, and Inclusion - The Dudley Group NHS Foundation Trust (dgft.nhs.uk)
Job description
Job responsibilities
Job Summary
The purpose of this post is to undertake a wide range of technical duties in accordance with Standard Operating Procedures to support the delivery of pharmacy services. The post holder will support the provision of Clinical Trials across both the aseptic unit and the dispensary, in line with service needs. Occasional cover in other areas may be required. This post includes late night and weekend working on a rota basis, as the pharmacy provides a 7 day service.
The post holder will support the preparation, dispensing, monitoring and management of academic and commercial clinical trials at The Dudley Group NHS Foundation Trust. The role requires close working with the Pharmacy Department, Research and Innovation (R&I) Department, Research Delivery Network and multidisciplinary research teams to ensure high quality, compliant pharmacy support for clinical research.
Principal Duties and Responsibilities
Clinical Trials Responsibilities
- Support and aid the preparation, dispensing, monitoring and management of academic and commercial clinical trials
- Liaise with clinical trials research teams, external trial coordinators and pharmacy staff to ensure pharmacy aspects of clinical trials are carried out in accordance with the Medicines for Human Use (Clinical Trials) Regulations 2004, ICH Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP)
- Work with senior technicians and pharmacists to support service development and the education and development of pharmacy staff in clinical trials
- Facilitate pharmacy aspects of clinical trials by working with the Trust Research and Innovation Department, Research Nurses, Pharmacy Teams and commercial sponsors
- Work closely with the pharmacy clinical trials team, R&I Department and Research Delivery Network to review protocols and identify operational and financial implications of clinical trials
- Ensure clinical trials are reviewed and prioritised from a pharmacy perspective according to service need
- Ensure pharmacy procedures, trial specific documentation and computer dispensing systems are in place prior to first patient recruitment
- Participate in the set up, ongoing management and close down of clinical trials
- Prepare, update and advise staff on SOPs and trial protocols, ensuring safe and accurate dispensing and adherence to trial requirements
- Ensure safe dispensing of clinical trial medicines in accordance with protocols, GCP, GMP, European Directives and departmental procedures
- Support the dispensary with processing of clinical trial prescriptions and preparative services with manufacture of chemotherapy
- Assist with dispensing, preparation, reconstitution and recording of clinical trial products
- Support record keeping, archiving and maintenance of study documentation in line with regulatory and governance requirements
- Ensure stock checks, expiry date checks and temperature monitoring for clinical trial materials are carried out in line with procedures and audit requirements
- Order, receive and replenish clinical trial stocks in line with protocol requirements
- Support data collection for internal audits and quality monitoring
- Support risk assessments for clinical trials and escalate risks as appropriate
- Ensure the clinical trials area remains tidy, clean and professional in line with health and safety requirements
- Attend Research Network meetings and training as required
Service Delivery Responsibilities
- Support both dispensary and preparative services in line with service demand to ensure timely preparation and dispensing of clinical trials
- Provide deputation for Senior Clinical Trials Technicians during periods of service need
- Assist senior technicians with training of new staff on an ongoing basis
- Develop and coordinate links with the Trust Research and Innovation Department and Research Delivery Network
- Assist the Pharmacy Clinical Trials Team in contributing to Trust working groups in relation to clinical trial medicines
- Assist with preparation and implementation of SOPs and clinical trial documentation to ensure consistently high standards, including:
- Maintaining storage condition and expiry records
- Maintaining efficient stock control and accountability logs
- Maintaining clinical trial files and electronic and paper records
- Use of multiple clinical trial ordering systems
- Reporting stock discrepancies and ordering problems to senior staff
- Ensuring appropriate storage, stock rotation and disposal of expired stock
- Ensuring all documentation is completed accurately
Cancer and Preparative Services
- Work under the direction of senior pharmacists and technicians to ensure safe, timely and cost effective supply of products
- Prepare, monitor and check non sterile and aseptically prepared products in line with approved protocols
- Participate in and, where required, supervise aseptic preparation of products within the aseptic and cytotoxic unit, including cytotoxic products, monoclonals and intravenous additions
- Provide accredited pre and in process accuracy checking, where qualified
- Provide technical advice on time implications of manipulating and dispensing clinical trial and other drug products
- Maintain personal aseptic validation and undertake required training and reassessment
- Complete and file all relevant documentation
- Maintain stock control procedures and use computer systems to provide audit and financial information
- Assist with training of new staff and students
- Undertake team leader responsibilities within aseptic services when required
- Support internal audits and self inspection
- Support maintenance of pharmacy IT systems including creation of new items, procedures and techniques
- Ensure compliance with Trust procedures for prescribing and supply of intrathecal chemotherapy
- Advise pharmacy staff on safe storage and preparation of cytotoxic drugs
Dispensary Responsibilities
- Work under the direction of senior technicians and provide team leader duties when senior technicians are unavailable
- Dispense inpatient, outpatient and discharge medicines, including clinical trial prescriptions
- Counsel patients on medicines and refer to pharmacists for further advice where required
- Dispense controlled drugs under appropriate supervision and authorisation
- Supply stock to wards, departments, other hospitals and local authority clinics
- Provide dispensing accuracy checks as an accredited checking technician, where qualified
- Ensure prescription charges and sales are processed in line with Trust financial procedures
- Issue controlled stationery including prescriptions and requisition books
- Ensure prescriptions are accurately filed and archived
Budget Management and Audit Responsibilities
- Liaise with the Pharmacy Clinical Trials Team, R&I and Research Delivery Network to support drug reimbursement for clinical trials
- Support senior technicians and pharmacists with invoice queries and KPI data collection
- Conduct internal audits of pharmacy clinical trials
- Assist with production of activity and drug usage reports
- Identify and escalate potential cost reduction and efficiency initiatives
Training Responsibilities
- Support and participate in delivery of training for pharmacy staff related to clinical trials
- Deliver teaching sessions for staff relating to trials being opened or amended
- Support staff undertaking NVQ training
- Review available training for pharmacy support staff
- Contribute to development of training programmes for new support staff roles
People Management and Professional Responsibilities
- Comply with all Trust policies and procedures
- Comply with the Professional Code of Ethics for Pharmacy Technicians
- Deputise for senior technicians when requested
- Comply with GPhC Standards of Conduct, Ethics and Performance and CPD requirements
Risk Management, Health and Safety
- Minimise hazards and report risks in line with Trust procedures
- Adhere to safe systems of work
- Maintain high levels of accuracy and concentration in technical activities
- Refer medicines related problems to a pharmacist as appropriate
- Follow spillage procedures and act appropriately in the event of a spillage
- Highlight issues with SOPs to pharmacy team leaders
Administrative and Clerical Responsibilities
- Order and receipt goods in line with Trust financial framework with full audit trails
- Maintain confidentiality of patient and staff information
- Maintain COSHH governed product information and ensure it is kept up to date
- Use pharmacy computer systems to ensure accurate costings and audit trails
- Maintain records in line with local SOPs
- Support induction of new starters, work experience and training staff
- Ensure documentation is filed, archived and retained in line with legal requirements
Personal Development
- Work towards an agreed personal development plan through annual appraisal
- Apply CPD principles including reflective learning and personal development planning
- Maintain professional knowledge and awareness of Trust wide issues and trends
- Provide evidence of CPD activity during annual appraisal
The post holder may be required to undertake other duties consistent with the level and responsibilities of the role. This job description may be reviewed and amended in consultation with the post holder in line with service developments.
Job description
Job responsibilities
Job Summary
The purpose of this post is to undertake a wide range of technical duties in accordance with Standard Operating Procedures to support the delivery of pharmacy services. The post holder will support the provision of Clinical Trials across both the aseptic unit and the dispensary, in line with service needs. Occasional cover in other areas may be required. This post includes late night and weekend working on a rota basis, as the pharmacy provides a 7 day service.
The post holder will support the preparation, dispensing, monitoring and management of academic and commercial clinical trials at The Dudley Group NHS Foundation Trust. The role requires close working with the Pharmacy Department, Research and Innovation (R&I) Department, Research Delivery Network and multidisciplinary research teams to ensure high quality, compliant pharmacy support for clinical research.
Principal Duties and Responsibilities
Clinical Trials Responsibilities
- Support and aid the preparation, dispensing, monitoring and management of academic and commercial clinical trials
- Liaise with clinical trials research teams, external trial coordinators and pharmacy staff to ensure pharmacy aspects of clinical trials are carried out in accordance with the Medicines for Human Use (Clinical Trials) Regulations 2004, ICH Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP)
- Work with senior technicians and pharmacists to support service development and the education and development of pharmacy staff in clinical trials
- Facilitate pharmacy aspects of clinical trials by working with the Trust Research and Innovation Department, Research Nurses, Pharmacy Teams and commercial sponsors
- Work closely with the pharmacy clinical trials team, R&I Department and Research Delivery Network to review protocols and identify operational and financial implications of clinical trials
- Ensure clinical trials are reviewed and prioritised from a pharmacy perspective according to service need
- Ensure pharmacy procedures, trial specific documentation and computer dispensing systems are in place prior to first patient recruitment
- Participate in the set up, ongoing management and close down of clinical trials
- Prepare, update and advise staff on SOPs and trial protocols, ensuring safe and accurate dispensing and adherence to trial requirements
- Ensure safe dispensing of clinical trial medicines in accordance with protocols, GCP, GMP, European Directives and departmental procedures
- Support the dispensary with processing of clinical trial prescriptions and preparative services with manufacture of chemotherapy
- Assist with dispensing, preparation, reconstitution and recording of clinical trial products
- Support record keeping, archiving and maintenance of study documentation in line with regulatory and governance requirements
- Ensure stock checks, expiry date checks and temperature monitoring for clinical trial materials are carried out in line with procedures and audit requirements
- Order, receive and replenish clinical trial stocks in line with protocol requirements
- Support data collection for internal audits and quality monitoring
- Support risk assessments for clinical trials and escalate risks as appropriate
- Ensure the clinical trials area remains tidy, clean and professional in line with health and safety requirements
- Attend Research Network meetings and training as required
Service Delivery Responsibilities
- Support both dispensary and preparative services in line with service demand to ensure timely preparation and dispensing of clinical trials
- Provide deputation for Senior Clinical Trials Technicians during periods of service need
- Assist senior technicians with training of new staff on an ongoing basis
- Develop and coordinate links with the Trust Research and Innovation Department and Research Delivery Network
- Assist the Pharmacy Clinical Trials Team in contributing to Trust working groups in relation to clinical trial medicines
- Assist with preparation and implementation of SOPs and clinical trial documentation to ensure consistently high standards, including:
- Maintaining storage condition and expiry records
- Maintaining efficient stock control and accountability logs
- Maintaining clinical trial files and electronic and paper records
- Use of multiple clinical trial ordering systems
- Reporting stock discrepancies and ordering problems to senior staff
- Ensuring appropriate storage, stock rotation and disposal of expired stock
- Ensuring all documentation is completed accurately
Cancer and Preparative Services
- Work under the direction of senior pharmacists and technicians to ensure safe, timely and cost effective supply of products
- Prepare, monitor and check non sterile and aseptically prepared products in line with approved protocols
- Participate in and, where required, supervise aseptic preparation of products within the aseptic and cytotoxic unit, including cytotoxic products, monoclonals and intravenous additions
- Provide accredited pre and in process accuracy checking, where qualified
- Provide technical advice on time implications of manipulating and dispensing clinical trial and other drug products
- Maintain personal aseptic validation and undertake required training and reassessment
- Complete and file all relevant documentation
- Maintain stock control procedures and use computer systems to provide audit and financial information
- Assist with training of new staff and students
- Undertake team leader responsibilities within aseptic services when required
- Support internal audits and self inspection
- Support maintenance of pharmacy IT systems including creation of new items, procedures and techniques
- Ensure compliance with Trust procedures for prescribing and supply of intrathecal chemotherapy
- Advise pharmacy staff on safe storage and preparation of cytotoxic drugs
Dispensary Responsibilities
- Work under the direction of senior technicians and provide team leader duties when senior technicians are unavailable
- Dispense inpatient, outpatient and discharge medicines, including clinical trial prescriptions
- Counsel patients on medicines and refer to pharmacists for further advice where required
- Dispense controlled drugs under appropriate supervision and authorisation
- Supply stock to wards, departments, other hospitals and local authority clinics
- Provide dispensing accuracy checks as an accredited checking technician, where qualified
- Ensure prescription charges and sales are processed in line with Trust financial procedures
- Issue controlled stationery including prescriptions and requisition books
- Ensure prescriptions are accurately filed and archived
Budget Management and Audit Responsibilities
- Liaise with the Pharmacy Clinical Trials Team, R&I and Research Delivery Network to support drug reimbursement for clinical trials
- Support senior technicians and pharmacists with invoice queries and KPI data collection
- Conduct internal audits of pharmacy clinical trials
- Assist with production of activity and drug usage reports
- Identify and escalate potential cost reduction and efficiency initiatives
Training Responsibilities
- Support and participate in delivery of training for pharmacy staff related to clinical trials
- Deliver teaching sessions for staff relating to trials being opened or amended
- Support staff undertaking NVQ training
- Review available training for pharmacy support staff
- Contribute to development of training programmes for new support staff roles
People Management and Professional Responsibilities
- Comply with all Trust policies and procedures
- Comply with the Professional Code of Ethics for Pharmacy Technicians
- Deputise for senior technicians when requested
- Comply with GPhC Standards of Conduct, Ethics and Performance and CPD requirements
Risk Management, Health and Safety
- Minimise hazards and report risks in line with Trust procedures
- Adhere to safe systems of work
- Maintain high levels of accuracy and concentration in technical activities
- Refer medicines related problems to a pharmacist as appropriate
- Follow spillage procedures and act appropriately in the event of a spillage
- Highlight issues with SOPs to pharmacy team leaders
Administrative and Clerical Responsibilities
- Order and receipt goods in line with Trust financial framework with full audit trails
- Maintain confidentiality of patient and staff information
- Maintain COSHH governed product information and ensure it is kept up to date
- Use pharmacy computer systems to ensure accurate costings and audit trails
- Maintain records in line with local SOPs
- Support induction of new starters, work experience and training staff
- Ensure documentation is filed, archived and retained in line with legal requirements
Personal Development
- Work towards an agreed personal development plan through annual appraisal
- Apply CPD principles including reflective learning and personal development planning
- Maintain professional knowledge and awareness of Trust wide issues and trends
- Provide evidence of CPD activity during annual appraisal
The post holder may be required to undertake other duties consistent with the level and responsibilities of the role. This job description may be reviewed and amended in consultation with the post holder in line with service developments.
Person Specification
Qualifications
Essential
- Registered technician with the General Pharmaceutical Council
Qualifications
Desirable
- Recognised, current Accredited Checking Technician qualification.
Experience
Essential
- Post qualification experience in hospital pharmacy.
- IT literate - use of databases, Microsoft Word, Excel and PowerPoint
Desirable
- Experience working in Aseptic Preparative Services
- Clinical Trials experience
- Experience with writing SOPs.
- Able to carry out stock management duties.
- Experience delivering presentations.
- Experience training other members of staff.
- Experience contributing to risk assessments and implementing risk management strategies.
- Experience liaising with commercial companies
- Experience working with other departments.
- Experience with temperature monitoring and dealing with temperature excursions.
Knowledge
Essential
- Awareness of GCP
- Awareness of Good Manufacturing Practice (GMP)
- Commitment to own training and prepared to undertake development opportunities and life-long learning.
Desirable
- Trained in Good Clinical Practice (GCP)
- Evidence of CPD
- Pre and in process checking (PIP-C) qualification.
Skills
Essential
- Uses initiative and is aware of own limits, demonstrates common sense.
- Ability to prioritise work load when faced with conflicting duties.
- Able to follow written procedures.
- Able to organise own work.
- Able to manage own time well.
- Able to complete tasks.
- Demonstration of goal focused team working.
- Able to work alone unsupervised and as part of a team.
Desirable
- Able to cover for team leaders, within areas of specialty.
- Able to provide limited cover at short notice for team leaders within the areas of specialism.
Person Specification
Qualifications
Essential
- Registered technician with the General Pharmaceutical Council
Qualifications
Desirable
- Recognised, current Accredited Checking Technician qualification.
Experience
Essential
- Post qualification experience in hospital pharmacy.
- IT literate - use of databases, Microsoft Word, Excel and PowerPoint
Desirable
- Experience working in Aseptic Preparative Services
- Clinical Trials experience
- Experience with writing SOPs.
- Able to carry out stock management duties.
- Experience delivering presentations.
- Experience training other members of staff.
- Experience contributing to risk assessments and implementing risk management strategies.
- Experience liaising with commercial companies
- Experience working with other departments.
- Experience with temperature monitoring and dealing with temperature excursions.
Knowledge
Essential
- Awareness of GCP
- Awareness of Good Manufacturing Practice (GMP)
- Commitment to own training and prepared to undertake development opportunities and life-long learning.
Desirable
- Trained in Good Clinical Practice (GCP)
- Evidence of CPD
- Pre and in process checking (PIP-C) qualification.
Skills
Essential
- Uses initiative and is aware of own limits, demonstrates common sense.
- Ability to prioritise work load when faced with conflicting duties.
- Able to follow written procedures.
- Able to organise own work.
- Able to manage own time well.
- Able to complete tasks.
- Demonstration of goal focused team working.
- Able to work alone unsupervised and as part of a team.
Desirable
- Able to cover for team leaders, within areas of specialty.
- Able to provide limited cover at short notice for team leaders within the areas of specialism.
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.
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.
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).