Job summary
The post-holder is responsible to assist with planning, delivering and evaluating high standards of the technical pharmacy clinical trials service.
They will provide advice to the Clinical Trials Pharmacist on matters relating to research activities (Clinical Trials) in the dispensaries specifically on risk assessment and impact of the research on the dispensary.
They will be responsible for the set-up and supervising the running of the Clinical Trials within the dispensary, monitoring quality and effectiveness.
Main duties of the job
- Obtain Good Clinical Practice (GCP) Training.
- Work within the Medicines for Human Use (Clinical Trial) Regulations 2004 and the EU Directives relating to Clinical Trials and the Research Governance Framework.
- Review all Clinical Trial protocols which will involve the dispensary prior to Trust Research & Innovation(R&I) Approval.
- Participate in confidential communication with the Clinical Trials Pharmacist, Investigators, Research Nurses, Trust R&I, Sponsors, Pharmaceutical Company Clinical Research Associates, Pharmacy Aseptic Services Unit (PASU), dispensary staff and the Clinical Trials PASU Technician during the Pharmacy Approval process, the setting up of new studies and during the running of the study.
Develop, implement and maintain clear and accurate written SOPs for dispensing for each clinical trial in the dispensaries in accordance with Good Clinical Practice (GCP) and each study's protocol.
- Ensure Clinical Trial protocols are followed during dispensing of Clinical Trial Investigational Medical Products and other drugs included in the protocol.
- Maintain and setup systems to reclaim any reimbursement of free or discounted stock of Investigational Medical Product used in Clinical Trials within the dispensaries.
- Maintain Clinical Trial filing systems.
- Design drug accountability documentation and prescriptions for Clinical Trials, if required.
- Work in line with R&I objectives/strategy
About us
The Royal Berkshire NHS Foundation Trust is the main provider of hospital services for the population of Reading, Newbury, Wokingham and the towns and villages of west Berkshire.At our heart we are a local hospital that works with NHS and social care partners to provide excellent healthcare services for over 500,000 people who currently live in our catchment area. We also provide specialist hospital services beyond the county's borders.We employ more than 5,500 staff from 39 different nationalities and deliver care from a network of facilities across sites in Bracknell, Henley-on-Thames, Reading, Thatcham and Windsor, offering services such as:Acute medical services at RBH in ReadingOphthalmology services at Prince Charles Eye Unit, WindsorDialysis services in WindsorDay surgery and acute outpatient services at West Berkshire Community HospitalCancer, renal and outpatient services in BracknellOutpatient services at Townlands Hospital, Henley.
We are actively involved in research and development which supports our high -quality work andbenefits both patients and staff. We offer great careers for doctors, nurses, midwives and otherprofessions.
www.royalberkshire.nhs.uk
Job description
Job responsibilities
Develop, organise and maintain the Pharmacy Clinical Trials Services in the dispensaries, in conjunction with the Clinical Trials Pharmacist, ensuring compliance with Good Clinical Practice (GCP) guidelines, the Research Governance Framework, the E.U Clinical Trials Directive, the Medicines for Human Use (Clinical Trial) Regulations 2004 and other relevant guidelines, regulations and policies.
- Manage the process of purchasing, ordering, receipt, storage, dispensing, return and disposal of Clinical Trial drugs within the dispensaries and maintain stock levels.
- Manage and maintain the database to monitor patients activity in non-commercially Sponsored Clinical Trials within the dispensaries.
Manage and maintain the database of the training of the dispensary staff undertaking Clinical trial work.
- Obtain Good Clinical Practice (GCP) Training.
- Work within the Medicines for Human Use (Clinical Trial) Regulations 2004 and the EU Directives relating to Clinical Trials and the Research Governance Framework.
- Review all Clinical Trial protocols which will involve the dispensary prior to Trust Research & Innovation(R&I) Approval.
- Participate in confidential communication with the Clinical Trials Pharmacist, Investigators, Research Nurses, Trust R&I, Sponsors, Pharmaceutical Company Clinical Research Associates, Pharmacy Aseptic Services Unit (PASU), dispensary staff and the Clinical Trials PASU Technician during the Pharmacy Approval process, the setting up of new studies and during the running of the study.
Develop, implement and maintain clear and accurate written SOPs for dispensing for each clinical trial in the dispensaries in accordance with Good Clinical Practice (GCP) and each studys protocol.
- Ensure Clinical Trial protocols are followed during dispensing of Clinical Trial Investigational Medical Products and other drugs included in the protocol.
- Maintain and setup systems to reclaim any reimbursement of free or discounted stock of Investigational Medical Product used in Clinical Trials within the dispensaries.
- Maintain Clinical Trial filing systems.
- Design drug accountability documentation and prescriptions for Clinical Trials, if required.
- Work in line with R&I objectives/strategy
Job description
Job responsibilities
Develop, organise and maintain the Pharmacy Clinical Trials Services in the dispensaries, in conjunction with the Clinical Trials Pharmacist, ensuring compliance with Good Clinical Practice (GCP) guidelines, the Research Governance Framework, the E.U Clinical Trials Directive, the Medicines for Human Use (Clinical Trial) Regulations 2004 and other relevant guidelines, regulations and policies.
- Manage the process of purchasing, ordering, receipt, storage, dispensing, return and disposal of Clinical Trial drugs within the dispensaries and maintain stock levels.
- Manage and maintain the database to monitor patients activity in non-commercially Sponsored Clinical Trials within the dispensaries.
Manage and maintain the database of the training of the dispensary staff undertaking Clinical trial work.
- Obtain Good Clinical Practice (GCP) Training.
- Work within the Medicines for Human Use (Clinical Trial) Regulations 2004 and the EU Directives relating to Clinical Trials and the Research Governance Framework.
- Review all Clinical Trial protocols which will involve the dispensary prior to Trust Research & Innovation(R&I) Approval.
- Participate in confidential communication with the Clinical Trials Pharmacist, Investigators, Research Nurses, Trust R&I, Sponsors, Pharmaceutical Company Clinical Research Associates, Pharmacy Aseptic Services Unit (PASU), dispensary staff and the Clinical Trials PASU Technician during the Pharmacy Approval process, the setting up of new studies and during the running of the study.
Develop, implement and maintain clear and accurate written SOPs for dispensing for each clinical trial in the dispensaries in accordance with Good Clinical Practice (GCP) and each studys protocol.
- Ensure Clinical Trial protocols are followed during dispensing of Clinical Trial Investigational Medical Products and other drugs included in the protocol.
- Maintain and setup systems to reclaim any reimbursement of free or discounted stock of Investigational Medical Product used in Clinical Trials within the dispensaries.
- Maintain Clinical Trial filing systems.
- Design drug accountability documentation and prescriptions for Clinical Trials, if required.
- Work in line with R&I objectives/strategy
Person Specification
Education/ Qualifications/ Training:
Essential
- NVQ level 3 Pharmacy services or BTEC in Pharmaceutical Sciences or SCOTVEC equivalent.
- Professional registration as a Pharmacy Technician through Technician membership of the United Kingdom General Pharmaceutical Council
- Trained in a recognised hospital or retail establishment.
- Good written and spoken English
- Accurate worker. Good attention to detail.
Desirable
- Accredited Checking Technician qualification
- Awareness of legislation relating to Good Clinical Practice
- Computer Literacy
- Experience of risk assessment
- Experience of working to Clinical Trial protocols
Experience:
Essential
- Recent extensive experience as a qualified pharmacy technician in a UK hospital including experience of Dispensary services and extended roles of technicians.
- Experience in mentoring / facilitation / teaching / assessing / coaching
- Procedure/Policy writing.
- Good attention to detail.
- Ability to intervene professionally when necessary
- Demonstrates excellent team working
Desirable
- Experience of working to Clinical Trial protocols
- Experience of 'ARIA', EPMA and 'JAC' computer system.
- Excellent interpersonal skills with particular ability to liaise effectively with multidisciplinary team members
Person Specification
Education/ Qualifications/ Training:
Essential
- NVQ level 3 Pharmacy services or BTEC in Pharmaceutical Sciences or SCOTVEC equivalent.
- Professional registration as a Pharmacy Technician through Technician membership of the United Kingdom General Pharmaceutical Council
- Trained in a recognised hospital or retail establishment.
- Good written and spoken English
- Accurate worker. Good attention to detail.
Desirable
- Accredited Checking Technician qualification
- Awareness of legislation relating to Good Clinical Practice
- Computer Literacy
- Experience of risk assessment
- Experience of working to Clinical Trial protocols
Experience:
Essential
- Recent extensive experience as a qualified pharmacy technician in a UK hospital including experience of Dispensary services and extended roles of technicians.
- Experience in mentoring / facilitation / teaching / assessing / coaching
- Procedure/Policy writing.
- Good attention to detail.
- Ability to intervene professionally when necessary
- Demonstrates excellent team working
Desirable
- Experience of working to Clinical Trial protocols
- Experience of 'ARIA', EPMA and 'JAC' computer system.
- Excellent interpersonal skills with particular ability to liaise effectively with multidisciplinary team members
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).
