Job summary
The post holder will work closely with the Lead Pharmacist for Cancer Services, and Lead Research Nurse to ensure the smooth running of clinical trials at The Princess Alexandra Hospital NHS Trust. Key responsibilities include the following:
To maintain and support the Pharmacy Clinical Trials service in accordance with current UK Clinical Trials Regulations and all updates, Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) guidelines and departmental procedures, ensuring provision of a high-quality service to non-commercial and commercial sponsors, contract research organisations (CROs), staff and patients at The Princess Alexandra Hospital NHS Trust
Leading on specialist capacity and capability review, pharmacy approval and setup of clinical trials
Checking the pharmacy set-up of clinical trials
Reviewing and processing amendments and checking amended paperwork
Assisting with the operational delivery of clinical trials
Developing close working relationships with R&D, Principal Investigators, research delivery teams and pharmacy including clinical services, technical services, QC, and procurement teams
Provide pharmacy input at Trials Feasibility and site selection meetings
Representing the clinical trials pharmacy team at other internal and external meetings as required.
Provide line management responsibility for the Clinical Trials Pharmacy Technician.
Main duties of the job
The post holder will be responsible for leading on the capacity and capability review and set-up of a portfolio of clinical trials across a variety of clinical specialities including cancer, respiratory, rheumatology, Gastroenterology and others. Lead on the day-to-day operational delivery of clinical trials.
The postholder will:
- Ensure clinical trials are reviewed, set-up, delivered and closed-out in compliance with all relevant legislation, guidelines and local policies and procedures
- Be a primary point of contact for research delivery teams and provide specialist advice and input on all aspects of clinical trials to R&D, Investigators, and research teams
- Be a primary point of contact for sponsors (commercial and non-commercial) and contract research organisations (CROs) from pre-site selection to close-out.
- Provide support and be a point of escalation for pharmacy clinical trial technician and practitioner staff
- Review, interpret and critique clinical trial protocols, investigator brochures, pharmacy manuals and other associated documentation incorporating further comment from appropriate specialist clinical and technical colleagues with respect to the capacity and capability assessment of the safe and effective running of clinical trials. Feedback any points of concern identified during trial review to Principal Investigators and delivery teams as appropriate, and work to identify and deliver solutions to ensure safe and effective clinical trial delivery.
About us
The Princess Alexandra Hospital NHS Trust (PAHT) provides a full range of general acute, outpatient and diagnostic services at The Princess Alexandra Hospital in Harlow, the Herts and Essex Hospital in Bishop’s Stortford, and St Margaret’s Hospital in Epping.
We employ 3,500 staff and serve a local population of around 350,000 people living in west Essex and east Hertfordshire, centred on the M11 corridor and the towns of Harlow, Bishop’s Stortford and Epping. Our extended catchment area incorporates a population of up to 500,000 and includes the areas of Hoddesdon, Cheshunt and Broxbourne in Hertfordshire.
Our Values
The Princess Alexandra Promise to our patients as identified by our 3 values which will contribute to improving our patient experiences:
Patient at heart – Always holding the patient and their wellbeing at the centre of our thoughts and efforts
Everyday excellence – Sharing and celebrating our successes, being honest when we get it wrong, giving us the ability to learn from both
Creative collaboration – Knowing strength comes from diversity, we combine our experiences, skills and talents, working together to find new and better ways to care
The Trust believes in investing in all our staff and rewarding high standards of care whilst building for excellence and in return we expect our staff to uphold the Trust values to the highest level.
Job description
Job responsibilities
- Provide clinical trials pharmacy input for Trials Feasibility and become a core member of the RD&I Group.
- Undertake set-up of approved clinical trials including preparing all trial specific procedures, preparing and overseeing the build of all trial specific prescriptions which may include building protocols on electronic prescribing systems (Chemocare for cancer trials), sourcing any required medications and consumables, and liaising with the pharmacy clinical trial technician on the creation of dose preparation worksheets for aseptic studies, attending site initiation visits and undertaking any required training to enable trial delivery.
- Check the pharmacy set-up pharmacy-trial specific procedures, prescriptions, and other associated documents, across all specialities
- Review, process and check amendments to clinical trials across all specialities
- Assist the Clinical Trials Pharmacy Technician, in the operational delivery of clinical trials on a day-to-day basis
- Assist the Clinical Trials Team in the preparation for GCP audit and regulatory inspection including being interviewed by inspectors / auditors where required
- Attend internal and external meetings on behalf of the clinical trials pharmacy where representation is require
Job description
Job responsibilities
- Provide clinical trials pharmacy input for Trials Feasibility and become a core member of the RD&I Group.
- Undertake set-up of approved clinical trials including preparing all trial specific procedures, preparing and overseeing the build of all trial specific prescriptions which may include building protocols on electronic prescribing systems (Chemocare for cancer trials), sourcing any required medications and consumables, and liaising with the pharmacy clinical trial technician on the creation of dose preparation worksheets for aseptic studies, attending site initiation visits and undertaking any required training to enable trial delivery.
- Check the pharmacy set-up pharmacy-trial specific procedures, prescriptions, and other associated documents, across all specialities
- Review, process and check amendments to clinical trials across all specialities
- Assist the Clinical Trials Pharmacy Technician, in the operational delivery of clinical trials on a day-to-day basis
- Assist the Clinical Trials Team in the preparation for GCP audit and regulatory inspection including being interviewed by inspectors / auditors where required
- Attend internal and external meetings on behalf of the clinical trials pharmacy where representation is require
Person Specification
Education & Qualifications
Essential
- Masters of Pharmacy (MPharm) or equivalent
- Post Graduate Clinical Qualification/ Diploma in Pharmacy Practice or equivalent
- Registration with GPhC
Desirable
- Qualification in Clinical Research – GCP
Exoerience
Essential
- Extensive Pharmacy experience in hospital (minimum 3 years)
- Computer Literate
Desirable
- Experience in clinical trials procedures, commercial & non-commercial
- Experience of managing a staff group
- Experience of budget management
Skills & Knowledge
Essential
- Understanding of hospital pharmacy systems
- Excellent interpersonal skills
- Effective oral and written communication
Desirable
- Knowledge of all aspects of clinical trials
- Knowledge of medicines legislation associated with clinical trials
- Knowledge of quality assurance and systems for error reduction
Person Specification
Education & Qualifications
Essential
- Masters of Pharmacy (MPharm) or equivalent
- Post Graduate Clinical Qualification/ Diploma in Pharmacy Practice or equivalent
- Registration with GPhC
Desirable
- Qualification in Clinical Research – GCP
Exoerience
Essential
- Extensive Pharmacy experience in hospital (minimum 3 years)
- Computer Literate
Desirable
- Experience in clinical trials procedures, commercial & non-commercial
- Experience of managing a staff group
- Experience of budget management
Skills & Knowledge
Essential
- Understanding of hospital pharmacy systems
- Excellent interpersonal skills
- Effective oral and written communication
Desirable
- Knowledge of all aspects of clinical trials
- Knowledge of medicines legislation associated with clinical trials
- Knowledge of quality assurance and systems for error reduction
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
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).
