Job summary
We are looking for an experienced Clinical Pharmacist with a progressive mind-set who will be able to lead and develop our Pharmacy Clinical Trials service here at Portsmouth Hospitals University NHS Trust. We recognise that research and clinical trials are an integral part of the NHS, and by holding this post you will be actively contributing to future healthcare options for patients across the country. The successful candidate will be a hard-working and professional individual who enjoys being a part of the research multidisciplinary team. Ideally, the post holder will have leadership experience to support their management of both internal and external stakeholders, although training and support will be provided to further develop leadership and management skills.
Main duties of the job
The main objectives of this role are to provide leadership for the pharmacy clinical trials department, and to provide effective oversight during the setup, maintenance, and closing-down of all clinical trials involving a medicine at the Trust, from a pharmacy perspective. The post holder will lead their team to build and expand the clinical trials portfolio whilst ensuring compliance with International Conference on Harmonisation of Good Clinical Practice (ICH GCP) and other relevant guidelines and policies.
As the lead for this team you will be expect to liaise closely with research and innovation colleagues, as well as both internal and external stakeholders. Other areas of activity include (but not limited to):
- Ensure new trials involving IMP are assessed for feasibility and to report this back to our Research and Innovation department.
- Monitor and report on the pharmacy resources utilised for clinical trials within the hospital site.
- Maintain good clinical governance of all IMP (and other trials related medicines) stored within the clinical trials pharmacy.
- Be a positive role model for the Trust and the pharmacy and to junior staff.
We are looking for someone who:
- Puts patient care first.
- Will apply good clinical knowledge.
- Has strong team-working and communication skills.
- Has good problem solving and prioritisation skills.
- Has a strong commitment to learning and development of themselves and others.
- Is adaptable and resilient.
About us
The Trust is committed to driving excellence in care for our patients and communities and was rated good by the Care Quality Commission report published 2020 and became a University Hospital. We are ranked as the third in the country for research; embedding education and training across the organisation and we continuously strive to achieve our core values which are at the heart of everything we do. The Trusts main hub is the Queen Alexandra Hospital, starting life as a military hospital over a century ago and now one of the largest hospitals on the south coast and you may have seen us on the TV series Nurses on the Ward. The Trust provides comprehensive secondary care and specialist services to a local population of 675,000 people across South East Hampshire. The Trust employs over 8,000 staff and are #ProudtobePHU; our patients come from all walks of life and so do we. We hire great people from a wide variety of backgrounds, not just because its the right thing to do, but because it makes our hospital stronger. If you share our values and our enthusiasm for providing outstanding care and support for patients, colleagues and our community you will find a home at PHU. In recruiting for our team, we welcome the unique contributions that you can bring in
terms of your education, opinions, culture, ethnicity, race, sex, gender
identity and expression, nation of origin, age, languages spoken, veterans
status, colour, religion, disability, sexual orientation and beliefs.
Job description
Job responsibilities
- To lead on the strategic development of an expert Clinical Trials Pharmacy Service for Portsmouth Hospitals NHS Trust.
- To develop Trust-wide systems to ensure the safe, effective and timely management of Pharmaceutical care for participants in Clinical Trials at Portsmouth Hospitals NHS Trust.
- To develop Trust-wide systems to ensure that Clinical Trials of Medicines meet current UK regulatory requirements and the highest standards of Good Clinical Practice (ICH-GCP).
- To manage an effective team of specialised Pharmacy Clinical Trials Practitioners to deliver a responsive Clinical Trials Service to Researchers, Clinicians, Sponsors, Funders and Research Participants.
- To work with the Principal Pharmacist for Clinical Services, Pharmacy Management Team and the Director of Research to ensure that the Clinical Trials Pharmacy Service is financially sustainable.
- To be responsible for the recovery and management of all research income to Pharmacy Clinical Trials Services.
- To manage a team of Clinical Trials Pharmacists, Technicians and Assistants.
Key Responsibilities:
Clinical Trials Pharmacy Service Development
Working closely with the Trusts Research Department, the Principal Pharmacist for Clinical Services and the Pharmacy Management team this post will lead on:
- Developing a strategic plan for Clinical Trials Pharmacy Services in PHU.
- Ensuring that the Trust is operationally capable of delivering Pharmacy services for both hosted and Trust-sponsored Clinical Trials of Investigational Medicinal Products (CTIMPS).
- Ensuring that the Clinical Trials Pharmacy Service is fully integrated into the Trust.
- Identifying gaps in current service provision and developing Trust-wide systems to ensure the safe, effective and timely management of Pharmaceutical care for participants in Clinical Trials at Portsmouth Hospitals University NHS Trust.
- Identifying gaps in current governance systems and risk of critical findings in Pharmacy from an MHRA inspection.
- Developing and implementing Trust-wide procedures to ensure that Clinical Trials of Medicines meet current UK regulatory requirements and the highest standards of Good Clinical Practice (ICH-GCP).
- Developing a team of specialised Pharmacy Clinical Trials Practitioners to be a responsive Service and expert resource for the following: Research Participants, Researchers, Clinicians, Sponsors, Clinical Research Organisations (CROs), Funding bodies, the Research Department and other Research partners.
- Developing expertise and capacity to ensure that the Service can advise on trial feasibility, trial design, drug supply and procurement, randomisation and blinding procedures, record keeping and medicines management for studies in development or in set-up.
- Ensuring that the Pharmacy Service/Trust is able to support Clinical Trials by assessing any risks and impacts, resource implications, and governance issues associated with the study.
- Ensuring responsibility is taken for IMP accountability at PHU to include good record keeping and reconciliation of IMP at site.
- Developing a Green Light system to confirm Pharmacy readiness to start recruitment. This should take place after R&D approval has been given to confirm that all necessary randomisation, dispensing, accountability, training procedures are in place.
- Delivering training to Trust staff responsible for the management and accountability of medicines in Clinical Trials.
- Ensuring systems are in place for the costing, pricing, recovery and management of income for Pharmacy support to Clinical Trials.
- Ensuring systems are in place to ensure the cost-effective management of clinical trial supplies.
- Developing bids for funding or business cases to increase Service capacity where necessary.
Professional Leadership
- To be directly responsible for the daily management and delivery of effective Clinical Trials Pharmacy Services to the Trust.
- To oversee clinical teams with responsibility for the operational pharmaceutical aspects of Clinical Trials.
- To oversee timely Pharmaceutical Trial Management (set-up, running, closure and archiving) of over 80 CTIMPS. Of these 80 studies approximately 25-30 are expected to begin per annum.
- To manage the competencies of Trust staff responsible for the delivery of effective Clinical Trials Pharmacy Services.
- To deliver training and ensure training is in place for Clinical Trials Pharmacy staff.
- To provide professional expertise and leadership to the Clinical Trials Services team, as well as to research partners such as Sponsoring organisations, funding bodies and clinical researchers.
- To provide advice on all aspects on medicines management in Clinical Trials.
- To represent Pharmacy Clinical Trials Services on Trust committees and working groups, in particular the Research Regulatory Compliance Working Group. This is expected to be monthly.
- To contribute expertise and knowledge to the development and delivery of the Trusts action plan for our regulatory compliance and operational capability to host and sponsor CTIMPS.
- To be a primary point of contact for the Research Director/Department and in the event of an MHRA inspection.
- To work and support Sponsors/ study monitors to ensure good research pharmacy practice.
- To ensure that any complaints or Clinical Incidents regarding the Pharmacy Clinical Trials Service are dealt with efficiently and in accordance with Trust policies.
- To manage the income and expenditure for Pharmacy involvement in Clinical Trials.
- To manage the Clinical Trial supplies to ensure that stock is sufficient to cover the requirements of the trial patients, to ensure that supplies are purchased in a cost-effective and timely manner, and that appropriate storage conditions are maintained and auditable.
- To advise researchers/the research department with regards to which medicines are on the Trusts formulary and to provide costings/prices upon request.
- To be the professional link between Research/Clinical Trials Services and Clinical Pharmacy Services.
- To develop and maintain excellent relationships with users of the Pharmacy Clinical Trials Services.
- To maintain clinical pharmacy skills, knowledge and experience in order to be able to perform in a safe and effective manner.
- To act as a practitioner in a mutually agreed clinical specialty.
Other
- To assist in selection and recruitment of staff as required.
- To undertake regular one to ones and appraisals for managed staff, including setting of their personal development plan and agreed objectives and review as appropriate.
- To effectively manage performance related issues.
- To act as a tutor and mentor for students enrolled onto various post-graduate diploma programs.
- To act as a pre-registration pharmacist tutor if required.
- To assist in the training of all grades of pharmacy staff and other professions within the MDT to nurture both clinical and practical knowledge and expertise within the Trust.
Professional Input to Dispensary
- To carry out pharmaceutical duties associated with the dispensing of inpatient, discharge and outpatient prescriptions.
- Analyse complex prescriptions from all specialities and advise medical staff if errors are identified or improvements/optimisation in therapy can be made.
- To supervise supporting staff including pharmacy technicians and assistants under the direction of a senior pharmacist.
- To participate in the departmental weekend, late night and Bank Holiday services rotas.
- To maintain security of medication at all times in line with departmental and Trust policy including non-disclosure of appropriate pharmacy security codes and advising on the safe and secure storage of medicines within clinical areas.
- To undertake other reasonable duties, within the framework of the post, as directed by the Pharmacy Senior Management team.
- Carry out professional duties in accordance with GPhC standards for practice, including the requirement to undertake continuing professional development (CPD) in line with statutory requirements.
Job description
Job responsibilities
- To lead on the strategic development of an expert Clinical Trials Pharmacy Service for Portsmouth Hospitals NHS Trust.
- To develop Trust-wide systems to ensure the safe, effective and timely management of Pharmaceutical care for participants in Clinical Trials at Portsmouth Hospitals NHS Trust.
- To develop Trust-wide systems to ensure that Clinical Trials of Medicines meet current UK regulatory requirements and the highest standards of Good Clinical Practice (ICH-GCP).
- To manage an effective team of specialised Pharmacy Clinical Trials Practitioners to deliver a responsive Clinical Trials Service to Researchers, Clinicians, Sponsors, Funders and Research Participants.
- To work with the Principal Pharmacist for Clinical Services, Pharmacy Management Team and the Director of Research to ensure that the Clinical Trials Pharmacy Service is financially sustainable.
- To be responsible for the recovery and management of all research income to Pharmacy Clinical Trials Services.
- To manage a team of Clinical Trials Pharmacists, Technicians and Assistants.
Key Responsibilities:
Clinical Trials Pharmacy Service Development
Working closely with the Trusts Research Department, the Principal Pharmacist for Clinical Services and the Pharmacy Management team this post will lead on:
- Developing a strategic plan for Clinical Trials Pharmacy Services in PHU.
- Ensuring that the Trust is operationally capable of delivering Pharmacy services for both hosted and Trust-sponsored Clinical Trials of Investigational Medicinal Products (CTIMPS).
- Ensuring that the Clinical Trials Pharmacy Service is fully integrated into the Trust.
- Identifying gaps in current service provision and developing Trust-wide systems to ensure the safe, effective and timely management of Pharmaceutical care for participants in Clinical Trials at Portsmouth Hospitals University NHS Trust.
- Identifying gaps in current governance systems and risk of critical findings in Pharmacy from an MHRA inspection.
- Developing and implementing Trust-wide procedures to ensure that Clinical Trials of Medicines meet current UK regulatory requirements and the highest standards of Good Clinical Practice (ICH-GCP).
- Developing a team of specialised Pharmacy Clinical Trials Practitioners to be a responsive Service and expert resource for the following: Research Participants, Researchers, Clinicians, Sponsors, Clinical Research Organisations (CROs), Funding bodies, the Research Department and other Research partners.
- Developing expertise and capacity to ensure that the Service can advise on trial feasibility, trial design, drug supply and procurement, randomisation and blinding procedures, record keeping and medicines management for studies in development or in set-up.
- Ensuring that the Pharmacy Service/Trust is able to support Clinical Trials by assessing any risks and impacts, resource implications, and governance issues associated with the study.
- Ensuring responsibility is taken for IMP accountability at PHU to include good record keeping and reconciliation of IMP at site.
- Developing a Green Light system to confirm Pharmacy readiness to start recruitment. This should take place after R&D approval has been given to confirm that all necessary randomisation, dispensing, accountability, training procedures are in place.
- Delivering training to Trust staff responsible for the management and accountability of medicines in Clinical Trials.
- Ensuring systems are in place for the costing, pricing, recovery and management of income for Pharmacy support to Clinical Trials.
- Ensuring systems are in place to ensure the cost-effective management of clinical trial supplies.
- Developing bids for funding or business cases to increase Service capacity where necessary.
Professional Leadership
- To be directly responsible for the daily management and delivery of effective Clinical Trials Pharmacy Services to the Trust.
- To oversee clinical teams with responsibility for the operational pharmaceutical aspects of Clinical Trials.
- To oversee timely Pharmaceutical Trial Management (set-up, running, closure and archiving) of over 80 CTIMPS. Of these 80 studies approximately 25-30 are expected to begin per annum.
- To manage the competencies of Trust staff responsible for the delivery of effective Clinical Trials Pharmacy Services.
- To deliver training and ensure training is in place for Clinical Trials Pharmacy staff.
- To provide professional expertise and leadership to the Clinical Trials Services team, as well as to research partners such as Sponsoring organisations, funding bodies and clinical researchers.
- To provide advice on all aspects on medicines management in Clinical Trials.
- To represent Pharmacy Clinical Trials Services on Trust committees and working groups, in particular the Research Regulatory Compliance Working Group. This is expected to be monthly.
- To contribute expertise and knowledge to the development and delivery of the Trusts action plan for our regulatory compliance and operational capability to host and sponsor CTIMPS.
- To be a primary point of contact for the Research Director/Department and in the event of an MHRA inspection.
- To work and support Sponsors/ study monitors to ensure good research pharmacy practice.
- To ensure that any complaints or Clinical Incidents regarding the Pharmacy Clinical Trials Service are dealt with efficiently and in accordance with Trust policies.
- To manage the income and expenditure for Pharmacy involvement in Clinical Trials.
- To manage the Clinical Trial supplies to ensure that stock is sufficient to cover the requirements of the trial patients, to ensure that supplies are purchased in a cost-effective and timely manner, and that appropriate storage conditions are maintained and auditable.
- To advise researchers/the research department with regards to which medicines are on the Trusts formulary and to provide costings/prices upon request.
- To be the professional link between Research/Clinical Trials Services and Clinical Pharmacy Services.
- To develop and maintain excellent relationships with users of the Pharmacy Clinical Trials Services.
- To maintain clinical pharmacy skills, knowledge and experience in order to be able to perform in a safe and effective manner.
- To act as a practitioner in a mutually agreed clinical specialty.
Other
- To assist in selection and recruitment of staff as required.
- To undertake regular one to ones and appraisals for managed staff, including setting of their personal development plan and agreed objectives and review as appropriate.
- To effectively manage performance related issues.
- To act as a tutor and mentor for students enrolled onto various post-graduate diploma programs.
- To act as a pre-registration pharmacist tutor if required.
- To assist in the training of all grades of pharmacy staff and other professions within the MDT to nurture both clinical and practical knowledge and expertise within the Trust.
Professional Input to Dispensary
- To carry out pharmaceutical duties associated with the dispensing of inpatient, discharge and outpatient prescriptions.
- Analyse complex prescriptions from all specialities and advise medical staff if errors are identified or improvements/optimisation in therapy can be made.
- To supervise supporting staff including pharmacy technicians and assistants under the direction of a senior pharmacist.
- To participate in the departmental weekend, late night and Bank Holiday services rotas.
- To maintain security of medication at all times in line with departmental and Trust policy including non-disclosure of appropriate pharmacy security codes and advising on the safe and secure storage of medicines within clinical areas.
- To undertake other reasonable duties, within the framework of the post, as directed by the Pharmacy Senior Management team.
- Carry out professional duties in accordance with GPhC standards for practice, including the requirement to undertake continuing professional development (CPD) in line with statutory requirements.
Person Specification
Experience
Essential
- Significant hospital pharmacy experience involving clinical pharmacy services.
- Experience of Clinical Trials of Investigational Medicinal Products.
- Experience of working in a multidisciplinary team.
Desirable
- Extensive pharmacy experience in a clinical role.
- Previous experience or involvement in managing/developing services.
- Experience or involvement in designing clinical trials of medicines.
- Experience of an MHRA inspection or developing systems to ensure compliance with current UK regulations for clinical trials of medicines.
- Experience of preparing/managing budgets.
- Experience of developing drug protocols and contributing to formulary development.
Skills and Knowledge
Essential
- Good interpersonal skills.
- Good leadership skills.
- Good managerial skills.
- Excellent communication skills.
- Good, demonstrable knowledge of UK Regulations for Clinical Trials of Medicines and standards of Good Clinical Practice (ICH-GCP).
- Demonstrable ability to organise and manage a complex workload and work accurately under pressure.
- Demonstrable ability to motivate self and others.
- Demonstrable ability to negotiate a positive outcome influencing skills.
- Demonstrable ability to work in a team.
- Demonstrable ability to manage a team.
- Demonstrable confidence as a clinical practitioner.
- Demonstrable ability to use initiative.
- Demonstrable ability to maintain quality standards.
- Evidence of successful relationships with others.
Desirable
- Sound knowledge of clinical trials and relevant regulations.
- Clinical appraisal skills.
- Good knowledge of Clinical Trials Design.
Qualifications
Essential
- Masters or bachelors degree in pharmacy.
- Registered with the General Pharmaceutical Council.
- Certificate in Clinical Pharmacy.
- Completed or studying for Diploma in Clinical Pharmacy.
- Formal Clinical Trials Training i.e., ICH-GCP Training.
Desirable
- Member of Royal Pharmaceutical Society.
- NMP qualification or working towards and eligible for training.
- Member of specialist pharmacist practice group e.g., UKCPA.
Person Specification
Experience
Essential
- Significant hospital pharmacy experience involving clinical pharmacy services.
- Experience of Clinical Trials of Investigational Medicinal Products.
- Experience of working in a multidisciplinary team.
Desirable
- Extensive pharmacy experience in a clinical role.
- Previous experience or involvement in managing/developing services.
- Experience or involvement in designing clinical trials of medicines.
- Experience of an MHRA inspection or developing systems to ensure compliance with current UK regulations for clinical trials of medicines.
- Experience of preparing/managing budgets.
- Experience of developing drug protocols and contributing to formulary development.
Skills and Knowledge
Essential
- Good interpersonal skills.
- Good leadership skills.
- Good managerial skills.
- Excellent communication skills.
- Good, demonstrable knowledge of UK Regulations for Clinical Trials of Medicines and standards of Good Clinical Practice (ICH-GCP).
- Demonstrable ability to organise and manage a complex workload and work accurately under pressure.
- Demonstrable ability to motivate self and others.
- Demonstrable ability to negotiate a positive outcome influencing skills.
- Demonstrable ability to work in a team.
- Demonstrable ability to manage a team.
- Demonstrable confidence as a clinical practitioner.
- Demonstrable ability to use initiative.
- Demonstrable ability to maintain quality standards.
- Evidence of successful relationships with others.
Desirable
- Sound knowledge of clinical trials and relevant regulations.
- Clinical appraisal skills.
- Good knowledge of Clinical Trials Design.
Qualifications
Essential
- Masters or bachelors degree in pharmacy.
- Registered with the General Pharmaceutical Council.
- Certificate in Clinical Pharmacy.
- Completed or studying for Diploma in Clinical Pharmacy.
- Formal Clinical Trials Training i.e., ICH-GCP Training.
Desirable
- Member of Royal Pharmaceutical Society.
- NMP qualification or working towards and eligible for training.
- Member of specialist pharmacist practice group e.g., UKCPA.
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).
