Job summary
My name is Alfonso, I am privileged to lead our clinical and technical team of Pharmacists, Technicians, Assistants and Apprentices as we provide support services to our clinical trial research teams on all of our trust sites throughout Oxfordshire. We are looking for an experienced Pharmacist to cover the role of Lead Pharmacist for Clinical Trials.
As the Lead Pharmacist for Clinical Trials you will need to provide an efficient service for all aspects of pharmacy based clinical trials. You will need to work with the Clinical Trials team to strategically plan and manage the workload for clinical trials and provide specialised advice to Researchers related to Investigational Medicinal Products (IMPs). You will need to ensure the safe and effective management and use of Investigational Medicinal Products (IMPs) on all sites within the Trust. The role will focus on the clinical side of the service the team provides.
If you are interested in an informal discussion about the role I would be very pleased to chat with you about this. Looking forward to hearing from you.
Main duties of the job
1. To provide support to the Head of Clinical Trials Pharmacy in order to provide an efficient service for all aspects of pharmacy based clinical trials
2. To work with the Clinical Trials team to strategically plan and manage the workload for the clinical trials that are aseptically prepared by the Partnership Organisation.
3. To work with the Clinical Trials and Quality Assurance Pharmacy Team Manager to strategically plan and manage the workload for all clinical trials based across all four sites.
4. To provide specialised advice to Researchers related to Investigational Medicinal Products (IMPs) and associated products during development of clinical trial protocols and advice and information regarding Clinical Trial Authorisation (CTA) applications.
5. To deputise for the Clinical Trials and Quality Assurance Pharmacy Team Manager as appropriate.
6. To provide a clinical pharmacy service to a clinical area (as clinical trial workload and priorities allow).
7. To ensure the safe and effective management and use of Investigational Medicinal Products (IMPs) on all sites within the Trust and it's research partners in accordance with relevant regulations
8. To be an active member of the pharmacy department and in the specialist area/Directorate team, and ensure continuous two-way exchange of information to maintain high standards of medicines use within the Trust.
About us
Oxford University Hospitals NHS Foundation Trust is one of the largest NHS teaching trusts in the country. It provides a wide range of general and specialist clinical services and is a base for medical education, training and research. Find out more here www.ouh.nhs.uk
The Trust comprises four hospitals - the John Radcliffe Hospital, Churchill Hospital and Nuffield Orthopaedic Centre in Headington and the Horton General Hospital in Banbury.
Our values, standards and behaviours define the quality of clinical care we offer and the professional relationships we make with our patients, colleagues and the wider community. We call thisDelivering Compassionate Excellenceand its focus is on our values of compassion, respect, learning, delivery, improvement and excellence. These values put patients at the heart of what we do and underpin the quality healthcare we would like for ourselves or a member of our family. Watch how we set out to deliver compassionate excellence via theOUH YouTube channel.
Job description
Job responsibilities
Standards in Clinical Research:
- To support the Clinical Trials and Quality Assurance Pharmacy Team Manager to develop, implement and maintain the strategy for pharmacy support to clinical trials and those aseptically prepared by the Partnership Organisation in association with key researchers, the OUH R&D department and the Biomedical Research Centre.
- To ensure compliance with relevant standards for the operation and management of clinical trials.
- To advise and support researchers in complexities and feasibility of trial design and REC applications, particularly in relation to obtaining a CTA, if requested.
- To train medical and nursing staff in aspects of handling drugs in clinical trials.
- To liaise with other centres for clinical research to ensure common standards of practice.
- To develop and maintain expertise and knowledge in all aspects of the use of medicines in research.
- To assist in the development of Pharmacy policies and procedures to support the delivery of clinical trials involving medication and related substances.
- To co-ordinate purchase of bulk product if required and to supervise packing down activities in accordance with GMP, and with previously approved batch record documentation and labels (primary and secondary).
Support to Individual Clinical Trials
- To support the clinical trials technicians and junior pharmacists as required in multidisciplinary team meetings with Investigators to initiate, manage and close down trials hence ensuring pharmacy participation.
- To assist the Clinical Trials and Quality Assurance Pharmacy Team Manager in the coordination of clinical trial set ups and to actively set up, review and sign off clinical trials.
- To audit documentation and processes for individual clinical trials.
- To ensure the appropriate disposal of unwanted trial materials.
- To support the development of a scheduling system for clinical trials.
- To liaise with the Specialist Clinical Pharmacists when approving or initiating new projects.
- To act as a source of Research expertise to advice on complex issues such as trial design, procurement, randomisation, blinding, documentation for in-house clinical trials and to defend / justify the opinions or decisions if the advice is challenged.
- To provide support and guidance on, and to participate in the costing and invoicing of clinical trials and ensure appropriate systems are in place.
Clinical Practice Role - (as clinical trial workload and priorities allow)
- To maintain clinical expertise and develop particular areas of interest as appropriate and in accordance with the Trust and Pharmacy strategy.
- To provide a ward-based clinical pharmacy service according to Trust agreed standards including:
- Individual prescription review to optimise therapy
- Confirmation of the patients medication history
- Advice on dosage, side-effects, cautions and monitoring required
- Advise on administration of medicines
- Appropriate and clear endorsing of prescriptions to ensure safe practice
- Monitor the effect and appropriateness of medication
- Education of patients on their medication
- Involvement in discharge planning and provision of discharge medication
- Use non-medical prescribing skills and qualifications, if applicable
3. To provide clinical pharmacy cover to other ward areas within the team on a reciprocal basis.
4. To ensure medicines are used appropriately, safely and cost-effectively in accordance with Trust policy, standard operating procedures and medicines legislation.
5. To monitor medicines use within the ward area. This includes recording of significant clinical interventions and risk management including:
- Participation in investigating clinical incidents
- Recording significant clinical incidents/near misses
- Ensuring compliance with medicines legislation and local policies
6. To use available information to influence prescribers and ensure the most cost-effective choice of therapy.
7. If already accredited, to be involved in a pharmacist led outpatient clinic as a non-medical prescriber if required by the clinical area and agreed by your line manager.
8. To contribute to the monitoring of safe, effective and economic use of medicines in the directorate in accordance with national and local guidelines, working with the Pharmacist Team Manager and Medicines Effectiveness Pharmacist.
9. To develop good working relationships and communication with clinical and managerial staff within area of specialist practice and provide a link regarding all aspects of the Pharmacy Service and Medicines Management.
10. To support the appropriate management of clinical trials and unlicensed medicines.
11. To support the implementation of medicines related policies such as reuse of patients own medicines, green bags etc across the Directorate.
12. To be aware of developments within own area of practice, the Directorate and Pharmacy/Medicines Management in general to develop own area of specialist practice, to share good practice and act as a resource.
13. To act as a role model and mentor for clinical pharmacy.
14. To be aware of Medicines Management/Medicines Safety issues for clinical area/directorate and where appropriate pharmacy, to ensure incident forms are completed, risk assessments are undertake and any learning is implemented and shared.
15. To develop personal practice research in accordance with the Trust and pharmacy strategy.
16. To contribute to local, national and international specialist interest groups and conferences/meetings as required.
17. To provide teaching for the pharmacy and directorate teams as required.
18. To act as knowledge base/resource for the specialist area and to keep up to date with current trends and research in the specialist area.
19. With the rest of the members of the clinical pharmacy team to support the strategic developments of the service e.g. electronic prescribing, improved discharge processes, accredited technician checking etc.
20. Actively contribute to the planning and efficient co-ordination of clinical pharmacy initiatives including discharge planning, prescribing protocols, pharmacists on consultant ward rounds etc.
21. To contribute to and implement the clinical governance plans of the clinical area and the pharmacy clinical governance plans.
Lead Pharmacist, Clinical Trials Role
- To manage the Clinical Trials Pharmacy Team in the absence of the Clinical Trials and Quality Assurance Pharmacy Team Manager.
- To deputise for the Clinical Trials and Quality Assurance Pharmacy Team Manager at e.g. Pharmacy or Directorate Meetings in the absence of or at the request of the Clinical Trials and Quality Assurance Pharmacy Team Manager or Pharmacy Clinical Services Manager or Chief pharmacist.
- To manage a group of staff within the team.
Professional Role:
- To ensure confidentiality is maintained at all times
- To be professionally accountable for actions and advice
- To use experience and clinical judgment to assist in problem-solving and trouble-shooting within the Pharmacy department.
- To give professional support to the site operational managers.
- To be aware of training and competency assessment of pre-registration pharmacist trainees, diploma pharmacists and student pharmacy technicians and participate in their training and competency assessment as required.
- To support the dispensaries by screening, dispensing and checking clinical trial prescriptions as needed.
- To support the Clinical Trials Aseptic Unit in the releasing of aseptically prepared doses and other activities required by the Unit as needed and to maintain competency.
- To participate in weekend and bank holiday working according to rota.
- Any other reasonable duties as requested by the Chief Pharmacist
Job description
Job responsibilities
Standards in Clinical Research:
- To support the Clinical Trials and Quality Assurance Pharmacy Team Manager to develop, implement and maintain the strategy for pharmacy support to clinical trials and those aseptically prepared by the Partnership Organisation in association with key researchers, the OUH R&D department and the Biomedical Research Centre.
- To ensure compliance with relevant standards for the operation and management of clinical trials.
- To advise and support researchers in complexities and feasibility of trial design and REC applications, particularly in relation to obtaining a CTA, if requested.
- To train medical and nursing staff in aspects of handling drugs in clinical trials.
- To liaise with other centres for clinical research to ensure common standards of practice.
- To develop and maintain expertise and knowledge in all aspects of the use of medicines in research.
- To assist in the development of Pharmacy policies and procedures to support the delivery of clinical trials involving medication and related substances.
- To co-ordinate purchase of bulk product if required and to supervise packing down activities in accordance with GMP, and with previously approved batch record documentation and labels (primary and secondary).
Support to Individual Clinical Trials
- To support the clinical trials technicians and junior pharmacists as required in multidisciplinary team meetings with Investigators to initiate, manage and close down trials hence ensuring pharmacy participation.
- To assist the Clinical Trials and Quality Assurance Pharmacy Team Manager in the coordination of clinical trial set ups and to actively set up, review and sign off clinical trials.
- To audit documentation and processes for individual clinical trials.
- To ensure the appropriate disposal of unwanted trial materials.
- To support the development of a scheduling system for clinical trials.
- To liaise with the Specialist Clinical Pharmacists when approving or initiating new projects.
- To act as a source of Research expertise to advice on complex issues such as trial design, procurement, randomisation, blinding, documentation for in-house clinical trials and to defend / justify the opinions or decisions if the advice is challenged.
- To provide support and guidance on, and to participate in the costing and invoicing of clinical trials and ensure appropriate systems are in place.
Clinical Practice Role - (as clinical trial workload and priorities allow)
- To maintain clinical expertise and develop particular areas of interest as appropriate and in accordance with the Trust and Pharmacy strategy.
- To provide a ward-based clinical pharmacy service according to Trust agreed standards including:
- Individual prescription review to optimise therapy
- Confirmation of the patients medication history
- Advice on dosage, side-effects, cautions and monitoring required
- Advise on administration of medicines
- Appropriate and clear endorsing of prescriptions to ensure safe practice
- Monitor the effect and appropriateness of medication
- Education of patients on their medication
- Involvement in discharge planning and provision of discharge medication
- Use non-medical prescribing skills and qualifications, if applicable
3. To provide clinical pharmacy cover to other ward areas within the team on a reciprocal basis.
4. To ensure medicines are used appropriately, safely and cost-effectively in accordance with Trust policy, standard operating procedures and medicines legislation.
5. To monitor medicines use within the ward area. This includes recording of significant clinical interventions and risk management including:
- Participation in investigating clinical incidents
- Recording significant clinical incidents/near misses
- Ensuring compliance with medicines legislation and local policies
6. To use available information to influence prescribers and ensure the most cost-effective choice of therapy.
7. If already accredited, to be involved in a pharmacist led outpatient clinic as a non-medical prescriber if required by the clinical area and agreed by your line manager.
8. To contribute to the monitoring of safe, effective and economic use of medicines in the directorate in accordance with national and local guidelines, working with the Pharmacist Team Manager and Medicines Effectiveness Pharmacist.
9. To develop good working relationships and communication with clinical and managerial staff within area of specialist practice and provide a link regarding all aspects of the Pharmacy Service and Medicines Management.
10. To support the appropriate management of clinical trials and unlicensed medicines.
11. To support the implementation of medicines related policies such as reuse of patients own medicines, green bags etc across the Directorate.
12. To be aware of developments within own area of practice, the Directorate and Pharmacy/Medicines Management in general to develop own area of specialist practice, to share good practice and act as a resource.
13. To act as a role model and mentor for clinical pharmacy.
14. To be aware of Medicines Management/Medicines Safety issues for clinical area/directorate and where appropriate pharmacy, to ensure incident forms are completed, risk assessments are undertake and any learning is implemented and shared.
15. To develop personal practice research in accordance with the Trust and pharmacy strategy.
16. To contribute to local, national and international specialist interest groups and conferences/meetings as required.
17. To provide teaching for the pharmacy and directorate teams as required.
18. To act as knowledge base/resource for the specialist area and to keep up to date with current trends and research in the specialist area.
19. With the rest of the members of the clinical pharmacy team to support the strategic developments of the service e.g. electronic prescribing, improved discharge processes, accredited technician checking etc.
20. Actively contribute to the planning and efficient co-ordination of clinical pharmacy initiatives including discharge planning, prescribing protocols, pharmacists on consultant ward rounds etc.
21. To contribute to and implement the clinical governance plans of the clinical area and the pharmacy clinical governance plans.
Lead Pharmacist, Clinical Trials Role
- To manage the Clinical Trials Pharmacy Team in the absence of the Clinical Trials and Quality Assurance Pharmacy Team Manager.
- To deputise for the Clinical Trials and Quality Assurance Pharmacy Team Manager at e.g. Pharmacy or Directorate Meetings in the absence of or at the request of the Clinical Trials and Quality Assurance Pharmacy Team Manager or Pharmacy Clinical Services Manager or Chief pharmacist.
- To manage a group of staff within the team.
Professional Role:
- To ensure confidentiality is maintained at all times
- To be professionally accountable for actions and advice
- To use experience and clinical judgment to assist in problem-solving and trouble-shooting within the Pharmacy department.
- To give professional support to the site operational managers.
- To be aware of training and competency assessment of pre-registration pharmacist trainees, diploma pharmacists and student pharmacy technicians and participate in their training and competency assessment as required.
- To support the dispensaries by screening, dispensing and checking clinical trial prescriptions as needed.
- To support the Clinical Trials Aseptic Unit in the releasing of aseptically prepared doses and other activities required by the Unit as needed and to maintain competency.
- To participate in weekend and bank holiday working according to rota.
- Any other reasonable duties as requested by the Chief Pharmacist
Person Specification
Lead Pharmacist Clinical Trials
Essential
- Qualified to Pharmacy masters degree level (4 year MPharm) or equivalent
- Member of the Royal Pharmaceutical Society (MRPharmS)
- Postgraduate Diploma in Clinical Pharmacy or equivalent experience
- Experience of working as a clinical pharmacist at a high level in a variety of clinical areas
- Experience of working with Clinical Trials
- Problem identification and solving skills with an ability to prioritise effectively
- Ability to make decisions
- Well organised
- Good Time Management skills
- Good written and oral communication skills
- Good interpersonal skills including being assertive
- Professional and personal integrity
- Contributing to publications / conference presentations at least at a regional level
- Evidence of contribution to regional specialist interest groups
- Experience of working in a multidisciplinary team
- Demonstrable awareness of key drivers for the NHS
- Demonstrable awareness of financial pressures/constraints within the NHS
- Experience of developing drug protocols / contributing to formulary development
- Involvement in developing a service within pharmacy
- Experience of under-taking and supervising audits or drug use evaluations
- Ability to work in a team as well as autonomously and can delegate authority appropriately
- Must demonstrate flexibility in working practices
- Experience of teaching and tutoring
- Enthusiastic and self-motivated
- Capable of working under pressure
- Must show commitment
Desirable
- Management and/or Leadership qualifications or courses
- Membership of regional/national/international specialist interest group
- MSc in Clinical pharmacy
- Involvement in a pharmacist led outpatient clinic as a non-medical prescriber
- Contributing to publications / conference presentations at national/international level.
- Evidence of contribution to national/international specialist interest groups
- Experience of preparing budgetary reports for clinical areas
- Involvement of developing a multi-disciplinary service
- Experience of under-taking practice research
- Experience on line-managing staff
Person Specification
Lead Pharmacist Clinical Trials
Essential
- Qualified to Pharmacy masters degree level (4 year MPharm) or equivalent
- Member of the Royal Pharmaceutical Society (MRPharmS)
- Postgraduate Diploma in Clinical Pharmacy or equivalent experience
- Experience of working as a clinical pharmacist at a high level in a variety of clinical areas
- Experience of working with Clinical Trials
- Problem identification and solving skills with an ability to prioritise effectively
- Ability to make decisions
- Well organised
- Good Time Management skills
- Good written and oral communication skills
- Good interpersonal skills including being assertive
- Professional and personal integrity
- Contributing to publications / conference presentations at least at a regional level
- Evidence of contribution to regional specialist interest groups
- Experience of working in a multidisciplinary team
- Demonstrable awareness of key drivers for the NHS
- Demonstrable awareness of financial pressures/constraints within the NHS
- Experience of developing drug protocols / contributing to formulary development
- Involvement in developing a service within pharmacy
- Experience of under-taking and supervising audits or drug use evaluations
- Ability to work in a team as well as autonomously and can delegate authority appropriately
- Must demonstrate flexibility in working practices
- Experience of teaching and tutoring
- Enthusiastic and self-motivated
- Capable of working under pressure
- Must show commitment
Desirable
- Management and/or Leadership qualifications or courses
- Membership of regional/national/international specialist interest group
- MSc in Clinical pharmacy
- Involvement in a pharmacist led outpatient clinic as a non-medical prescriber
- Contributing to publications / conference presentations at national/international level.
- Evidence of contribution to national/international specialist interest groups
- Experience of preparing budgetary reports for clinical areas
- Involvement of developing a multi-disciplinary service
- Experience of under-taking practice research
- Experience on line-managing staff
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).
