Specialist Clinical Trials Pharmacist Clinical Trials: Cancer
Nottingham University Hospitals NHS Trusts
This job is now closed
Job summary
Passionate about innovation in cancer treatments?
Thinking about including experience in clinical research in your career?
This post is a great opportunity to be part of a dedicated pharmacy clinical trials team delivering a high quality and responsive service to patients, clinical staff and sponsors who use our services in adult cancer research.
Main duties of the job
In addition to the below summary you need to familiarise yourself with full job description and person specification documents attached to this advert.
You will be the pharmacy lead for adult cancer clinical trials, responsible for appraisal of all relevant clinical trials including costing and all aspects of pharmaceutical input in accordance with legal requirements and Good Clinical Practice relating to the prescribing, handling, dispensing, administration, storage and disposal of investigational medicinal products (IMPs) and non investigational medicinal products (NIMPs).
You will advise and work with the chemotherapy production unit team with regard to issues relating to Good Manufacturing Practice and clinical trials in adult cancer and contribute to the delivery of a high quality specialist clinical pharmacy service to adult cancer.
You will be based on the City Campus with some cross-town working as required to meet the demands of the pharmacy trials service.
You will be responsible for individual portfolio of cancer clinical trials, with the expectation of close working and cross-cover, as required with your specialist cancer clinical trials pharmacists colleagues.
About us
NUH is an acute care, research active teaching hospital who in partnership with Nottingham University hosts a Biomedical Research Centre and Clinical Research Facility conducting research into hearing, digestive, respiratory and musculoskeletal disease, mental health and imaging.
NUH recognises the vital role pharmacy has in the management of robust clinical research and NUH Research and Innovation department supports a number of our posts to ensure we can deliver a safe, efficient and responsive clinical trials service.
You will have a close working relationship with all members of the pharmacy trials team of pharmacists, technicians and assistants and have regular contact with clinical research staff and Pharmaceutical companies
NUH has a nationally-recognised staff wellbeing programme and as recently voted as one of the Sunday Times Best Places to live, our city and the region are one of the big reasons why a career at NUH is the right choice for so many. The city has been named in the top ten places to bring up a family and the top UK city to make your salary stretch further.
For further information or an informal chat please contact the current post holder Chris Pudney by phone on 01159691169 ext 79414 or christopher.pudney@nuh.nhs.uk
Date posted
20 March 2024
Pay scheme
Agenda for change
Band
Band 8a
Salary
£50,952 to £57,349 a year per annum
Contract
Fixed term
Duration
14 months
Working pattern
Full-time
Reference number
164-6141953
Job locations
Nottingham University Hospitals NHS Trust
Nottingham
NG5 1PB
Job description
Job responsibilities
JOB SUMMARY
To be a pharmacy lead to a portfolio of cancer clinical trials. To be responsible for appraisal of all relevant clinical trials including costing and all aspects of pharmaceutical input in accordance with legal requirements and Good Clinical Practice (GCP) relating to the prescribing, handling, dispensing, administration, storage and disposal of investigational medicinal products (IMPs) and non-investigational medicinal products (NIMPs).
To advise and work with the chemotherapy production unit team with regard to issues relating to Good Manufacturing Practice and cancer trials.
To contribute to the delivery of a high quality specialist clinical pharmacy service to cancer clinical services.
The post holders will be based at City Campus; cross-town working will be required.
The post holder will be responsible for individual portfolio of cancer clinical trials; there is an expectation of close working and cross-cover, with cancer clinical trial pharmacists colleagues as required.
KEY JOB RESPONSIBILITIES
Service Management and Development
1. Takes responsibility for the delivery, management and development of the pharmacy clinical trials service in cancer.
1.1. Attends specialty clinical trials meetings as appropriate.
1.2. In co-operation with the Research teams, Senior Cancer Services Pharmacists and Principal Pharmacist Research and Innovative Treatments, identifies and prioritises clinical trial pharmacy services in cancer to ensure national and local agendas are delivered.
1.3. Develops, implements and audits pharmacy clinical trials practices with regards to clinical haematology/ oncology.
1.4. Liaises with Cancer trials pharmacists across the East Midlands Cancer Alliance and wider where appropriate, to share working and work towards equity of care with regards to cancer clinical trials across the network. Participates in the Regional Clinical Trials Pharmacists Group meetings when required.
1.5. Provides expert advice regarding cancer trials to the Pharmacy Department, the relevant specialties, consultant teams, research teams and other clinical specialities as required.
1.6. Supports the maintenance and use of the chemotherapy e-prescribing system (Chemocare). This includes set-up and validation of new medicines, chemotherapy and trials regimens, and up-date of existing medicines and regimens.
2. Supports the Principal Pharmacist Research and Innovative Treatments in specific cancer clinical trials management issues and projects.
3. Participates and supports the development of business plans and department and clinical strategies, e.g. in response to expansion of services, new consultant appointments, national initiatives and locally identified risks.
4. Contributes to the overall organisation, administration and management of the Pharmacy Clinical Trials and Cancer Services teams.
Clinical Trials Service (80%)
5. Takes responsibility for the provision, management and development of a high quality, comprehensive specialist clinical trials pharmacy service.
5.1. Works according to GCP guidelines and agreed pharmacy clinical trials procedures.
5.2. Critically appraises cancer clinical trials protocols, including amendments, to assess feasibility and ensure all pharmaceutical aspects of the study are deliverable and safe, in liaison with the chemotherapy production unit staff as required.
5.3. Calculates pharmacy support costs for cancer clinical trials protocols, liaising with the speciality research teams, sponsors and NUH Research and Innovation (R&I) Department.
5.4. Pro-actively costs for medicine-savings and cost-avoidance for all patients recruited to cancer clinical trials.
5.5. Liaises with NUH R&I and research teams, to ensure timely appraisal, costing and pharmacy approval for cancer clinical trials.
5.6. Leads and finalises the set-up of cancer clinical trials, i.e. writing and/or checking dispensing procedure, trials specific Chemocare prescriptions and worksheets.
5.7. Is accountable for adherence to protocol requirements for investigational medicinal product (IMP) management for cancer trials.
5.8 Facilitates the Principal Pharmacist for Research and Innovative services in the development of new services to deliver novel and innovative therapies to patients with the research setting.
6. Participates in the provision of a clinical pharmacy service for cancer patients recruited into clinical trials within the Trust
6.1. Assesses and clinically verifies trial specific prescriptions to ensure safe and rational prescribing according to the study protocol
6.2. Provides trial medication and any additional supporting treatment for inpatient, discharge or outpatient use.
6.3. Counsels patients to ensure medication usage according to the protocol and to improve patient understanding of medication using trial specific patient information.
6.4. Assesses patient compliance via review of trial medication returned by trial subjects and patient counselling
6.5. Contributes to detection of possible adverse events and prompt notification of the investigator and sponsor, where relevant
6.6. Accuracy checks prescriptions, dispensed by others, for accuracy of interpretation, supply, labelling and accountability recording.
Clinical Practice (20%)
7. Supports the provision, of a high quality, comprehensive specialist pharmacy service to Clinical Haematology
7.1. Demonstrates professional accountability to patients under their care.
7.2. Provides specialist advice and guidance on all issues relating to prescribing and therapeutics of drugs used within cancer services in line with national and local guidelines.
7.3. Uses specialist knowledge and experience, and appraises information from numerous sources to provide highly specialised advice on drug therapy to medical, nursing and pharmacy staff. This may include advice about experimental medicines or of medicine use where limited evidence exists.
7.4. Assesses and verifies prescription and charts and prescribing, including chemotherapy, in order to ensure safe, rational and effective prescribing within existing guidelines.
7.5. Identifies potential adverse reactions to medicines, drug interactions and intravenous drug compatibility issues.
7.6. Establishes drug histories and enables the use of patients own medicines.
7.7. Counsels patients on their drug therapy to improve medication usage and patient understanding of their medication during in-patient stay and after discharge.
7.8. Provides medications for individual patients during their stay in hospital and at discharge as necessary.
7.9. Requests and interprets clinical tests and serum drug levels to monitor and make recommendations to improve effectiveness of drug therapy.
7.10. Pro-actively liaises with other members of the multidisciplinary team in order to make recommendations about drug therapy to improve patient outcomes.
7.11. Encourages and monitors adherence to hospital formulary, chemotherapy protocols and national guidelines.
7.12. Amends prescriptions on verbal orders from prescribers and transcribes prescriptions for patients being discharged.
7.13. Is accountable on the clinical areas served (wards and clinics) for adherence to all pharmacy policies and procedures relating to medicines management.
8. Works with the other pharmacists in the provision of a high quality clinical pharmacy service to wards in the hospital as directed by the Assistant Head of Pharmacy - Clinical Services Lead and the Team leader for Cancer services.
9. Provides professional supervision in the dispensary and chemotherapy production unit by:
9.1. Final checking and release of manufactured/dispensed chemotherapy, in accordance with good manufacturing practice and departmental procedures.
9.2. Accurately interpreting and clinically screening chemotherapy prescriptions, referring to relevant chemotherapy protocols and intervening when necessary.
9.3. Screening, checking and release to designated clinical areas, of intrathecal chemotherapy in accordance with Trust and Department of Health policies and procedures.
Financial Resource Management
10. Calculates the cost of pharmacy support for Clinical Haematology cancer clinical trials protocols, liaising with the specialty research teams, sponsors and NUH R&I Department where NUH is the chief investigator site.
11. Identifies potential cost savings and/or efficiency initiatives in medicines usage, relevant to clinical trials.
12. Ensures trials fees are invoiced and reclaim mechanisms for the medicine costs are accounted for and implemented, liaising with the Specialist Pharmacist High-Cost Drugs Management.
Human Resource Management
- Acts as a role model
- Supervises and teaches junior staff (rotational and diploma pharmacists, technicians, pre-registration pharmacists, pharmacy students)
- Leads on the submission of business cases to secure funding for service developments/new pharmacy posts within the specialty, in liaison with the team leader.
- Assists in the recruitment of new staff.
- Contributes to the performance and line management of pharmacy staff working within the Cancer Services and Clinical trials teams, including appraisals.
Research and Development
- Undertakes, supervises and participates in research, and if suitable registers for a further degree (e.g. DPharm, MPhil).
- Actively evaluates and integrates research evidence into practice to develop and improve pharmacy services within the directorate and the department.
- Maintains contact with appropriate national and local specialist groups to facilitate best practice to be identified and incorporated into NUH practice.
Job description
Job responsibilities
JOB SUMMARY
To be a pharmacy lead to a portfolio of cancer clinical trials. To be responsible for appraisal of all relevant clinical trials including costing and all aspects of pharmaceutical input in accordance with legal requirements and Good Clinical Practice (GCP) relating to the prescribing, handling, dispensing, administration, storage and disposal of investigational medicinal products (IMPs) and non-investigational medicinal products (NIMPs).
To advise and work with the chemotherapy production unit team with regard to issues relating to Good Manufacturing Practice and cancer trials.
To contribute to the delivery of a high quality specialist clinical pharmacy service to cancer clinical services.
The post holders will be based at City Campus; cross-town working will be required.
The post holder will be responsible for individual portfolio of cancer clinical trials; there is an expectation of close working and cross-cover, with cancer clinical trial pharmacists colleagues as required.
KEY JOB RESPONSIBILITIES
Service Management and Development
1. Takes responsibility for the delivery, management and development of the pharmacy clinical trials service in cancer.
1.1. Attends specialty clinical trials meetings as appropriate.
1.2. In co-operation with the Research teams, Senior Cancer Services Pharmacists and Principal Pharmacist Research and Innovative Treatments, identifies and prioritises clinical trial pharmacy services in cancer to ensure national and local agendas are delivered.
1.3. Develops, implements and audits pharmacy clinical trials practices with regards to clinical haematology/ oncology.
1.4. Liaises with Cancer trials pharmacists across the East Midlands Cancer Alliance and wider where appropriate, to share working and work towards equity of care with regards to cancer clinical trials across the network. Participates in the Regional Clinical Trials Pharmacists Group meetings when required.
1.5. Provides expert advice regarding cancer trials to the Pharmacy Department, the relevant specialties, consultant teams, research teams and other clinical specialities as required.
1.6. Supports the maintenance and use of the chemotherapy e-prescribing system (Chemocare). This includes set-up and validation of new medicines, chemotherapy and trials regimens, and up-date of existing medicines and regimens.
2. Supports the Principal Pharmacist Research and Innovative Treatments in specific cancer clinical trials management issues and projects.
3. Participates and supports the development of business plans and department and clinical strategies, e.g. in response to expansion of services, new consultant appointments, national initiatives and locally identified risks.
4. Contributes to the overall organisation, administration and management of the Pharmacy Clinical Trials and Cancer Services teams.
Clinical Trials Service (80%)
5. Takes responsibility for the provision, management and development of a high quality, comprehensive specialist clinical trials pharmacy service.
5.1. Works according to GCP guidelines and agreed pharmacy clinical trials procedures.
5.2. Critically appraises cancer clinical trials protocols, including amendments, to assess feasibility and ensure all pharmaceutical aspects of the study are deliverable and safe, in liaison with the chemotherapy production unit staff as required.
5.3. Calculates pharmacy support costs for cancer clinical trials protocols, liaising with the speciality research teams, sponsors and NUH Research and Innovation (R&I) Department.
5.4. Pro-actively costs for medicine-savings and cost-avoidance for all patients recruited to cancer clinical trials.
5.5. Liaises with NUH R&I and research teams, to ensure timely appraisal, costing and pharmacy approval for cancer clinical trials.
5.6. Leads and finalises the set-up of cancer clinical trials, i.e. writing and/or checking dispensing procedure, trials specific Chemocare prescriptions and worksheets.
5.7. Is accountable for adherence to protocol requirements for investigational medicinal product (IMP) management for cancer trials.
5.8 Facilitates the Principal Pharmacist for Research and Innovative services in the development of new services to deliver novel and innovative therapies to patients with the research setting.
6. Participates in the provision of a clinical pharmacy service for cancer patients recruited into clinical trials within the Trust
6.1. Assesses and clinically verifies trial specific prescriptions to ensure safe and rational prescribing according to the study protocol
6.2. Provides trial medication and any additional supporting treatment for inpatient, discharge or outpatient use.
6.3. Counsels patients to ensure medication usage according to the protocol and to improve patient understanding of medication using trial specific patient information.
6.4. Assesses patient compliance via review of trial medication returned by trial subjects and patient counselling
6.5. Contributes to detection of possible adverse events and prompt notification of the investigator and sponsor, where relevant
6.6. Accuracy checks prescriptions, dispensed by others, for accuracy of interpretation, supply, labelling and accountability recording.
Clinical Practice (20%)
7. Supports the provision, of a high quality, comprehensive specialist pharmacy service to Clinical Haematology
7.1. Demonstrates professional accountability to patients under their care.
7.2. Provides specialist advice and guidance on all issues relating to prescribing and therapeutics of drugs used within cancer services in line with national and local guidelines.
7.3. Uses specialist knowledge and experience, and appraises information from numerous sources to provide highly specialised advice on drug therapy to medical, nursing and pharmacy staff. This may include advice about experimental medicines or of medicine use where limited evidence exists.
7.4. Assesses and verifies prescription and charts and prescribing, including chemotherapy, in order to ensure safe, rational and effective prescribing within existing guidelines.
7.5. Identifies potential adverse reactions to medicines, drug interactions and intravenous drug compatibility issues.
7.6. Establishes drug histories and enables the use of patients own medicines.
7.7. Counsels patients on their drug therapy to improve medication usage and patient understanding of their medication during in-patient stay and after discharge.
7.8. Provides medications for individual patients during their stay in hospital and at discharge as necessary.
7.9. Requests and interprets clinical tests and serum drug levels to monitor and make recommendations to improve effectiveness of drug therapy.
7.10. Pro-actively liaises with other members of the multidisciplinary team in order to make recommendations about drug therapy to improve patient outcomes.
7.11. Encourages and monitors adherence to hospital formulary, chemotherapy protocols and national guidelines.
7.12. Amends prescriptions on verbal orders from prescribers and transcribes prescriptions for patients being discharged.
7.13. Is accountable on the clinical areas served (wards and clinics) for adherence to all pharmacy policies and procedures relating to medicines management.
8. Works with the other pharmacists in the provision of a high quality clinical pharmacy service to wards in the hospital as directed by the Assistant Head of Pharmacy - Clinical Services Lead and the Team leader for Cancer services.
9. Provides professional supervision in the dispensary and chemotherapy production unit by:
9.1. Final checking and release of manufactured/dispensed chemotherapy, in accordance with good manufacturing practice and departmental procedures.
9.2. Accurately interpreting and clinically screening chemotherapy prescriptions, referring to relevant chemotherapy protocols and intervening when necessary.
9.3. Screening, checking and release to designated clinical areas, of intrathecal chemotherapy in accordance with Trust and Department of Health policies and procedures.
Financial Resource Management
10. Calculates the cost of pharmacy support for Clinical Haematology cancer clinical trials protocols, liaising with the specialty research teams, sponsors and NUH R&I Department where NUH is the chief investigator site.
11. Identifies potential cost savings and/or efficiency initiatives in medicines usage, relevant to clinical trials.
12. Ensures trials fees are invoiced and reclaim mechanisms for the medicine costs are accounted for and implemented, liaising with the Specialist Pharmacist High-Cost Drugs Management.
Human Resource Management
- Acts as a role model
- Supervises and teaches junior staff (rotational and diploma pharmacists, technicians, pre-registration pharmacists, pharmacy students)
- Leads on the submission of business cases to secure funding for service developments/new pharmacy posts within the specialty, in liaison with the team leader.
- Assists in the recruitment of new staff.
- Contributes to the performance and line management of pharmacy staff working within the Cancer Services and Clinical trials teams, including appraisals.
Research and Development
- Undertakes, supervises and participates in research, and if suitable registers for a further degree (e.g. DPharm, MPhil).
- Actively evaluates and integrates research evidence into practice to develop and improve pharmacy services within the directorate and the department.
- Maintains contact with appropriate national and local specialist groups to facilitate best practice to be identified and incorporated into NUH practice.
Person Specification
Training and Qualifications
Essential
- BPharm/BSc or MPharm/MSc or equivalent
- Current General Pharmaceutical Council registration
- Member of the RPharmS.
- Diploma/MSc in Clinical Pharmacy, or relevant postgraduate experience
- Awareness of Good Clinical Practice (GCP)
Desirable
- Current GCP certification.
Experience
Essential
- Experience of specialist clinical pharmacy service delivery to cancer patients
- Experience of working with chemotherapy e-prescribing systems
- Awareness of specialist clinical trials service delivery in pharmacy, i.e. clinical trial appraisal, set-up, IMP supply and trial maintenance
- Comprehensive knowledge and understanding of the formulation, preparation, therapeutic action of medicines, particularly anticancer medicines (including cytotoxic chemotherapy)
Desirable
- Experience in validating chemotherapy e-prescribing protocols
- Experience of specialist clinical trials service delivery in pharmacy.
- Understanding of commissioning routes for cancer patients
Communication and relationship skills
Essential
- Strong, accurate and concise written and oral communication skills, including presentation skills
- Able to receive, interpret, summarise, communicate and present complex information to a wide range of professionals across the Trust
- Effective independent and team working skills
Analytical and Judgement skills
Essential
- Able to apply specialist clinical knowledge to interpret and appraise complex cancer clinical trials protocols and resolve issues relating to pharmaceutical aspects of the protocol.
- Able to find, analyse and interpret wide range of clinical information
Planning and organisation skills
Essential
- Able to prioritise, plan, co-ordinate, develop and adjust pharmacy clinical trials services
- Able to work effectively to short, medium, long-term and changing deadlines
- Able to plan, organise and manage own workloads and that of others
Person Specification
Training and Qualifications
Essential
- BPharm/BSc or MPharm/MSc or equivalent
- Current General Pharmaceutical Council registration
- Member of the RPharmS.
- Diploma/MSc in Clinical Pharmacy, or relevant postgraduate experience
- Awareness of Good Clinical Practice (GCP)
Desirable
- Current GCP certification.
Experience
Essential
- Experience of specialist clinical pharmacy service delivery to cancer patients
- Experience of working with chemotherapy e-prescribing systems
- Awareness of specialist clinical trials service delivery in pharmacy, i.e. clinical trial appraisal, set-up, IMP supply and trial maintenance
- Comprehensive knowledge and understanding of the formulation, preparation, therapeutic action of medicines, particularly anticancer medicines (including cytotoxic chemotherapy)
Desirable
- Experience in validating chemotherapy e-prescribing protocols
- Experience of specialist clinical trials service delivery in pharmacy.
- Understanding of commissioning routes for cancer patients
Communication and relationship skills
Essential
- Strong, accurate and concise written and oral communication skills, including presentation skills
- Able to receive, interpret, summarise, communicate and present complex information to a wide range of professionals across the Trust
- Effective independent and team working skills
Analytical and Judgement skills
Essential
- Able to apply specialist clinical knowledge to interpret and appraise complex cancer clinical trials protocols and resolve issues relating to pharmaceutical aspects of the protocol.
- Able to find, analyse and interpret wide range of clinical information
Planning and organisation skills
Essential
- Able to prioritise, plan, co-ordinate, develop and adjust pharmacy clinical trials services
- Able to work effectively to short, medium, long-term and changing deadlines
- Able to plan, organise and manage own workloads and that of others
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.
Certificate of Sponsorship
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
Certificate of Sponsorship
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).
Employer details
Employer name
Nottingham University Hospitals NHS Trusts
Address
Nottingham University Hospitals NHS Trust
Nottingham
NG5 1PB
Employer's website
Employer details
Employer name
Nottingham University Hospitals NHS Trusts
Address
Nottingham University Hospitals NHS Trust
Nottingham
NG5 1PB
Employer's website
For questions about the job, contact:
Date posted
20 March 2024
Pay scheme
Agenda for change
Band
Band 8a
Salary
£50,952 to £57,349 a year per annum
Contract
Fixed term
Duration
14 months
Working pattern
Full-time
Reference number
164-6141953
Job locations
Nottingham University Hospitals NHS Trust
Nottingham
NG5 1PB
Supporting documents
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