Job summary
A collaborative model of research delivery has been agreed and Velindre University NHS Trust (VUNHST) has collaborated with Health and Care Research Wales and BioNTech, pharmaceutical company, to deliver the BioNTech clinical trial portfolio, which includes new advanced therapies such as mRNA cancer vaccine studies and other immunotherapeutic Clinical Trials of Investigative Medicinal Products (CTIMPs).
This exciting role will provide management oversite at 2 research delivery sites, managing a highly skilled team delivering cutting-edge new research.
To be successful in this role you need to be experienced in clinical research, and have proven management skills. You need to demonstrate excellent leadership qualities, communication and organisational skills and have a comprehensive knowledge of the ethical, financial, organisational and regulatory environment in which clinical research is delivered.
This post is Fixed Term or Secondment for up to 24 months, to meet the needs of the service.
If you are interested in applying for the secondment position, you must obtain permission from your current line manager prior to applying.
Main duties of the job
Provide nurse management oversite to support the delivery of new novel cancer therapies including advanced therapies such as mRNA cancer vaccine studies and other immunotherapeutic Clinical Trials.
Manage the trials within the Multidisciplinary Team
Supervise, advise and develop a research team.
Deputise for Band 8a in their absence.
The ability to speak Welsh is desirable for this post; Welsh and/or English speakers are equally welcome to apply.
About us
Here at Velindre University NHS Trust we are extremely proud of the specialist services we provide across the whole of Wales in our cutting-edge Velindre Cancer Centre and ouraward-winning Welsh Blood Service, as well as the expertise of our corporate functions that bring the two divisions together. We are also fortunate to host the NHS Wales Shared Services Partnership and Health Technology Wales and have developed strong partnership working with these expert services.
Formed in 1999, the Trust has a dedicated workforce that continuously strives to apply the key principles of value based healthcare through a wide array of roles. We play a vital role in the communities we support and have ambitious plans for the future to continue to improve the services we deliver. We strive to maintain our core values in everything we do by being; accountable, bold, caring and dynamic, and ensuring the best possible care for our patients and donors.
If you want to work for an organisation that prides itself on making a real difference and offers exciting career opportunities then Velindre University NHS Trust is the place for you.
Visit our website to find out more https://velindre.nhs.wales/
Job description
Job responsibilities
Communicate competently complex information about specific clinical trials and their consequences, to patients and carers ensuring they have a good understanding of treatment options, thereby ensuring high standards of informed consent.
To act as the key worker for patients in your direct care for the duration of active involvement in a clinical trial, ensuring that all patients, carers and appropriate community colleagues are well informed about their disease and its management, providing appropriate and timely information.
Work in partnership with clinical investigators with all aspects of a clinical trial, including: trial set up, trial documentation, data collection, administration and patient recruitment and treatment coordination.
Registered general nurse / practitioner with evidence of highly developed knowledge in oncology and clinical research to include well developed leadership and managerial skills.
Educated to Masters level or equivalent experience or qualification.
Takes personal responsibility for lifelong learning and personal development through clinical supervision, appraisal and knowledge and skills framework, actively engaging with learning and development opportunities in response to emerging knowledge and techniques.
Work autonomously to manage a large caseload of patients acting as a professional nurse in ensuring a duty of care to the patient and their families.
To be able to provide an expert opinion on the creation and coordination of the disease specific portfolio in collaboration with the MDT.
Judgements on information giving for conflicting studies.
Assessing the feasibility of running a trial in VUNHST and CVUHB.
Participate in service reviews in order to instigate and manage change and service improvement within a complex department.
Influence and develop policy and clinical guidelines internally and externally.
Lead on the contribution to the early phase service development, ensuring pursuit of excellence in care for trials patients.
Work with the R&D Delivery Manager, and RD& I finance Manager in assessing the financial impact to the Trust and CVUHB of commercial and non-commercial trials.
Financial Initiative Deal with financial negotiations and contractual agreements with pharmaceutical companies when setting up a clinical trial.
Identify and discuss with individual departments the physical resource implications.
Mentor new research staff and provide training in own discipline and that of other Clinical Trials Unit posts of Band 6 and below as required.
Managing and supervising an early phase team. Implementing annual PADRs
Ensure continued effective registration with the NMC and be aware of NMC Code of Professional Conduct. They must be accountable for their own practice. Work within the NMC Scope of Professional Practice and ensure competency to undertake duties as allocated.
To be responsible for initiating and coordinating a range of UK, European and World Wide cancer trials for VUNHST and CVUHB as required, in collaboration with the relevant multi-disciplinary research teams.
To ensure that as an individual and as a team lead a quality service is delivered maintaining safety of the patient, and working to WG national research KPI`s.
Request trial related radiological procedures
Clinical assessment of patient.
Use of ECGs Blood pressure machines and other equipment required to monitor the patient.
Knowledge of trial SACT.
Job description
Job responsibilities
Communicate competently complex information about specific clinical trials and their consequences, to patients and carers ensuring they have a good understanding of treatment options, thereby ensuring high standards of informed consent.
To act as the key worker for patients in your direct care for the duration of active involvement in a clinical trial, ensuring that all patients, carers and appropriate community colleagues are well informed about their disease and its management, providing appropriate and timely information.
Work in partnership with clinical investigators with all aspects of a clinical trial, including: trial set up, trial documentation, data collection, administration and patient recruitment and treatment coordination.
Registered general nurse / practitioner with evidence of highly developed knowledge in oncology and clinical research to include well developed leadership and managerial skills.
Educated to Masters level or equivalent experience or qualification.
Takes personal responsibility for lifelong learning and personal development through clinical supervision, appraisal and knowledge and skills framework, actively engaging with learning and development opportunities in response to emerging knowledge and techniques.
Work autonomously to manage a large caseload of patients acting as a professional nurse in ensuring a duty of care to the patient and their families.
To be able to provide an expert opinion on the creation and coordination of the disease specific portfolio in collaboration with the MDT.
Judgements on information giving for conflicting studies.
Assessing the feasibility of running a trial in VUNHST and CVUHB.
Participate in service reviews in order to instigate and manage change and service improvement within a complex department.
Influence and develop policy and clinical guidelines internally and externally.
Lead on the contribution to the early phase service development, ensuring pursuit of excellence in care for trials patients.
Work with the R&D Delivery Manager, and RD& I finance Manager in assessing the financial impact to the Trust and CVUHB of commercial and non-commercial trials.
Financial Initiative Deal with financial negotiations and contractual agreements with pharmaceutical companies when setting up a clinical trial.
Identify and discuss with individual departments the physical resource implications.
Mentor new research staff and provide training in own discipline and that of other Clinical Trials Unit posts of Band 6 and below as required.
Managing and supervising an early phase team. Implementing annual PADRs
Ensure continued effective registration with the NMC and be aware of NMC Code of Professional Conduct. They must be accountable for their own practice. Work within the NMC Scope of Professional Practice and ensure competency to undertake duties as allocated.
To be responsible for initiating and coordinating a range of UK, European and World Wide cancer trials for VUNHST and CVUHB as required, in collaboration with the relevant multi-disciplinary research teams.
To ensure that as an individual and as a team lead a quality service is delivered maintaining safety of the patient, and working to WG national research KPI`s.
Request trial related radiological procedures
Clinical assessment of patient.
Use of ECGs Blood pressure machines and other equipment required to monitor the patient.
Knowledge of trial SACT.
Person Specification
Qualifications and Knowledge
Essential
- 1st level registered nurse or professional health care equivalent.
- Masters degree or equivalent experience or qualification.
- Evidence of continued professional development
- Working knowledge of G.C.P and its application in the NHS research environment,
Desirable
- Clinical Research Qualification.
- Teaching qualification
- ECDL
Experience
Essential
- Experience as a specialist nurse.
- Experience of caring for patients within the research setting.
Desirable
- Experience of caring for patients in the Cancer setting
- Phase 1 trial experience.
- Clinical skills in delivering novel early phase therapies.
Skills and Attributes
Essential
- Ability to work on own initiative
- Excellent communication skills
- Computing skills
- Good patient advocate
- Teaching and presentation skills
- Counselling skills
- Knowledge of the research process and regulatory requirements - G.C.P and research governance.
- Knowledge of MS Office application and E-mail
- Ability to work autonomously and as part of a Team
- Enthusiastic and motivated
- Attention to detail
Other
Essential
- Ability to travel, in the course of duties
- Flexible approach to working hours according to service needs
Desirable
- Welsh Speaker (Level 1) or willingness to work towards
Person Specification
Qualifications and Knowledge
Essential
- 1st level registered nurse or professional health care equivalent.
- Masters degree or equivalent experience or qualification.
- Evidence of continued professional development
- Working knowledge of G.C.P and its application in the NHS research environment,
Desirable
- Clinical Research Qualification.
- Teaching qualification
- ECDL
Experience
Essential
- Experience as a specialist nurse.
- Experience of caring for patients within the research setting.
Desirable
- Experience of caring for patients in the Cancer setting
- Phase 1 trial experience.
- Clinical skills in delivering novel early phase therapies.
Skills and Attributes
Essential
- Ability to work on own initiative
- Excellent communication skills
- Computing skills
- Good patient advocate
- Teaching and presentation skills
- Counselling skills
- Knowledge of the research process and regulatory requirements - G.C.P and research governance.
- Knowledge of MS Office application and E-mail
- Ability to work autonomously and as part of a Team
- Enthusiastic and motivated
- Attention to detail
Other
Essential
- Ability to travel, in the course of duties
- Flexible approach to working hours according to service needs
Desirable
- Welsh Speaker (Level 1) or willingness to work towards
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).
