Job summary
The Liverpool University Hospitals NHS Foundation Trust Clinical Research Facility (CRF) is a Phase 1 accredited unit, the first NHS trust in England and Wales to achieve this standard.
The facility undertakes and delivers clinical trials in patients and healthy volunteers with a particular emphasis on early phase research.
Patients and volunteers are seen in comfortable surroundings ultimately improving the experience for participants in Clinical Trials.
This is a band 5 Research Nurse post with the potential progression to a band 6, in accordance to Annex 20 Agenda for change.
The post holder must meet the band 6 competencies in order to move onto the Band 6 Job description.
Main duties of the job
The post holder will provide support with early phase clinical trials and work closely with the Operational team.
They will assist with all aspects of the planning, conduct and reporting of all clinical trials under supervision.
The post holder will assist the Clinicians in the assessment of patients/volunteers for eligibility for research and monitoring of their condition throughout their participation.
To undertake participant study visits, screening clinics and clinical trial procedure including coordinating special tests in other departments.
To carry out the collection, processing of samples according to protocol requirements.
To carry out treatment procedures and treatment interventions, including venepuncture, cannulation, ECGs, and vital sign recording.
To keep accurate records and prepare for audits and inspections.
To have an understanding of clinical research including ethics and drug development.
The post holder will ensure that all clinical research activity is ICH GCP compliant and conducted in accordance with the agreed protocols. They will maintain a high standard of patient care in line with Trust and R&D policies and protocols and in accordance with the Research Governance Framework.
The post does include shifts patterns including night shifts and weekends. The post holder will provide on call nursing cover outside of normal working hours for the CRF on occasion and by arrangement to assist and provide support to the CRF Physician on call.
About us
Liverpool University Hospitals NHS Foundation Trust was created on 1 October 2019 following the merger of two adult acute Trusts, Aintree University Hospital NHS Foundation Trust and the Royal Liverpool and Broadgreen University Hospitals NHS Trust.
The merger provides an opportunity to reconfigure services in a way that provides the best healthcare services to the city and improves the quality of care and health outcomes that patients experience.
The Trust runs Aintree University Hospital, Broadgreen Hospital, Liverpool University Dental Hospital and the Royal Liverpool University Hospital.
It serves a core population of around 630,000 people across Merseyside as well as providing a range of highly specialist services to a catchment area of more than two million people in the North West region and beyond.
To hear more about our achievements click herehttps://www.liverpoolft.nhs.uk/media/13089/1606-annual-report-booklet_final.pdf
Follow us on Social Media:
Facebook - Liverpool University Hospitals Careers
Instagram - @LUHFTcareers
Twitter - @LUHFTcareers
Job description
Job responsibilities
To assist with all aspects of the planning, conduct and reporting of all clinical trials within the research speciality under the supervision of a Registered Nurse (Band 6 and above)
To assist with the day to day management of research studies with supervision as part of a research team
To assist with recruitment targets under supervision of the Research Team
To ensure that all data is collected and managed accurately
To ensure that all clinical research activity is ICH GCP compliant and conducted in accordance with the agreed protocols
To maintain a high standard of patient care in line with Trust and R&D policies and protocols and in accordance with the Research Governance Framework
To assist the clinicians in the assessment of patients/volunteers for eligibility for research and monitoring of their condition throughout their participation.
To provide on-going advice and information to patients/volunteers with regard to their participation in clinical research in order to facilitate effective informed consent.
To assist with patient visits in accordance with study protocols, including co-ordinating special tests in other departments, collection of data, coding, data entry and patient support
To carry out treatment procedures and treatment interventions according to pre-determined protocols, including venepuncture, venous cannulation, administering of intra-venous drugs and vital sign recording
To carry out the collection, processing and shipping of biological specimens according to protocol requirements and follow up appropriately on alert values
To ensure that patient safety is paramount in all procedures that take place for trial purposes
To be responsible for the setting up of workbooks or other forms of capturing source data.
To be responsible for hosting Monitoring visits including ensuring that source data and Study Master Files are up to date and complete prior to each monitoring visit
To assist the clinicians to report and record any adverse events as dictated by Trust and Departmental protocols.
To ensure clinical and research documentation and record keeping is completed in a timely manner, accurately and efficiently in accordance with NMC and EU Directive (ICH GCP) Guidelines
To have computer skills for the handling and management of computerised data
To be aware of relevant medical literature, developments in clinical research methodology, monitoring and local regulatory and ethical requirements
To attend courses, research network meetings, conferences and study days in order to remain up to date with all relevant aspects of clinical research
To have an understanding to the relevance of research to health care delivery and to be aware of research problems with the speciality
To participate in the education and development of student nurses
It is anticipated that the individual post-holder will meet the following requirements of the post;
An interest in the research speciality is desirable
To possess computer skills
To have excellent interpersonal and communication skills
Effective time management skills
Competent in the skills of venepuncture and IV cannulation
Job description
Job responsibilities
To assist with all aspects of the planning, conduct and reporting of all clinical trials within the research speciality under the supervision of a Registered Nurse (Band 6 and above)
To assist with the day to day management of research studies with supervision as part of a research team
To assist with recruitment targets under supervision of the Research Team
To ensure that all data is collected and managed accurately
To ensure that all clinical research activity is ICH GCP compliant and conducted in accordance with the agreed protocols
To maintain a high standard of patient care in line with Trust and R&D policies and protocols and in accordance with the Research Governance Framework
To assist the clinicians in the assessment of patients/volunteers for eligibility for research and monitoring of their condition throughout their participation.
To provide on-going advice and information to patients/volunteers with regard to their participation in clinical research in order to facilitate effective informed consent.
To assist with patient visits in accordance with study protocols, including co-ordinating special tests in other departments, collection of data, coding, data entry and patient support
To carry out treatment procedures and treatment interventions according to pre-determined protocols, including venepuncture, venous cannulation, administering of intra-venous drugs and vital sign recording
To carry out the collection, processing and shipping of biological specimens according to protocol requirements and follow up appropriately on alert values
To ensure that patient safety is paramount in all procedures that take place for trial purposes
To be responsible for the setting up of workbooks or other forms of capturing source data.
To be responsible for hosting Monitoring visits including ensuring that source data and Study Master Files are up to date and complete prior to each monitoring visit
To assist the clinicians to report and record any adverse events as dictated by Trust and Departmental protocols.
To ensure clinical and research documentation and record keeping is completed in a timely manner, accurately and efficiently in accordance with NMC and EU Directive (ICH GCP) Guidelines
To have computer skills for the handling and management of computerised data
To be aware of relevant medical literature, developments in clinical research methodology, monitoring and local regulatory and ethical requirements
To attend courses, research network meetings, conferences and study days in order to remain up to date with all relevant aspects of clinical research
To have an understanding to the relevance of research to health care delivery and to be aware of research problems with the speciality
To participate in the education and development of student nurses
It is anticipated that the individual post-holder will meet the following requirements of the post;
An interest in the research speciality is desirable
To possess computer skills
To have excellent interpersonal and communication skills
Effective time management skills
Competent in the skills of venepuncture and IV cannulation
Person Specification
Qualifications
Essential
- Registered Nurse, with current NMC registration.
- Diploma in Nursing 1st Level required or equivalent experience
Experience
Essential
- Ability to use a personal computer, (computer literacy and proficiency in MS Office)
- Post registration experience and successful completion of band 5 foundation gateway competencies.
Desirable
- Study days on research
- Skills in handling and management of computerised data (e.g. the abstraction and coding of medical data, computer data entry, statistical analysis, report generation and data validation)
- Previous experience in clinical research studies, research projects (protocols and study documentation)
- Experience of liaison with staff at all levels in the NHS, Universities and Industry
- An understanding of Research protocols and skills in administration of research and project management Skills in the analysis and interpretation of data
Knowledge
Essential
- An understanding of the role & responsibilities of a Clinical Research Nurse
- An awareness of the principles and practice of clinical research and/or clinical trials
Desirable
- An understanding of ethical and quality standards applicable to clinical trials, including EU Directive on ICH GCP requirements
- An awareness of the Health Service, R&D, the pharmaceutical industry partnership and relevant information sciences
Skills
Essential
- Excellent verbal communication skills
- Ability to prioritise work on own initiative
- Meticulous attention to detail and a high standard of accuracy, e.g. in the capture and validation of clinical trial data
Person Specification
Qualifications
Essential
- Registered Nurse, with current NMC registration.
- Diploma in Nursing 1st Level required or equivalent experience
Experience
Essential
- Ability to use a personal computer, (computer literacy and proficiency in MS Office)
- Post registration experience and successful completion of band 5 foundation gateway competencies.
Desirable
- Study days on research
- Skills in handling and management of computerised data (e.g. the abstraction and coding of medical data, computer data entry, statistical analysis, report generation and data validation)
- Previous experience in clinical research studies, research projects (protocols and study documentation)
- Experience of liaison with staff at all levels in the NHS, Universities and Industry
- An understanding of Research protocols and skills in administration of research and project management Skills in the analysis and interpretation of data
Knowledge
Essential
- An understanding of the role & responsibilities of a Clinical Research Nurse
- An awareness of the principles and practice of clinical research and/or clinical trials
Desirable
- An understanding of ethical and quality standards applicable to clinical trials, including EU Directive on ICH GCP requirements
- An awareness of the Health Service, R&D, the pharmaceutical industry partnership and relevant information sciences
Skills
Essential
- Excellent verbal communication skills
- Ability to prioritise work on own initiative
- Meticulous attention to detail and a high standard of accuracy, e.g. in the capture and validation of clinical trial data
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).