Job summary
Would you like to take the next step in your nursing career and support the delivery of world class health research to improve peoples lives? An exciting opportunity has arisen within the National Institute of Health Research Clinical Research Network (NIHR CRN), for two Band 6 research Nurses to join the CRN Eastern team, based at Howard House Surgery, Felixstowe.
As part of the team you would be working in a range of non-hospital settings (e.g. primary care, community services, care homes, schools) to support and champion health and social care research.
Developmental opportunities will be considered to initially commence as a Band 5, and with the support training to develop into a Band 6.
Secondment opportunities will be considered.
Main duties of the job
The role is people focused involving recruiting participants into a wide range of research studies, receiving informed consent, conducting study procedures and the collection of baseline and follow up data in accordance with ICH GCP. The role can also involve office based work at times. You will be required to travel across the locality and wider throughout the Eastern region.
You must be a Registered Nurse or Practitioner (with valid NMC / HCPC registration) and possess excellent organisational, communication and interpersonal skills. Previous experience as a research Nurse is highly desirable, but not essential as training can be provided, however a wide range of clinical experience is important. In addition, we offer a comprehensive training programme and on-going support, actively encouraging continuing professional development.
About us
East Suffolk and North Essex NHS Foundation Trust (ESNEFT) provide hospital and community health services to people living across a wide geographical area. We deliver care from two main hospitals in Colchester and Ipswich, six community hospitals and in patients own homes. You will be joining a team of 10,000 amazing colleagues providing care to 800,000 residents.
Our philosophy is that time matters to everyone. Too often, our current systems and ways of working add unnecessary stress and frustration. Across the Trust, we concentrate on improving the things we do and removing those which do not work or cause time delays for our staff and patients throughout our day-to-day business.
If you are passionate about patient care and want to develop your skills and knowledge then we are keen to hear from you
Job description
Job responsibilities
Purpose of Role:
- The post-holder will assist in developing, supporting and promoting involvement in health & social care research for the National Institute of Health Research Clinical Research Network Eastern (CRN Eastern)
- Working closely with a multidisciplinary team, the key responsibilities are: to help identify eligible study/clinical trial participants; recruitment and informed consent; provision of information and support for patients/participants; co-ordination of study/trial patient treatment, assessment, follow up and data collection, in accordance with ICH Good Clinical Practice, Research Governance and EU Clinical Trials legislation
- The research nurse will be a member of the CRN Eastern team in Suffolk and North East Essex (Clinical Commissioning Group areas) and will primarily support clinical studies on the NIHR portfolio taking place in non-hospital settings, e.g. primary and community care, care homes, schools.
- The post holder will work collaboratively with teams across a range of non-hospital sites and with key individuals. From time to time shifts may be available in other primary care locality areas.
- The post holder is a recognised expert in one or more specialities and in the field of clinical research. He/she will take responsibility for the co-ordination and management of health & social care research projects, collaborating with key personnel throughout the network in primary, secondary care and non-NHS setting to ensure continued care and support for participants involved in research. From time to time the post holder may be required to work across other locality areas, depending on services.
- The post will require some flexible working in order to meet the requirements of recruitment and the research protocol and possibly some unsocial hours. The post holder will be required to visit research participants in their own homes, care homes, schools and also service clinics. This post requires the ability to travel routinely within the East of England and to travel outside the region, as required, for the role.
Key duties and Responsibilities:
Clinical
- Screen & identify participants eligible for research studies and to maintain detailed knowledge of the protocols for the studies associated with the designated site-specific groups.
- Assess protocols and advise on safety, regularity and logistical issues for the set-up and running of the study/trial to ensure the well-being and safety of patients, participants and staff
- Provide participants with specialist information regarding their participation, including risk factors
- Provide a high standard and continuity of care for participants for the duration of the research study, maintaining lines of communication with clinical/social care staff
- Act as resource to participants, their families and staff from within the clinical area, providing information and support; and to act as an effective referral to other support agencies where necessary
- Work within dedicated CRN Eastern team; ensure ethical and clinical safe practice
- Undertake research-associated laboratory work safely, as required
- Work at all times as part of the extended multidisciplinary team and maintain excellent links with staff regarding the protocol care required for study/clinical trial participants
- Retrieve and retain medical records of participants for trial duration
- Achieve and maintain defined competencies for clinical research to ensure that capability, skill and knowledge are appropriate for the work undertaken
- Undertake, with appropriate training, interventional treatments directly to participants according to the study/trial protocol and procedures and record the resulting information
- Take and process clinical samples (e.g. venepuncture/cannulation) for studies, co-ordinate tissue sample collection and dispatch to relevant department or trial centre as appropriate
- Maintain clinical skills as appropriate e.g. phlebotomy, vital sign assessment, patient compliance and ECGs
Research
- Conduct research according to standards and regulations laid down in ICH Good Clinical Practice and EU Directives, and to the most current guidelines relating to the Health Research Authority (HRA)
- Assist in the provision of background information about potential clinical trials, working with R&D teams to ensure the sites capability and capacity assessments are undertaken
- Co-ordinate and manage research within expected timelines
- Work within and contribute towards the development and review of Standard Operating Procedures (SOPs) and local policies/procedures for clinical research
- Understand the requirements of the study protocol and adhere to them
- Identify suitable participants eligible for the study/clinical trial, in conjunction with the site investigator; identify, screen and recruit research participants using detailed knowledge of the protocols for the designated site specific groups
- Prepare patient/participant documentation for treatment clinics with meticulous attention to detail and complete accurate records of patient care, maintaining source data and CRFs in a clearly traceable system, to ensure data validity
- Report Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) immediately using the appropriate procedures
- Provide ongoing support, advice and information to patients/participants with regard to their participation in clinical research in order to facilitate an effective informed consent process
- Receive informed consent where appropriate; maintain the continuous informed consent of participants to ensure that the procedures and treatments agreed within the trial protocol are
- Co-ordinate own case load of participants within the allocated trials, e.g. organising trial-specific investigations, study treatments, appointments etc. as necessary
- Meet with trial sponsors as necessary, providing information requested on trial participants
- Participate in research protocol design, development and review: ensure that ethical issues are addressed and all personnel involved in the study/trial are made aware of any changes or protocol amendments
- Advise when necessary on high quality participant information sheets
- Collect accurate local data and deliver to clinical trial centres in a timely manner adhering at all times to the terms of the Data Protection Act
- Record own observations and those of other healthcare professionals, in the trial database, with accuracy
- Help to maintain the core entry database; participate in CRF completion, safety reporting, protocol compliance, monitoring and auditing of clinical trials
- Attend relevant local, regional and national meetings related to specific trials
- Assist with the resolution of data queries; contribute to financial processes of planning, running and closedown of studies
- Contribute to study closure and archival preparation
- Contribute to nurse-led research
- Take opportunities to publish and present findings of research undertaken
- Assist with the dissemination of research finding
Please see attached job description for full details.
Job description
Job responsibilities
Purpose of Role:
- The post-holder will assist in developing, supporting and promoting involvement in health & social care research for the National Institute of Health Research Clinical Research Network Eastern (CRN Eastern)
- Working closely with a multidisciplinary team, the key responsibilities are: to help identify eligible study/clinical trial participants; recruitment and informed consent; provision of information and support for patients/participants; co-ordination of study/trial patient treatment, assessment, follow up and data collection, in accordance with ICH Good Clinical Practice, Research Governance and EU Clinical Trials legislation
- The research nurse will be a member of the CRN Eastern team in Suffolk and North East Essex (Clinical Commissioning Group areas) and will primarily support clinical studies on the NIHR portfolio taking place in non-hospital settings, e.g. primary and community care, care homes, schools.
- The post holder will work collaboratively with teams across a range of non-hospital sites and with key individuals. From time to time shifts may be available in other primary care locality areas.
- The post holder is a recognised expert in one or more specialities and in the field of clinical research. He/she will take responsibility for the co-ordination and management of health & social care research projects, collaborating with key personnel throughout the network in primary, secondary care and non-NHS setting to ensure continued care and support for participants involved in research. From time to time the post holder may be required to work across other locality areas, depending on services.
- The post will require some flexible working in order to meet the requirements of recruitment and the research protocol and possibly some unsocial hours. The post holder will be required to visit research participants in their own homes, care homes, schools and also service clinics. This post requires the ability to travel routinely within the East of England and to travel outside the region, as required, for the role.
Key duties and Responsibilities:
Clinical
- Screen & identify participants eligible for research studies and to maintain detailed knowledge of the protocols for the studies associated with the designated site-specific groups.
- Assess protocols and advise on safety, regularity and logistical issues for the set-up and running of the study/trial to ensure the well-being and safety of patients, participants and staff
- Provide participants with specialist information regarding their participation, including risk factors
- Provide a high standard and continuity of care for participants for the duration of the research study, maintaining lines of communication with clinical/social care staff
- Act as resource to participants, their families and staff from within the clinical area, providing information and support; and to act as an effective referral to other support agencies where necessary
- Work within dedicated CRN Eastern team; ensure ethical and clinical safe practice
- Undertake research-associated laboratory work safely, as required
- Work at all times as part of the extended multidisciplinary team and maintain excellent links with staff regarding the protocol care required for study/clinical trial participants
- Retrieve and retain medical records of participants for trial duration
- Achieve and maintain defined competencies for clinical research to ensure that capability, skill and knowledge are appropriate for the work undertaken
- Undertake, with appropriate training, interventional treatments directly to participants according to the study/trial protocol and procedures and record the resulting information
- Take and process clinical samples (e.g. venepuncture/cannulation) for studies, co-ordinate tissue sample collection and dispatch to relevant department or trial centre as appropriate
- Maintain clinical skills as appropriate e.g. phlebotomy, vital sign assessment, patient compliance and ECGs
Research
- Conduct research according to standards and regulations laid down in ICH Good Clinical Practice and EU Directives, and to the most current guidelines relating to the Health Research Authority (HRA)
- Assist in the provision of background information about potential clinical trials, working with R&D teams to ensure the sites capability and capacity assessments are undertaken
- Co-ordinate and manage research within expected timelines
- Work within and contribute towards the development and review of Standard Operating Procedures (SOPs) and local policies/procedures for clinical research
- Understand the requirements of the study protocol and adhere to them
- Identify suitable participants eligible for the study/clinical trial, in conjunction with the site investigator; identify, screen and recruit research participants using detailed knowledge of the protocols for the designated site specific groups
- Prepare patient/participant documentation for treatment clinics with meticulous attention to detail and complete accurate records of patient care, maintaining source data and CRFs in a clearly traceable system, to ensure data validity
- Report Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) immediately using the appropriate procedures
- Provide ongoing support, advice and information to patients/participants with regard to their participation in clinical research in order to facilitate an effective informed consent process
- Receive informed consent where appropriate; maintain the continuous informed consent of participants to ensure that the procedures and treatments agreed within the trial protocol are
- Co-ordinate own case load of participants within the allocated trials, e.g. organising trial-specific investigations, study treatments, appointments etc. as necessary
- Meet with trial sponsors as necessary, providing information requested on trial participants
- Participate in research protocol design, development and review: ensure that ethical issues are addressed and all personnel involved in the study/trial are made aware of any changes or protocol amendments
- Advise when necessary on high quality participant information sheets
- Collect accurate local data and deliver to clinical trial centres in a timely manner adhering at all times to the terms of the Data Protection Act
- Record own observations and those of other healthcare professionals, in the trial database, with accuracy
- Help to maintain the core entry database; participate in CRF completion, safety reporting, protocol compliance, monitoring and auditing of clinical trials
- Attend relevant local, regional and national meetings related to specific trials
- Assist with the resolution of data queries; contribute to financial processes of planning, running and closedown of studies
- Contribute to study closure and archival preparation
- Contribute to nurse-led research
- Take opportunities to publish and present findings of research undertaken
- Assist with the dissemination of research finding
Please see attached job description for full details.
Person Specification
Qualifications
Essential
- RGN Adult with current NMC registration
Desirable
- Has basic knowledge of recent NHS legislation and policy
Experience
Essential
- 4 years' experience, with a minimum of 2 years' experience at Band 5
- At least 2 years' experience working in a Primary Care or community care setting
- Project management experience
- Working with patient/service users
- Experience of collaborating with other agencies
Desirable
- Experience of running concurrent research studies with minimal supervision according to Good Clinical Practice guidelines
Knowledge and Skills
Essential
- Knowledge of clinical research infrastructure in the UK
- Understand the structure, role & functions of the HRA and the R+D departments
- Understanding of the requirements of ICH Good Clinical Practice
- Knowledge of the role of the clinical research nurse; understanding the issues/process of gaining informed consent
- Excellent interpersonal and communication skills - Both written and verbal
Desirable
- Working knowledge of clinical trials relevant to PCRN
- Evidence of continuing professional development
- Possess current ICH GCP Certificate
- Knowledge of one or more general database systems
Person Specification
Qualifications
Essential
- RGN Adult with current NMC registration
Desirable
- Has basic knowledge of recent NHS legislation and policy
Experience
Essential
- 4 years' experience, with a minimum of 2 years' experience at Band 5
- At least 2 years' experience working in a Primary Care or community care setting
- Project management experience
- Working with patient/service users
- Experience of collaborating with other agencies
Desirable
- Experience of running concurrent research studies with minimal supervision according to Good Clinical Practice guidelines
Knowledge and Skills
Essential
- Knowledge of clinical research infrastructure in the UK
- Understand the structure, role & functions of the HRA and the R+D departments
- Understanding of the requirements of ICH Good Clinical Practice
- Knowledge of the role of the clinical research nurse; understanding the issues/process of gaining informed consent
- Excellent interpersonal and communication skills - Both written and verbal
Desirable
- Working knowledge of clinical trials relevant to PCRN
- Evidence of continuing professional development
- Possess current ICH GCP Certificate
- Knowledge of one or more general database systems
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).
