Job summary
We are seeking an enthusiastic, driven, and motivated research nurse to join our Respiratory research team.
Our Respiratory research team is well-established and has a large portfolio of research trials covering Airways disease, Pleural disease, Interstitial lung disease, Lung Cancer and Infection.
In this role you will be responsible for supporting the recruitment and delivery of respiratory research trials alongside other members of the team, as well as completing feasibility assessments for new potential trials and supporting set up of these.
We welcome informal visits and encourage you to contact us for further information.
Main duties of the job
In this role you will be responsible for the feasibility assessment, set up and subsequent co-ordination; recruitment and follow up to both commercial and non-commercial studies, working autonomously and with other members of the team, with a focus on Airways and Pleural research.
About us
North Bristol NHS Trust employs over 12,000 staff providing healthcare to the residents of Bristol, South Gloucestershire and North Somerset from our award-winning hospital building at Southmead. We are the regional Major Trauma Centre, and an internationally recognised centre of excellence in a range of services and major specialties. Our vision is that by enabling our teams to be the best that they can be, we will provide exceptional healthcare, personally delivered.
We commit to treating each patient as an individual with respect and dignity, aiming to deliver excellent clinical outcomes and a first-class experience for everyone who uses our services.
North Bristol NHS Trust values all people as individuals. We aim to be an anti-discriminatory organisation and are committed to building a team that represents a variety of backgrounds, perspectives, and skills. We welcome applicants from all underrepresented groups.
Job description
Job responsibilities
Clinical Trial Set-Up
- Assess trial protocols and advise on safety, regulatory and logistical issues in the running of the trial
- With the PI actively assess the feasibility of studies to be undertaken
- Organise trial feasibility meetings
- Facilitate Site Specific Assessment procedures
- Work with the R&D team in contract negotiations
- Undertake costing of projects to support contract negotiations / grants etc
- Work with the R&D team to ensure all projects have been given full NBT and Research Ethics Committee (REC) approval prior to commencement
- Liaise with NIHR Clinical Research Network personnel in the trial set-up
- Project manage trial set up with colleagues around the trust
Clinical Trial Running
- Support local Principal Investigators in meeting their responsibilities outlined in the Research Governance Framework, Medicines for Human Use (Clinical Trials) Regulations
- Maintain Investigator Site File(s) and complete Case Report File / eCRF with a high degree of accuracy
- Support PIs to ensure all Adverse Events are reported in line with the NBT Adverse Events Reporting policy
- Performs all visits, observations, and interventions with the participants in accordance with the procedures and schedule of the study protocol.
- Ensure appropriate trial information and data is contained in patients hospital notes.
- Ensure Protocol amendments are incorporated into research practice
- Provides and receives complex information in the process of explaining study involvement and obtaining informed consent. Discussion of alternative treatment, benefit and harm
- With the support of appropriate staff, undertakes the management of the research related aspects of care of a group of study participants over the period of the study, which includes:
- The assessment of patients/volunteers for eligibility for research and monitoring their condition throughout their participation.
- Assist in recruitment, follow up and data entry during the period of the trial.
- Acts in the best interests of the research subjects to ensure their rights are upheld.
- Works within the range of research guidelines, ethical principles, and protocols, whilst adhering to organisational policies and procedures.
- Always observes the confidentiality of patient information, in accordance with the Data Protection Act and Caldicott regulations.
- Develops specialist in depth research related knowledge in relation to research governance, International Conference of Harmonisation Good Clinical Practice and the EU clinical trials directive
- Communicates within the project management team and other multidisciplinary staff involved in the project within the hospital, other hospitals, the university, sponsors, NIHR Clinical Research Network and funders.
- Manage the research related aspects of care for participants of multiple research studies.
- Will develop research knowledge and advanced clinical skills including assessment techniques as required to meet the needs of the team.
- Contribute to the writing of Standard Operating Procedures.
Study End
- Enable a smooth transition from the research pathway back to the conventional treatment pathway by ensuring patients are referred to specialist services and / or outpatient clinics.
- Ensure all data clarification issues are resolved quickly
- Manage the archiving of study related documentation in line with the Trial Agreement and ICH-GCP
Job description
Job responsibilities
Clinical Trial Set-Up
- Assess trial protocols and advise on safety, regulatory and logistical issues in the running of the trial
- With the PI actively assess the feasibility of studies to be undertaken
- Organise trial feasibility meetings
- Facilitate Site Specific Assessment procedures
- Work with the R&D team in contract negotiations
- Undertake costing of projects to support contract negotiations / grants etc
- Work with the R&D team to ensure all projects have been given full NBT and Research Ethics Committee (REC) approval prior to commencement
- Liaise with NIHR Clinical Research Network personnel in the trial set-up
- Project manage trial set up with colleagues around the trust
Clinical Trial Running
- Support local Principal Investigators in meeting their responsibilities outlined in the Research Governance Framework, Medicines for Human Use (Clinical Trials) Regulations
- Maintain Investigator Site File(s) and complete Case Report File / eCRF with a high degree of accuracy
- Support PIs to ensure all Adverse Events are reported in line with the NBT Adverse Events Reporting policy
- Performs all visits, observations, and interventions with the participants in accordance with the procedures and schedule of the study protocol.
- Ensure appropriate trial information and data is contained in patients hospital notes.
- Ensure Protocol amendments are incorporated into research practice
- Provides and receives complex information in the process of explaining study involvement and obtaining informed consent. Discussion of alternative treatment, benefit and harm
- With the support of appropriate staff, undertakes the management of the research related aspects of care of a group of study participants over the period of the study, which includes:
- The assessment of patients/volunteers for eligibility for research and monitoring their condition throughout their participation.
- Assist in recruitment, follow up and data entry during the period of the trial.
- Acts in the best interests of the research subjects to ensure their rights are upheld.
- Works within the range of research guidelines, ethical principles, and protocols, whilst adhering to organisational policies and procedures.
- Always observes the confidentiality of patient information, in accordance with the Data Protection Act and Caldicott regulations.
- Develops specialist in depth research related knowledge in relation to research governance, International Conference of Harmonisation Good Clinical Practice and the EU clinical trials directive
- Communicates within the project management team and other multidisciplinary staff involved in the project within the hospital, other hospitals, the university, sponsors, NIHR Clinical Research Network and funders.
- Manage the research related aspects of care for participants of multiple research studies.
- Will develop research knowledge and advanced clinical skills including assessment techniques as required to meet the needs of the team.
- Contribute to the writing of Standard Operating Procedures.
Study End
- Enable a smooth transition from the research pathway back to the conventional treatment pathway by ensuring patients are referred to specialist services and / or outpatient clinics.
- Ensure all data clarification issues are resolved quickly
- Manage the archiving of study related documentation in line with the Trial Agreement and ICH-GCP
Person Specification
Education/Training/Qualifications
Essential
- RGN, with current live Registration
- Significant post registration experience
- Evidence of continuing professional development
Desirable
- Current Good Clinical Practice certification
Work Experience
Essential
- Experience of extended roles e.g. venepuncture, ECG's, link-roles
- Effective personal time and case load management
- Able to work independently and manage day to day work activities
Desirable
- Recent clinical research experience
- Experience in Respiratory nursing
Knowledge/Skills/Abilities
Essential
- Proficient in the use of IT systems with previous experience of using databases and have meticulous data entry skills
- Advanced communication skills, verbal & written, to include report writing and record keeping
- Excellent interpersonal skills with patients and multidisciplinary team.
- Facilitation of development of other staff
- Understanding of the application of research within the clinical environment
- Able to lead projects and work with the wider MDT and external sponsors to coordinate the delivery of this
Desirable
- Awareness of the Trust's Organisational Objectives
Personal Qualities/Special Circumstances
Essential
- Flexible and Punctual
- Excellent attention to detail
- Able to work within a diverse community of patients and healthcare professionals
Person Specification
Education/Training/Qualifications
Essential
- RGN, with current live Registration
- Significant post registration experience
- Evidence of continuing professional development
Desirable
- Current Good Clinical Practice certification
Work Experience
Essential
- Experience of extended roles e.g. venepuncture, ECG's, link-roles
- Effective personal time and case load management
- Able to work independently and manage day to day work activities
Desirable
- Recent clinical research experience
- Experience in Respiratory nursing
Knowledge/Skills/Abilities
Essential
- Proficient in the use of IT systems with previous experience of using databases and have meticulous data entry skills
- Advanced communication skills, verbal & written, to include report writing and record keeping
- Excellent interpersonal skills with patients and multidisciplinary team.
- Facilitation of development of other staff
- Understanding of the application of research within the clinical environment
- Able to lead projects and work with the wider MDT and external sponsors to coordinate the delivery of this
Desirable
- Awareness of the Trust's Organisational Objectives
Personal Qualities/Special Circumstances
Essential
- Flexible and Punctual
- Excellent attention to detail
- Able to work within a diverse community of patients and healthcare professionals
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).
