Job summary Do you have a passion for improving patient care and treatment pathways? Then come and join our established and dynamic research team where you will spend your time as an essential part of our team. Research is an integral part of healthcare and Clinical research nurses and AHPs play a vital role in delivering clinical research, and ultimately improving patient care and treatment pathways. An opportunity has arisen within the Research and Development Department for a Clinical Research Nurse or AHP to support the Multispecialty Research Team. This is a Band 5 post, initially fixed for 12 months, with the potential for extension dependent upon continued funding. We will consider a secondment for this position. Main duties of the job We are looking for a highly motivated team player who is interested in supporting research delivery. Ideally you will have Ophthalmology experience or experience working in a clinical research environment and knowledge of the research process in the NHS. Excellent IT skills are also a requirement for this role. The post holder will be involved in the day-to-day running of clinical trials which involves recruitment, treatment, monitoring, and collection of blood for pharmacokinetic / pharmacodynamics studies, and the provision of support to the patients involved. You will also be expected to liaise with study sponsors and other research partners. About us This post offers the opportunity to develop your clinical and research skills, and to be part of a growing research community. Full research training and continuing professional development is considered a high priority within the team and will be provided from induction onwards. Delivering relevant, important clinical research for our patients is all part of a day's work in our friendly Research and Development Team at the James Paget University Hospital NHS Foundation Trust. Date posted 01 November 2024 Pay scheme Agenda for change Band Band 5 Salary £29,970 to £36,483 a year per annum, pro rata Contract Fixed term Duration 1 years Working pattern Part-time Reference number 177-CORP-6632689 Job locations James Paget University Hospital Lowestoft Road Great Yarmouth NR31 6LA Job description Job responsibilities Main duties and Responsibilities Key research areas: For observational research studies: Work autonomously within operating procedures and study protocols to manage his/her caseload of patients, whilst working as part of a multi-disciplinary team. Interview, recruit, receive informed consent and support patients and carers in observational trials/studies. This involves educating patients on the trials involved, explaining the advantages and disadvantages of taking part in observational studies/trials, whilst remaining unbiased at all times. Assess patients as required by trial protocols relating to inclusion and exclusion criteria and study related tasks. Enhanced clinical skills: ability to take blood samples, vital sign measurement (including temperature, blood pressure, pulse and respiratory rate) and know how to act upon significant results. Pregnancy testing. Maintain high quality patient records and ensure all relevant information is documented in the patients notes and relevant research case report and other forms are completed to Good Clinical Practice (GCP) standards. Provide continuity of care for patients and their carers throughout the trial programme. Provide non-clinical advice and support as appropriate to patients and carers. Ensure the provision of optimal patient care by alerting appropriate clinical colleagues when referral to other members of the MDT may be required. For both observational and interventional research trials/studies. Attend MDT meetings and liaise with MDT members to establish procedures for the safe and smooth running of clinical trials and act as a resource and contact point in matters concerning trial patients and trial protocols. Screen for and identify suitable patients for trials by assessing patients against criteria defined by all trial protocols. Arrange and where appropriate perform, investigations required to establish eligibility and safety for trial/study entry. Review patient records, identify source data, accurately collect and complete a range of complex and more simplistic data collection forms both electronically and in paper format, in timeframes required by both the study Sponsor and GCP. Administer questionnaires/diaries to patients, provide instruction and subsequent collection. Perform consistency checks on data collected for each patient throughout their trial journey. Resolve inconsistencies and respond to data collection queries. Responsible for identifying safety reporting (either from communicating with patients/relatives, carers or clinical colleagues, or from investigating medical records) and reporting these within both GCP and individual study deadlines. Design forms to capture source data; the forms will be specific to each trial but will have an agreed format. Design and maintain spreadsheets/databases to track patient journeys in trials/studies. The spreadsheets/databases may be used by all members of the research team as an information and/or planning resource. Responsible for ensuring trial/study participants adhere to trial protocols, for example, clinic appointments within correct windows (including the pre-planning of visit dates and booking of appointments). Provide support to the lead study nurse for interventional studies for clinical and non-clinical tasks. Ensure that trials/studies are conducted according to the Research Governance Framework, EU Clinical Trials Directive EU2001/20EC and EU GCP Directive 2005/28/EC. Maintain clinical trial site files to ensure a complete audit trail for trials. Be part of the departmental research team in the review of trial/study protocols and identify resource implications for the site. Assist with trial set-up, liaising with clinicians, supporting departments, other healthcare professionals and trials units, as required. To act as a direct contact for clinical trial/study patients. To help identify barriers to recruitment and performance, communicating these to the study team and Senior Clinical Research Nurse. Job description Job responsibilities Main duties and Responsibilities Key research areas: For observational research studies: Work autonomously within operating procedures and study protocols to manage his/her caseload of patients, whilst working as part of a multi-disciplinary team. Interview, recruit, receive informed consent and support patients and carers in observational trials/studies. This involves educating patients on the trials involved, explaining the advantages and disadvantages of taking part in observational studies/trials, whilst remaining unbiased at all times. Assess patients as required by trial protocols relating to inclusion and exclusion criteria and study related tasks. Enhanced clinical skills: ability to take blood samples, vital sign measurement (including temperature, blood pressure, pulse and respiratory rate) and know how to act upon significant results. Pregnancy testing. Maintain high quality patient records and ensure all relevant information is documented in the patients notes and relevant research case report and other forms are completed to Good Clinical Practice (GCP) standards. Provide continuity of care for patients and their carers throughout the trial programme. Provide non-clinical advice and support as appropriate to patients and carers. Ensure the provision of optimal patient care by alerting appropriate clinical colleagues when referral to other members of the MDT may be required. For both observational and interventional research trials/studies. Attend MDT meetings and liaise with MDT members to establish procedures for the safe and smooth running of clinical trials and act as a resource and contact point in matters concerning trial patients and trial protocols. Screen for and identify suitable patients for trials by assessing patients against criteria defined by all trial protocols. Arrange and where appropriate perform, investigations required to establish eligibility and safety for trial/study entry. Review patient records, identify source data, accurately collect and complete a range of complex and more simplistic data collection forms both electronically and in paper format, in timeframes required by both the study Sponsor and GCP. Administer questionnaires/diaries to patients, provide instruction and subsequent collection. Perform consistency checks on data collected for each patient throughout their trial journey. Resolve inconsistencies and respond to data collection queries. Responsible for identifying safety reporting (either from communicating with patients/relatives, carers or clinical colleagues, or from investigating medical records) and reporting these within both GCP and individual study deadlines. Design forms to capture source data; the forms will be specific to each trial but will have an agreed format. Design and maintain spreadsheets/databases to track patient journeys in trials/studies. The spreadsheets/databases may be used by all members of the research team as an information and/or planning resource. Responsible for ensuring trial/study participants adhere to trial protocols, for example, clinic appointments within correct windows (including the pre-planning of visit dates and booking of appointments). Provide support to the lead study nurse for interventional studies for clinical and non-clinical tasks. Ensure that trials/studies are conducted according to the Research Governance Framework, EU Clinical Trials Directive EU2001/20EC and EU GCP Directive 2005/28/EC. Maintain clinical trial site files to ensure a complete audit trail for trials. Be part of the departmental research team in the review of trial/study protocols and identify resource implications for the site. Assist with trial set-up, liaising with clinicians, supporting departments, other healthcare professionals and trials units, as required. To act as a direct contact for clinical trial/study patients. To help identify barriers to recruitment and performance, communicating these to the study team and Senior Clinical Research Nurse. Person Specification Qualifications Essential Registered Nurse/AHP Evidence of recent short courses and/or study days on research Desirable GCP Certificate Degree in health-sciences or willingness to work towards Skills Essential Ability to take blood and perform vital signs (Blood pressure, temperature, pulse, respiratory rate), pregnancy testing and blood glucose measurements Excellent IT skills (Microsoft Office inc word, excel, powerpoint, Diary management etc) Able to prioritise workload and meet deadlines within a challenging environment Flexible and responsive to change Problem solving skills Desirable Ability to be able to lead on an observational-only research study Analysis of study data Experience Essential Recent experience working in a busy NHS clinical or research environment Experience of dealing with difficult situations and coming to resolutions Desirable Experience working in Ophthalmology Understanding of research pathway from idea to delivery and close-out Knowledge of ethical and quality standards applicable to clinical trials Communication and relationship skills Essential Able to communicate concerns in a timely manner Effective oral and written communication skills Ability to handle sensitive situations and challenging attitudes Demonstrable experience of communicating with patients/carers Desirable Demonstrable experience of communicating with Research Study Sponsors or external companies Person Specification Qualifications Essential Registered Nurse/AHP Evidence of recent short courses and/or study days on research Desirable GCP Certificate Degree in health-sciences or willingness to work towards Skills Essential Ability to take blood and perform vital signs (Blood pressure, temperature, pulse, respiratory rate), pregnancy testing and blood glucose measurements Excellent IT skills (Microsoft Office inc word, excel, powerpoint, Diary management etc) Able to prioritise workload and meet deadlines within a challenging environment Flexible and responsive to change Problem solving skills Desirable Ability to be able to lead on an observational-only research study Analysis of study data Experience Essential Recent experience working in a busy NHS clinical or research environment Experience of dealing with difficult situations and coming to resolutions Desirable Experience working in Ophthalmology Understanding of research pathway from idea to delivery and close-out Knowledge of ethical and quality standards applicable to clinical trials Communication and relationship skills Essential Able to communicate concerns in a timely manner Effective oral and written communication skills Ability to handle sensitive situations and challenging attitudes Demonstrable experience of communicating with patients/carers Desirable Demonstrable experience of communicating with Research Study Sponsors or external companies 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 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). Employer details Employer name James Paget University Hospitals NHS Foundation Trust Address James Paget University Hospital Lowestoft Road Great Yarmouth NR31 6LA Employer's website https://www.jpaget.nhs.uk/work-for-us/ (Opens in a new tab)