Job summary
The Research Nurse will manage and support clinical research trials across both the Paediatric CF Centre based at the Royal London Children's Hospital and the Adult CF Centre based at St Bartholomew's Hospital. You will work closely with members of the local CF clinical and research teams including other London Network centre Trial Coordinators, the Head of the CTAP at the Cystic Fibrosis Trust and Trial Coordinators at other Trial Accelerator centres around the UK.
Previous research experience is desirable for the post but CF experience is not essential as a comprehensive training and development programme will be available to the successful candidate.
For more information, please contact
Dr Caroline Pao, Paediatric CF Centre Director: carolinepao@nhs.net
Dr Danie Watson, Adult CF Centre Director: danie.watson@nhs.net
Nicolene Plaatjies (Senior Research Nurse): nicolene.plaatjies@nhs.net or on 02035941551
Main duties of the job
Barts Health NHS Trust run a portfolio of national and multicentre randomised controlled trials, and targeted treatments in the area of Cystic Fibrosis. We collaborate closely with other CF CTAP sites across London. To reflect our on-going expansion of our trials portfolio, we require a Research Nurse to assist with the day-to-day management of Trial Accelerator supported clinical trials.
The Research Nurse will work closely with members of the local CF clinical and research teams, including other Trial Coordinators particularly from the other London Network centres, the Head of the CTAP at the Cystic Fibrosis Trust and Trial Coordinators at other Trial Accelerator centres. .
Key responsibilities of the post will include overseeing the efficient set up and delivery of Cystic Fibrosis clinical trials, ensuring timely accrual and high-quality data collection.
About us
Barts Health is one of the largest NHS trusts in the country, and one of Britain's leading healthcare providers.
The Barts Health group of NHS hospitals is entering an exciting new era on our improvement journey to becoming an outstanding organisation with a world-class clinical reputation. Having lifted ourselves out of special measures, we now have the impetus and breathing space to chart a fresh course in which we are continually striving to improve all our services for patients.
Our vision is to be a high-performing group of NHS hospitals, renowned for excellence and innovation, and providing safe and compassionate care to our patients in east London and beyond. That means being a provider of excellent patient safety, known for delivering consistently high standards of harm-free care and always caring for patients in the right place at the right time. It also means being an outstanding place to work, in which our WeCare values and behaviours are visible to all and guide us in how we work together.
We strive to live by our WeCare values and are committed to promoting inclusion, where every staff member has a sense of belonging. We value our differences and fully advocate, cultivate and support an inclusive working environment.
Job description
Job responsibilities
Key responsibilities of the post include overseeing the efficient set up (initiation) and delivery (management) of CF clinical trials, ensuring timely accrual and high-quality data collection and will involve contact with patients/families and carrying out clinical care for patients in studies. The responsibilities of the post-holder include:
Trial Initiation
- Liaising with industry partners and the Cystic Fibrosis Trust to ensure speedy set up and delivery of studies.
- Completion of IRAS forms for ethical, regulatory and HRA approvals.
- Ensure the required approvals and agreements are in place at the lead site and associated patient identification centres (PICs) before the trial opens to recruitment.
- Attend site initiation visits.
- Act as the principal point of contact for participating sites, sponsor(s), funder(s), pharmaceutical partners, regulatory authorities and the oversight committees.
- Organise and attend meetings of the oversight committees, preparing the agenda and meeting papers, and taking minutes as required
Clinical Research
- Oversee the day-to-day conduct of trials at your centre and any patient identification centres, providing support and advice and addressing any logistical issues as they arise.
- Identify potential participants (adults and children) for research studies in cystic fibrosis, working with identified Patient Identification Centres (PICs) as appropriate.
- Work with respiratory research leads and other key members of staff to recruit participants and collect meaningful scientific data for these studies, and coordinating and delivering clinical trials across adults and paediatrics.
- Obtain and document informed consent (as permitted by sponsors).
- Review medical notes and collect auditable research data in an accurate and timely manner.
- Administer study drugs and perform clinical assessments including collection and processing of blood and other samples, with full documentation
- Where necessary, support monitoring visits at your site to verify trial activities are compliant with trial protocols, GCP and all applicable regulations.
- Ensure trial recruitment and retention are monitored and establish procedures for dealing with any recruitment and retention problems in collaboration with the Head of the Trials Accelerator.
- Update trial documentation as necessary e.g. protocols, trial guidance notes, case report forms (CRFs) and patient information sheets.
- Promptly report Adverse Events to a senior member of the research team according to study protocols.
- Maintain quality control procedures for all aspects of trial conduct to ensure compliance with the principles of Good Clinical Practice, research governance standards and all applicable legislation (e.g. The Medicines for Human Use (Clinical Trials) Regulations, Data Protection Act, Good Clinical Laboratory Practice, Human Tissue Act /Human Tissue Bill (Scotland)).
- Maintain the Investigator Site File to ensure a clear audit trail of trial activities is retained.
- Facilitate any audit, inspection or progress visit processes required by regulatory bodies, or sponsor(s).
- Costing and contract of studies.
- Ensure collaborator sites are compensated appropriately for patients successfully recruited to a clinical trial at the lead centre.
- Update Patient finance log and liaise closely with finance R&D.
- Archiving and trial close out
Patient/Participant care
The post holders primary concern will be to maintain patient safety during the conduct of clinical trials. The post holder will be responsible for:
- Screening of case notes for appropriate candidates for the relevant studies and discussing with patients about the opportunity to join a relevant study.
- Facilitating the research study process including scheduling patient visits and undertaking the relevant patient assessment, investigations and treatment in accordance with the studies protocol.
- Being a point of contact for study participants, giving advice on the relevant study and correlated health issues.
- Ensure that participants expenses are processed promptly.
- Facilitate studies via patient recruitment either in outpatients, on the wards or telephoning patients to arrange appointments. This may involve gathering clinical data and conducting some measures of health status, examples include:
- Questionnaire administration
- Obtaining blood samples using phlebotomy skills
- Performance of physiologic tests such as Spirometry or Electrocardiog
Teamwork and communication
- Attend Trial Accelerator meetings and training events as and when required.
- Become an active member of the CF centres multi-disciplinary team, ensuring all colleagues are kept well informed and up to date of research related activities.
- Writing and circulating summaries of meetings as requested.
- Promoting CF Clinical Trials at scientific meetings and to prospective patients.
- Having an active email account which is monitored regularly with information shares appropriately.
- Develop and review SOPs for the CTAP London Network to improve processes of conducting studies and collaboration across Londons CF Centres.
- Liaise closely with the Head of the Trial Accelerator at the Cystic Fibrosis Trust to ensure on-going clinical, scientific and operational oversight.
- Demonstrate a courteous and helpful approach to patients, relatives and visitors in the clinical area within their own capabilities; promoting the corporate image of the Trust to all individuals, groups and organisations, both within the Trust and externally to the community at large
Research promotion
- Liaise with participating centres and potential collaborators to promote trial recruitment.
- Draft and circulate regular newsletters.
- Plan, organise and give presentations at meetings of investigators/research nurses/trial coordinators as appropriate.
- Promote the trials and CTAP at national scientific meetings developing presentation materials (slides/posters/flyers) as required.
- Act as a point of contact for the local CF community to discuss clinical trial opportunities. Identify methods to raise awareness of CF research within your centres CF population.
- With senior staff, prepare funding applications for new study proposals.
We are dedicated to being an outstanding place to work and will work with you to get the best experience. We know flexible working is not a one size fits all and will mean something different to everyone. We are inclusive, so if you are interested in flexible working, please speak to the recruiting manager.
Job description
Job responsibilities
Key responsibilities of the post include overseeing the efficient set up (initiation) and delivery (management) of CF clinical trials, ensuring timely accrual and high-quality data collection and will involve contact with patients/families and carrying out clinical care for patients in studies. The responsibilities of the post-holder include:
Trial Initiation
- Liaising with industry partners and the Cystic Fibrosis Trust to ensure speedy set up and delivery of studies.
- Completion of IRAS forms for ethical, regulatory and HRA approvals.
- Ensure the required approvals and agreements are in place at the lead site and associated patient identification centres (PICs) before the trial opens to recruitment.
- Attend site initiation visits.
- Act as the principal point of contact for participating sites, sponsor(s), funder(s), pharmaceutical partners, regulatory authorities and the oversight committees.
- Organise and attend meetings of the oversight committees, preparing the agenda and meeting papers, and taking minutes as required
Clinical Research
- Oversee the day-to-day conduct of trials at your centre and any patient identification centres, providing support and advice and addressing any logistical issues as they arise.
- Identify potential participants (adults and children) for research studies in cystic fibrosis, working with identified Patient Identification Centres (PICs) as appropriate.
- Work with respiratory research leads and other key members of staff to recruit participants and collect meaningful scientific data for these studies, and coordinating and delivering clinical trials across adults and paediatrics.
- Obtain and document informed consent (as permitted by sponsors).
- Review medical notes and collect auditable research data in an accurate and timely manner.
- Administer study drugs and perform clinical assessments including collection and processing of blood and other samples, with full documentation
- Where necessary, support monitoring visits at your site to verify trial activities are compliant with trial protocols, GCP and all applicable regulations.
- Ensure trial recruitment and retention are monitored and establish procedures for dealing with any recruitment and retention problems in collaboration with the Head of the Trials Accelerator.
- Update trial documentation as necessary e.g. protocols, trial guidance notes, case report forms (CRFs) and patient information sheets.
- Promptly report Adverse Events to a senior member of the research team according to study protocols.
- Maintain quality control procedures for all aspects of trial conduct to ensure compliance with the principles of Good Clinical Practice, research governance standards and all applicable legislation (e.g. The Medicines for Human Use (Clinical Trials) Regulations, Data Protection Act, Good Clinical Laboratory Practice, Human Tissue Act /Human Tissue Bill (Scotland)).
- Maintain the Investigator Site File to ensure a clear audit trail of trial activities is retained.
- Facilitate any audit, inspection or progress visit processes required by regulatory bodies, or sponsor(s).
- Costing and contract of studies.
- Ensure collaborator sites are compensated appropriately for patients successfully recruited to a clinical trial at the lead centre.
- Update Patient finance log and liaise closely with finance R&D.
- Archiving and trial close out
Patient/Participant care
The post holders primary concern will be to maintain patient safety during the conduct of clinical trials. The post holder will be responsible for:
- Screening of case notes for appropriate candidates for the relevant studies and discussing with patients about the opportunity to join a relevant study.
- Facilitating the research study process including scheduling patient visits and undertaking the relevant patient assessment, investigations and treatment in accordance with the studies protocol.
- Being a point of contact for study participants, giving advice on the relevant study and correlated health issues.
- Ensure that participants expenses are processed promptly.
- Facilitate studies via patient recruitment either in outpatients, on the wards or telephoning patients to arrange appointments. This may involve gathering clinical data and conducting some measures of health status, examples include:
- Questionnaire administration
- Obtaining blood samples using phlebotomy skills
- Performance of physiologic tests such as Spirometry or Electrocardiog
Teamwork and communication
- Attend Trial Accelerator meetings and training events as and when required.
- Become an active member of the CF centres multi-disciplinary team, ensuring all colleagues are kept well informed and up to date of research related activities.
- Writing and circulating summaries of meetings as requested.
- Promoting CF Clinical Trials at scientific meetings and to prospective patients.
- Having an active email account which is monitored regularly with information shares appropriately.
- Develop and review SOPs for the CTAP London Network to improve processes of conducting studies and collaboration across Londons CF Centres.
- Liaise closely with the Head of the Trial Accelerator at the Cystic Fibrosis Trust to ensure on-going clinical, scientific and operational oversight.
- Demonstrate a courteous and helpful approach to patients, relatives and visitors in the clinical area within their own capabilities; promoting the corporate image of the Trust to all individuals, groups and organisations, both within the Trust and externally to the community at large
Research promotion
- Liaise with participating centres and potential collaborators to promote trial recruitment.
- Draft and circulate regular newsletters.
- Plan, organise and give presentations at meetings of investigators/research nurses/trial coordinators as appropriate.
- Promote the trials and CTAP at national scientific meetings developing presentation materials (slides/posters/flyers) as required.
- Act as a point of contact for the local CF community to discuss clinical trial opportunities. Identify methods to raise awareness of CF research within your centres CF population.
- With senior staff, prepare funding applications for new study proposals.
We are dedicated to being an outstanding place to work and will work with you to get the best experience. We know flexible working is not a one size fits all and will mean something different to everyone. We are inclusive, so if you are interested in flexible working, please speak to the recruiting manager.
Person Specification
Qualifications
Essential
- Registered NMC Adult Nurse
Desirable
- Registered NMC Children Nurse
Experience
Essential
- Minimum of 3 years post nursing registration clinical experience
- Experience of working on multiple parallel tasks to strict and often tight deadlines.
- Experience of managing information systems and developing databases and spread sheets
- Experience of coordinating and managing patient care
- Previous experience of change management and problem solving
- Previous experience & understanding of research and audit methodologies
- Experience in teaching and training to be able to deliver training
Desirable
- Experience of analysing large quantities of complex information from databases and generating reports
- Experience or recruiting, educating, sample collecting and monitoring patients within clinical trial
- Experience in leadership and organisational skills to be able to coordinate different research studies and supervise or managing multi-disciplinary team
Knowledge
Essential
- Understanding and/or knowledge of research governance and regulations (ICH/GCP and EU Directives)
- Understanding and/or knowledge of research governance and regulations (ICH/GCP and EU Directives)
- Understanding and/or knowledge of research governance and regulations (ICH/GCP and EU Directives)
- Understanding of safeguarding issues
- Awareness of equality and diversity
- Knowledge of the Data Protection Act
Desirable
- Previous Clinical Trial experience
- Knowledge of current national systems and structures for the approval, management and monitoring of clinical research in the NHS
- Knowledge of medical terminology / Cystic Fibrosis
- Leadership and management development
Skills
Essential
- Numerate with advanced IT skills to be able to compile, interrogate and analyse data to produce meaningful and accessible management reports and make appropriate recommendations (MS Office 2003 and above - Access, Excel and PowerPoint).
- Effective teaching, training skills
- Able to problem solve and initiate change
- Able to work across professional team and organisational boundaries
- Proven time management skills a to be able to work calmly under pressure and manage and prioritise own and others workloads whilst performing to tight deadlines
- Ability to work as part of team and autonomously
Desirable
- Effective managerial, leadership and organisational skills to be able to make sound judgements, use own initiative and work with minimal day-to-day supervision.
- Phlebotomy and cannulation skills
- Handling and transporting biological specimens
Other
Essential
- Excellent verbal and written communication and listening skills with the ability to interact effectively with staff at all levels
- Able to handle sensitive and/or confidential information
- Up to date with mandatory and statutory training
Desirable
- Attending appropriate study days and conferences
Person Specification
Qualifications
Essential
- Registered NMC Adult Nurse
Desirable
- Registered NMC Children Nurse
Experience
Essential
- Minimum of 3 years post nursing registration clinical experience
- Experience of working on multiple parallel tasks to strict and often tight deadlines.
- Experience of managing information systems and developing databases and spread sheets
- Experience of coordinating and managing patient care
- Previous experience of change management and problem solving
- Previous experience & understanding of research and audit methodologies
- Experience in teaching and training to be able to deliver training
Desirable
- Experience of analysing large quantities of complex information from databases and generating reports
- Experience or recruiting, educating, sample collecting and monitoring patients within clinical trial
- Experience in leadership and organisational skills to be able to coordinate different research studies and supervise or managing multi-disciplinary team
Knowledge
Essential
- Understanding and/or knowledge of research governance and regulations (ICH/GCP and EU Directives)
- Understanding and/or knowledge of research governance and regulations (ICH/GCP and EU Directives)
- Understanding and/or knowledge of research governance and regulations (ICH/GCP and EU Directives)
- Understanding of safeguarding issues
- Awareness of equality and diversity
- Knowledge of the Data Protection Act
Desirable
- Previous Clinical Trial experience
- Knowledge of current national systems and structures for the approval, management and monitoring of clinical research in the NHS
- Knowledge of medical terminology / Cystic Fibrosis
- Leadership and management development
Skills
Essential
- Numerate with advanced IT skills to be able to compile, interrogate and analyse data to produce meaningful and accessible management reports and make appropriate recommendations (MS Office 2003 and above - Access, Excel and PowerPoint).
- Effective teaching, training skills
- Able to problem solve and initiate change
- Able to work across professional team and organisational boundaries
- Proven time management skills a to be able to work calmly under pressure and manage and prioritise own and others workloads whilst performing to tight deadlines
- Ability to work as part of team and autonomously
Desirable
- Effective managerial, leadership and organisational skills to be able to make sound judgements, use own initiative and work with minimal day-to-day supervision.
- Phlebotomy and cannulation skills
- Handling and transporting biological specimens
Other
Essential
- Excellent verbal and written communication and listening skills with the ability to interact effectively with staff at all levels
- Able to handle sensitive and/or confidential information
- Up to date with mandatory and statutory training
Desirable
- Attending appropriate study days and conferences
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).
