Job summary
We would like to make you aware of the recent government announcement that from 1 April 2022 (subject to parliamentary approval), everyone working in the NHS (including Sheffield Children's NHS Foundation Trust) in roles that have face-to-face contact with patients and service users, will need to provide evidence that they have been fully vaccinated against COVID-19, unless they are medically exempt. Details on the announcement can be found via the following link: https://www.gov.uk/government/consultations/making-vaccination-a-condition-of-deployment-in-the-health-and-wider-social-care-sector
Based on this announcement, you should consider your personal position when applying for jobs at the Trust which may be affected by this change.
Information about COVID-19 vaccines is available at: www.gov.uk/government/collections/immunisation and www.nhs.uk/conditions/coronavirus-covid-19/coronavirus-vaccination/coronavirus-vaccine
For women of childbearing age, please read the detailed guidance at: www.nhs.uk/covidvaccination
The post holder will be responsible for supporting the coordination of recruitment to and monitoring of clinical trials across all paediatric/adult specialties at the Trust.
Main duties of the job
-
- Be responsible for the coordination and running of complex clinical trials including clinical trials of an investigational medicinal products (CTIMP) both commercial and non-commercial and other types of clinical research in the Trust.
- Will maintain investigator site files, study documentation accurately and comprehensively.
- Carry out procedures in line with research protocol with full compliance to the Research Governance Framework/EU Clinical Trials Directive and Good Clinical Practice.
- Be involved with the process of recruitment, information giving and consent procedures for the involvement of patients / parents / carers / healthy volunteers in research.
- Work with the investigators and other research personnel to ensure smooth running of research projects from set up to close out.
- Plan, implement and evaluate care for an allocated patient group, in consideration of individual need, using prioritisation and delegation skills.
- Act as an advocate for patients / carers and volunteers participating in research.
- Participate in the continued development of the clinical research facility team and the Trust's researchers, including the supervision, teaching and development of junior staff.
- Assist the Clinical Research Lead in managing and developing the Clinical Research Facility systems and standard operating procedures.
- Be involved in the Directorates audit programme and assist with clinical trial monitoring visits and inspections.
About us
The post will be based within the Clinical Genetics Department which is located at Outpatient 2 at Northern General Hospital but occasionally you may be expected to work in clinics elsewhere in the city or work across the other sites in Sheffield which together form Sheffield Children's NHS Foundation Trust. There will also be a requirement to attend research meetings both locally and nationally.
Sheffield Children's is one of three independent, specialist paediatric hospitals in the country, providing dedicated healthcare for children and young people across community, mental health and acute specialist settings.
We have three overarching aims that set the direction for the Trust in our vision "to create a healthier future for children and young people."
- Outstanding patient care
- Brilliant place to work
- Leader in children's health
Our commitment to rewarding colleagues is demonstrated through our brilliant reward and benefits offer including; generous annual leave entitlement and pension scheme and access to salary sacrifice schemes such as cycle to work and lease cars.
We are committed to supporting colleagues from different heritages and lifestyles while at work. This is supported through the offer we have in place for flexible working and the three equality network groups we have in place. Colleagues are encouraged to join these groups and request flexible working.
Job description
Job responsibilities
Communication and relationship skills
- To always maintain confidentiality of information regarding patients.
- Ability to provide complex research related information to research participants and their families when taking consent for the research study or carrying out a research procedure.
- Ensure that verbal and written information provided to research participants is appropriate.
- To communicate and liaise effectively with all members of the multidisciplinary and research teams within and external to the Trust, both verbally and in writing, providing and receiving complex or sensitive information.
- Ensure parents/carers and the child (when appropriate), have the opportunity to agree and/or negotiate care in line with research protocols.
- Provide training to researchers and research colleagues as required
Knowledge, training, and experience
Registered nurse or midwife
- Knowledge of local, national, and international research regulations and guidance.
- To understand and undertake training in Good Clinical Practice (GCP).
- To co-ordinate and facilitate research projects and clinical trials within the Trust.
- To undertake administration of prescribed medication within the Trust policy for administration of medicines.
- To be aware of the resources available for continuing education and demonstrate a positive attitude towards self-development.
- To work within Trust Child Safeguarding Policies and undertake safeguarding training at Level 3.
- Identify own personal and professional needs through the personal development review process, knowledge, and skills framework & clinical supervision process and to work and achieve objectives set.
- To ensure that personal mandatory and statutory training requirements are met in accordance with Sheffield Childrens NHS Foundation Trust policies, maintaining own professional profile.
- Maintain competence in the use of medical devices used in research activity in the Trust.
Analytical and judgement skills
- Ability to analyse complex facts and situations where decisions need to be made about the inclusion or exclusion of a participant on a trial and where this needs to be reconciled with the study protocol.
- Ability to assess patient condition, clinical situations and report as necessary adverse events and serious adverse events and breaches of GCP and the trial protocol.
- Utilise clinical and risk assessment skills to maintain a safe working environment.
- To review current practice and report to ward/departmental manager areas requiring change.
- Liaise with supporting departments to facilitate appointments for research participants to attend for research visits and assessments / interventions.
- Be able to manage and prioritise own workload and tasks, working to appropriate deadlines and to any targets set.
- Manage and co-ordinate the smooth running of allocated research projects, providing support as required to other research nurses within the Clinical Research Facility, elsewhere in the Trust and in local our research networks.
- To utilise various IT systems and platforms in place to transmit research data, communicate with external organisations and manage workload
- Ensure appropriate facilities and resources are available as required per research visit.
Providing patient/client care
- To be responsible for research participants care and wellbeing during their time participating on a study or trial.
- Ensure protocols are strictly followed and provide highly specialised advice concerning care during the trial and to guarantee that the study investigator is notified of any deviations from the protocol.
- Ensure that Adverse Events, Serious Adverse Events and Suspected Unexpected Serious Adverse Reactions are reported appropriately, and that patient safety is the priority and maintained at all times during study participation.
- Facilitate the consent and recruitment process in conjunction with local investigators.
- To be aware of the psychological/emotional needs of the patient/carer, responding and reporting appropriately.
- All staff have a responsibility to report all clinical and non-clinical accidents or incidents promptly and, when requested, to co-operate with any investigation undertaken.
- Recognise and report / manage any complaints from patients / carers, with support from Modern Matron, PALS or Risk Management Dept.
Supporting Service Development
- Works with strict adherence to the research governance framework, EU Clinical Trials Directive, and all other local, national and international mandated research policies.
- Promote clinical excellence through participating in setting, maintaining and monitoring standards of care within the clinical governance framework and take part in audit and benchmarking.
- To participate and assist in systematic monitoring and evaluation of nursing practice within the department and keep abreast of new developments in nursing and research practice.
- holder will work under clearly defined occupational, research and specific
Mental effort
- Frequent concentration where work pattern can be unpredictable
- Frequent prolonged concentration for meticulously accurate data collection and preparing research documentation
- To be alert to changing needs of patients, research participants and staff.
Emotional effort
- Post holder may occasionally come across distressing circumstances
- Requirement to explain complex clinical trials to patients and carers
- Providing ongoing support for research participants and their carers
Working conditions
- Occasional unpleasant working conditions - potential for distressed patients / carers.
- To have daily direct exposure to blood and body fluids.
- To work with pharmaceutical products under COSHH regulations.
- Recognise areas of potential conflict responding effectively to verbal or physical aggression using conflict resolution skills,
- Though post is based in the Northern General OPD2, occasionally there may be a requirement to work at another of the Trusts sites in Sheffield or to conduct home visits.
- Though the standard daily working pattern will be 9 to 5 there may be the occasional requirement to work out of hours / weekends to accommodate clinical trial protocols.
- Must be willing and able to attend relevant meetings / conferences / investigator meetings for clinical trials which can take place in the UK or overseas.
Inclusive Recruitment & Selection
We offer encouragement and active support to applicants with additional needs, including those from ethnic minorities, with disabilities and members of the LGBTQ+ community. If you wish to adjust any aspect of the recruitment process or wish to find out more about our recruitment & selection processes, please get in touch with our Recruitment Manager: Catherine.Gilbert7@nhs.net
We are currently reviewing our recruitment & selection process and are looking to make our job adverts more inclusive. This will support the long-term aim of Sheffield Childrens being a champion of Equality, Diversity and Inclusion. If you have any ideas in how we can make our recruitment & selection process more inclusive, please get in touch with Catherine Gilbert at Catherine.Gilbert7@nhs.net
Trust Values
The Trust is committed to providing great quality patient care and keep children, young people and families at the heart of what we do by following our CARE values:
- Compassion leading by kindness and showing empathy, understanding and respect
- Accountability striving to do the right thing and owning responsibility
- Respect value differences, tackling inequality and fostering a culture of inclusion
- Excellence delivering a high-quality standard of care
Job description
Job responsibilities
Communication and relationship skills
- To always maintain confidentiality of information regarding patients.
- Ability to provide complex research related information to research participants and their families when taking consent for the research study or carrying out a research procedure.
- Ensure that verbal and written information provided to research participants is appropriate.
- To communicate and liaise effectively with all members of the multidisciplinary and research teams within and external to the Trust, both verbally and in writing, providing and receiving complex or sensitive information.
- Ensure parents/carers and the child (when appropriate), have the opportunity to agree and/or negotiate care in line with research protocols.
- Provide training to researchers and research colleagues as required
Knowledge, training, and experience
Registered nurse or midwife
- Knowledge of local, national, and international research regulations and guidance.
- To understand and undertake training in Good Clinical Practice (GCP).
- To co-ordinate and facilitate research projects and clinical trials within the Trust.
- To undertake administration of prescribed medication within the Trust policy for administration of medicines.
- To be aware of the resources available for continuing education and demonstrate a positive attitude towards self-development.
- To work within Trust Child Safeguarding Policies and undertake safeguarding training at Level 3.
- Identify own personal and professional needs through the personal development review process, knowledge, and skills framework & clinical supervision process and to work and achieve objectives set.
- To ensure that personal mandatory and statutory training requirements are met in accordance with Sheffield Childrens NHS Foundation Trust policies, maintaining own professional profile.
- Maintain competence in the use of medical devices used in research activity in the Trust.
Analytical and judgement skills
- Ability to analyse complex facts and situations where decisions need to be made about the inclusion or exclusion of a participant on a trial and where this needs to be reconciled with the study protocol.
- Ability to assess patient condition, clinical situations and report as necessary adverse events and serious adverse events and breaches of GCP and the trial protocol.
- Utilise clinical and risk assessment skills to maintain a safe working environment.
- To review current practice and report to ward/departmental manager areas requiring change.
- Liaise with supporting departments to facilitate appointments for research participants to attend for research visits and assessments / interventions.
- Be able to manage and prioritise own workload and tasks, working to appropriate deadlines and to any targets set.
- Manage and co-ordinate the smooth running of allocated research projects, providing support as required to other research nurses within the Clinical Research Facility, elsewhere in the Trust and in local our research networks.
- To utilise various IT systems and platforms in place to transmit research data, communicate with external organisations and manage workload
- Ensure appropriate facilities and resources are available as required per research visit.
Providing patient/client care
- To be responsible for research participants care and wellbeing during their time participating on a study or trial.
- Ensure protocols are strictly followed and provide highly specialised advice concerning care during the trial and to guarantee that the study investigator is notified of any deviations from the protocol.
- Ensure that Adverse Events, Serious Adverse Events and Suspected Unexpected Serious Adverse Reactions are reported appropriately, and that patient safety is the priority and maintained at all times during study participation.
- Facilitate the consent and recruitment process in conjunction with local investigators.
- To be aware of the psychological/emotional needs of the patient/carer, responding and reporting appropriately.
- All staff have a responsibility to report all clinical and non-clinical accidents or incidents promptly and, when requested, to co-operate with any investigation undertaken.
- Recognise and report / manage any complaints from patients / carers, with support from Modern Matron, PALS or Risk Management Dept.
Supporting Service Development
- Works with strict adherence to the research governance framework, EU Clinical Trials Directive, and all other local, national and international mandated research policies.
- Promote clinical excellence through participating in setting, maintaining and monitoring standards of care within the clinical governance framework and take part in audit and benchmarking.
- To participate and assist in systematic monitoring and evaluation of nursing practice within the department and keep abreast of new developments in nursing and research practice.
- holder will work under clearly defined occupational, research and specific
Mental effort
- Frequent concentration where work pattern can be unpredictable
- Frequent prolonged concentration for meticulously accurate data collection and preparing research documentation
- To be alert to changing needs of patients, research participants and staff.
Emotional effort
- Post holder may occasionally come across distressing circumstances
- Requirement to explain complex clinical trials to patients and carers
- Providing ongoing support for research participants and their carers
Working conditions
- Occasional unpleasant working conditions - potential for distressed patients / carers.
- To have daily direct exposure to blood and body fluids.
- To work with pharmaceutical products under COSHH regulations.
- Recognise areas of potential conflict responding effectively to verbal or physical aggression using conflict resolution skills,
- Though post is based in the Northern General OPD2, occasionally there may be a requirement to work at another of the Trusts sites in Sheffield or to conduct home visits.
- Though the standard daily working pattern will be 9 to 5 there may be the occasional requirement to work out of hours / weekends to accommodate clinical trial protocols.
- Must be willing and able to attend relevant meetings / conferences / investigator meetings for clinical trials which can take place in the UK or overseas.
Inclusive Recruitment & Selection
We offer encouragement and active support to applicants with additional needs, including those from ethnic minorities, with disabilities and members of the LGBTQ+ community. If you wish to adjust any aspect of the recruitment process or wish to find out more about our recruitment & selection processes, please get in touch with our Recruitment Manager: Catherine.Gilbert7@nhs.net
We are currently reviewing our recruitment & selection process and are looking to make our job adverts more inclusive. This will support the long-term aim of Sheffield Childrens being a champion of Equality, Diversity and Inclusion. If you have any ideas in how we can make our recruitment & selection process more inclusive, please get in touch with Catherine Gilbert at Catherine.Gilbert7@nhs.net
Trust Values
The Trust is committed to providing great quality patient care and keep children, young people and families at the heart of what we do by following our CARE values:
- Compassion leading by kindness and showing empathy, understanding and respect
- Accountability striving to do the right thing and owning responsibility
- Respect value differences, tackling inequality and fostering a culture of inclusion
- Excellence delivering a high-quality standard of care
Person Specification
Qualifications
Essential
- Degree or Diploma as Registered Nurse or Midwife
Desirable
- Clinical Skills: Venepuncture and Cannulation
Experience
Essential
- Significant work experience - at least 3 years post registration experience for registered staff
- Significant knowledge/experience of delivering clinical research studies
Desirable
- Eperince of co-ordinating and delivering multi centred clinical studies and complex interventional trials
Knowledge and Skills
Essential
- Knowledge of EU Directive for Clinical Trials
Person Specification
Qualifications
Essential
- Degree or Diploma as Registered Nurse or Midwife
Desirable
- Clinical Skills: Venepuncture and Cannulation
Experience
Essential
- Significant work experience - at least 3 years post registration experience for registered staff
- Significant knowledge/experience of delivering clinical research studies
Desirable
- Eperince of co-ordinating and delivering multi centred clinical studies and complex interventional trials
Knowledge and Skills
Essential
- Knowledge of EU Directive for Clinical Trials
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
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).
