Job summary The post holders main responsibilities will include providing professional, skilled nursing care to ensure safe and efficient running of Cardiovascular research studies. Ideally with experience in TAVI and or cardiac surgery. Responsibility for ensuring research has completed set up with full approval to proceed, screening, recruiting participants, collecting and entering data, responding to data queries and events. The appointee will also identify barriers to recruitment and overcome these. Communicate effectively within the wider MDT together with local R&I, study sponsors and representatives. Provide mentorship and education to other members of the team and assist the Senior Research Nurse. Main duties of the job To develop and maintain constructive working relationship with muti-professional teams within the speciality. Have responsibility for ensuring good communication between all service providers within the speciality. Actively participate in local and national networking groups to develop an expert level of knowledge in the speciality and cascade learning back to the team. Manage a personal caseload of clinical trials and patients independently with minimal supervision. Deliver research activities in a variety of settings; Cardiovascular BRC, outpatient clinics, hospital wards, theatre, cath labs and over the telephone. Support the Lead Investigator in delivering the funded study protocol and supporting the service associated budget. To ensure all work is undertaken in line with the research protocol, ICH-GCP and Research Governance guidelines. To act as one of the primary points of contact for clinical trials patients. To educate other staff as to the responsibilities of the role and function of the research nurse and disseminate information on specific studies. About us Our new strategy, developed with the support and feedback of colleagues, patients, and partners, is our compass for the next seven years (2023-2030). We have four primary goals: high-quality care for all, being a great place to work, partnerships for impact, and research and education excellence And we will embed health equality in all we do - taking active steps to reduce the avoidable differences in healthcare that some people face, working in partnership with communities. Our strategy is underpinned by new values and we will work to ensure they are an everyday reality for all: we are compassionate, we are proud, we are inclusive, and we are one team This is an exciting moment as we look to the future with clarity on what we already do well and where we need to focus our energies to make an even bigger difference for the people we serve. About the University Hospitals of Leicester NHS Trust: http://www.leicestershospitals.nhs.uk/aboutus/work-for-us/current-vacancies/ Job description Job responsibilities The band 6 Research Nurse will manage and co-ordinate specific trials and take responsibility for the trial. They will use their skills and knowledge to achieve this to the highest standard. The post holder will provide the highest standards of patient care in line with research protocols ensuring research safeguards the well-being of the patients and is conducted within ICH Good Clinical Practice guidelines. They will work alongside the Principle Investigators and the research team delivering high quality research using clinical expertise, professional advice, educate the multi-professional team, patients and carers. A personal caseload of clinical trials and patients will be managed independently with minimal supervision. Organisation of any necessary tests and investigations as detailed within the protocol. Sample preparation (e.g. blood, urine, tissue and faecal samples): retrieval, centrifuging, pipetting, slide making and preparation for storage, liaising with the hospital and external laboratories when appropriate. Undertake high risk clinical duties (advanced therapies). Maintaining logs of stored samples and freezer temperatures. Maintaining adequate stock levels of sample kits. Organising the logistical aspects of diagnostic specimens, packaging, and shipment, including handling of dry ice. Organising and completing follow up assessments including toxicity, Quality of Life assessments and telephone assessments. Resolving data queries raised by sponsoring organisations. Archiving all study related material including patients notes after study closure. Reporting and submitting of Serious Adverse Events (SAEs) from this site within stipulated time frames to sponsor organisations and the Research and Innovation Office. Tracking Serious Unexpected Event reporting. Maintaining and updating study specific site files. Notify General Practitioners of their patients involvement in a clinical trial. Observe patients and monitor treatment/toxicity side effects; escalating findings accordingly. To maintain Professional Accountability for nursing research practice at all times.Identifies, screens and recruits patients for the clinical trial using agreed protocols in accordance with ICH-GCP and Research Governance. Provides education and support for patients in research trials. Work with the lead clinician to evaluate clinical trial proposals, identifying potential patient populations and evaluating cost implications of the trial. Participate in set-up/initiation/monitoring visits, site audits and study close-down meetings carried out by sponsoring organisations and regulatory authorities. Responsible for resolving data queries raised by sponsoring organisations. Demonstrates commitment to the role of patient advocate for patients considering or participating in clinical trials. To provide mentorship and supervision for other research professionals and staff within and outside the department. Act as a resource for ward based nurses wishing to undertake research once competencies have been achieved. Responsible for assisting with the completion of study costing templates along with assisting with invoicing and the recovery of income for commercial research as per financial contract agreement. As a new post holder, training will be provided for the key aspects of this role, and a period of induction identified, however, the post holder will be expected to take advantage of opportunities to upgrade their skills and to attend meetings and workshops to enhance their knowledge. Job description Job responsibilities The band 6 Research Nurse will manage and co-ordinate specific trials and take responsibility for the trial. They will use their skills and knowledge to achieve this to the highest standard. The post holder will provide the highest standards of patient care in line with research protocols ensuring research safeguards the well-being of the patients and is conducted within ICH Good Clinical Practice guidelines. They will work alongside the Principle Investigators and the research team delivering high quality research using clinical expertise, professional advice, educate the multi-professional team, patients and carers. A personal caseload of clinical trials and patients will be managed independently with minimal supervision. Organisation of any necessary tests and investigations as detailed within the protocol. Sample preparation (e.g. blood, urine, tissue and faecal samples): retrieval, centrifuging, pipetting, slide making and preparation for storage, liaising with the hospital and external laboratories when appropriate. Undertake high risk clinical duties (advanced therapies). Maintaining logs of stored samples and freezer temperatures. Maintaining adequate stock levels of sample kits. Organising the logistical aspects of diagnostic specimens, packaging, and shipment, including handling of dry ice. Organising and completing follow up assessments including toxicity, Quality of Life assessments and telephone assessments. Resolving data queries raised by sponsoring organisations. Archiving all study related material including patients notes after study closure. Reporting and submitting of Serious Adverse Events (SAEs) from this site within stipulated time frames to sponsor organisations and the Research and Innovation Office. Tracking Serious Unexpected Event reporting. Maintaining and updating study specific site files. Notify General Practitioners of their patients involvement in a clinical trial. Observe patients and monitor treatment/toxicity side effects; escalating findings accordingly. To maintain Professional Accountability for nursing research practice at all times.Identifies, screens and recruits patients for the clinical trial using agreed protocols in accordance with ICH-GCP and Research Governance. Provides education and support for patients in research trials. Work with the lead clinician to evaluate clinical trial proposals, identifying potential patient populations and evaluating cost implications of the trial. Participate in set-up/initiation/monitoring visits, site audits and study close-down meetings carried out by sponsoring organisations and regulatory authorities. Responsible for resolving data queries raised by sponsoring organisations. Demonstrates commitment to the role of patient advocate for patients considering or participating in clinical trials. To provide mentorship and supervision for other research professionals and staff within and outside the department. Act as a resource for ward based nurses wishing to undertake research once competencies have been achieved. Responsible for assisting with the completion of study costing templates along with assisting with invoicing and the recovery of income for commercial research as per financial contract agreement. As a new post holder, training will be provided for the key aspects of this role, and a period of induction identified, however, the post holder will be expected to take advantage of opportunities to upgrade their skills and to attend meetings and workshops to enhance their knowledge. Person Specification Analytical and Judgement skills Essential Ability to interpret and apply study protocols to clinical practice Ability to assess, plan, deliver and evaluate patient care Ability to evaluate patient eligibility for entry into clinical trials against defined protocols Ability to problem solve Able to use initiative Desirable Experience in contributing to ethical reviews or risk assessments Experience Essential Minimum of 2 years post registration clinical experience Experience of clinical trial delivery Cardiovascular experience Desirable Experience of the clinical care of patients enrolled in research studies Experience in coordinating research studies or leading study delivery Experience of TAVI and or Cardiac Surgery Experience in supervising or mentoring junior staff Experience in audit, monitoring, or inspection readiness Training and Qualifications Essential Registered Nurse on appropriate part of the register with current NMC Registration Evidence of on-going professional development Good Clinical Practice (GCP) certification Willing to undertake any necessary training relevant to the post Desirable Postgraduate qualification in research, clinical trials, or related field Research governance or clinical trials management training Communication and relationship skills Essential Excellent verbal and written communication skills Ability to educate and support colleagues, patients and carers Skilled in building effective working relationships across multidisciplinary team Desirable Confidence in liaising with external sponsors and regulatory bodies Skills Essential IT skills (MS Office, NHS systems) Ability to provide clear clinical leadership Competent in clinical procedures relevant to research (e.g., venepuncture, ECGs, sample handling Competent to administer IV, IM, SC and oral medication Ability to work independently and/or as part of a team Proficient in using electronic data capture systems and NHS IT platforms Strong attention to detail and accuracy in documentation Awareness of current national systems and structures for the approval, management and monitoring of clinical research in the NHS Desirable Knowledge of the clinical trial lifecycle, including experience of the set up and performance management of clinical research studies Ability to train others in research procedures Planning and Organisation Essential Ability to manage own clinical case load Ability to manage time effectively, prioritise work and to deliver results consistently to deadlines Demonstrates attention to detail Able to manage multiple studies and competing priorities Proactive in meeting study timelines and regulatory deadlines Desirable Experience in supporting study setup, feasibility, or close-out activities Equality, Diversity and Inclusion Essential Able to demonstrate a commitment and understanding of the importance of treating all individuals with dignity and respect appropriate to their individual needs Awareness of cultural sensitivity in patient engagement and recruitment Desirable Experience in inclusive research practices or public involvement initiatives Commitment to Trust Values and Behaviours Essential Must be able to demonstrate behaviours consistent with the Trust's Values and Behaviours Other requirements specific to the role Essential Highly motivated Flexible approach to working, including ability to work on-call, weekends or evenings where appropriate Desire to develop knowledge Assertive and confident Demonstrates enthusiasm Professional manner Person Specification Analytical and Judgement skills Essential Ability to interpret and apply study protocols to clinical practice Ability to assess, plan, deliver and evaluate patient care Ability to evaluate patient eligibility for entry into clinical trials against defined protocols Ability to problem solve Able to use initiative Desirable Experience in contributing to ethical reviews or risk assessments Experience Essential Minimum of 2 years post registration clinical experience Experience of clinical trial delivery Cardiovascular experience Desirable Experience of the clinical care of patients enrolled in research studies Experience in coordinating research studies or leading study delivery Experience of TAVI and or Cardiac Surgery Experience in supervising or mentoring junior staff Experience in audit, monitoring, or inspection readiness Training and Qualifications Essential Registered Nurse on appropriate part of the register with current NMC Registration Evidence of on-going professional development Good Clinical Practice (GCP) certification Willing to undertake any necessary training relevant to the post Desirable Postgraduate qualification in research, clinical trials, or related field Research governance or clinical trials management training Communication and relationship skills Essential Excellent verbal and written communication skills Ability to educate and support colleagues, patients and carers Skilled in building effective working relationships across multidisciplinary team Desirable Confidence in liaising with external sponsors and regulatory bodies Skills Essential IT skills (MS Office, NHS systems) Ability to provide clear clinical leadership Competent in clinical procedures relevant to research (e.g., venepuncture, ECGs, sample handling Competent to administer IV, IM, SC and oral medication Ability to work independently and/or as part of a team Proficient in using electronic data capture systems and NHS IT platforms Strong attention to detail and accuracy in documentation Awareness of current national systems and structures for the approval, management and monitoring of clinical research in the NHS Desirable Knowledge of the clinical trial lifecycle, including experience of the set up and performance management of clinical research studies Ability to train others in research procedures Planning and Organisation Essential Ability to manage own clinical case load Ability to manage time effectively, prioritise work and to deliver results consistently to deadlines Demonstrates attention to detail Able to manage multiple studies and competing priorities Proactive in meeting study timelines and regulatory deadlines Desirable Experience in supporting study setup, feasibility, or close-out activities Equality, Diversity and Inclusion Essential Able to demonstrate a commitment and understanding of the importance of treating all individuals with dignity and respect appropriate to their individual needs Awareness of cultural sensitivity in patient engagement and recruitment Desirable Experience in inclusive research practices or public involvement initiatives Commitment to Trust Values and Behaviours Essential Must be able to demonstrate behaviours consistent with the Trust's Values and Behaviours Other requirements specific to the role Essential Highly motivated Flexible approach to working, including ability to work on-call, weekends or evenings where appropriate Desire to develop knowledge Assertive and confident Demonstrates enthusiasm Professional manner 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. 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.. UK Registration Applicants must have current UK professional registration. For further information please see 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. 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.. UK Registration Applicants must have current UK professional registration. For further information please see Employer details Employer name University Hospitals of Leicester NHS Trust Address Cardiovascular Biomedical Research Centre GGH Groby Road Leicester LE3 9QP United Kingdom Employer's website