Detailed job description and main 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 patient's 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 patient's 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 criteria 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 criteria Experience in contributing to ethical reviews or risk assessments Experience Essential criteria Minimum of 2 years post registration clinical experience Experience of clinical trial delivery Cardiovascular experience Desirable criteria 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 criteria 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 criteria Postgraduate qualification in research, clinical trials, or related field Research governance or clinical trials management training Communication and relationship skills Essential criteria 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 criteria Confidence in liaising with external sponsors and regulatory bodies Skills Essential criteria 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 criteria 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 criteria 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 criteria Experience in supporting study setup, feasibility, or close-out activities Equality, Diversity and Inclusion Essential criteria 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 criteria Experience in inclusive research practices or public involvement initiatives Commitment to Trust Values and Behaviours Essential criteria Must be able to demonstrate behaviours consistent with the Trust's Values and Behaviours Other requirements specific to the role Essential criteria 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 Additional Information Please submit your application form without delay to avoid disappointment; we will close vacancies prior to the publishing closing date if we receive a sufficient number of completed application forms. Please check the email account (including your junk mail) that you supplied as part of your application on a regular basis following the closing date and throughout the recruitment process, as this is how we will communicate with you. UHL is an equal opportunities employer. We aim to employ a workforce that reflects the diverse communities we serve. We welcome applications from people from all backgrounds who match our job criteria. Applicants who have a disability and meet the essential criteria for the job will be interviewed if you indicate you wish to be considered under the Guaranteed Interview Scheme. If you require a reasonable adjustment at any stage of the recruitment process please make the recruitment services team aware as soon as possible. UHL is committed to helping colleagues balance the demands of both their work and personal needs through flexible working arrangements wherever reasonably practicable and subject to service needs. Disclosure and Barring Service Check Please note if you are successful in obtaining this position and the post involves regulated activity you will be required to undertake a Disclosure & Barring Service check. The Trust will pay for the check initially and the money will then be deducted from your salary over a three month period commencing on your first month's payment. The current price of a check is £38 for an enhanced and £18 for a standard check. COVID 19 Risk Assessment Due to the current Covid pandemic we have introduced a staff risk assessment into our pre-employment process. This now forms part of the mandatory pre-employment checks that will be carried out if you receive a conditional offer. The risk assessment is intended to ensure you are able to safely perform your duties in any of our work areas, and if you have been identified as being particularly vulnerable to coronavirus. Our main aim is to reduce risk and to ensure the safety of all new starters to the Trust as well as current staff, patients and visitors. If it is identified that you are within a vulnerable category, we will endeavor to make reasonable adjustments to accommodate this through discussions with both Occupational Health and your recruiting manager. Covid Vaccination Status Covid-19 vaccination remains the best way to protect yourself, family, colleagues and our patients/service users from the Covid-19 virus. We therefore continue to encourage our current and potential colleagues to get vaccinated. University Hospitals of Leicester NHS Trust holds the principles of equality, diversity and inclusion at the heart of everything it does and all that it stands for. We are committed to developing a workforce that is representative of the community we serve. We welcome applications from the diverse community of Leicester, Leicester and Rutland, to help deliver healthcare services that meets the needs of our diverse communities. Employer certification / accreditation badges