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Job Description Job Description JOB TITLE: Clinical Research Nurse Manager DIRECTORATE: Research & Innovation / Corporate GRADE: AfC band 8A REPORTS TO: Deputy Director, Research & Innovation ACCOUNTABLE TO: Director, Research & Innovation JOB SUMMARY Nottingham University Hospitals (NUH) NHS Trust has identified excellence in research for the benefit of patients as a core component of its corporate vision to be the best acute teaching organisation by 2016. In order to realise this vision, the Trust has formed a close research partnership with the University of Nottingham (UoN), with a common research strategy and an integrated system of research management and governance. This research partnership has recently been awarded three prestigious National Centres of Excellence; the Arthritis Research UK Pain Centre that has been created to investigate the mechanisms that lead to the chronic pain experienced by sufferers of arthritis and to improve the treatment of that pain and two National Institute of Health Research (NIHR) Biomedical Research Units which are in Deafness and Hearing Problems and Gastrointestinal (including liver disease). NUH also hosts a Respiratory Disease biomedical research centre. The partnership has also been outstandingly successful in other major NIHR competitions. NUH, in close collaboration with the Nottingham Clinical Trials Unit is also the host of a multitude of NIHR programme grants, including groundbreaking research in the areas of Evidence- based Dermatology and Age and Ageing. NUH also hosts and works in close partnership with the Trent Comprehensive Clinical Research Network. The primary focus of the CRM and the nurse bank will be the development of the portfolio and the successful delivery of commercial clinical trials. NUH is committed to the development of dynamic partnerships with the Life Sciences Industry and the expansion of the commercial research portfolio in order to maximise patient access to innovative treatments. In undertaking this role, all employees will be expected to behave at all times in a way that is consistent with and actively supports the principles listed in the Consultation Document on the creation of the Nottingham University Hospitals NHS Trust. These are: The principles of the NHS, where high quality care is provided on the basis of need rather than the ability to pay. The contribution of the local community to the development of our services. Preserving and developing our reputation as a caring organisation. Developing services that are designed around the patient. Working co-operatively with others in the interests of patients and their families.

Valuing the contribution of staff and investing in their development. Valuing the diversity of all our staff, patients and carers and demonstrating a zero tolerance of discrimination. The importance of developing innovative approaches to teaching, research and service provision,which allows us to be at the forefront of developments in patient care. VALUES AND BEHAVIOURS: NUH has a set of values and behaviours to improve the experience for our patients and our staff (We are here for you). This means that in undertaking this role the post holder is expected at all times to behave is a way that demonstrates commitment to the delivery of thoughtful patient care and continuous improvement as detailed in the table below. Thoughtful Patient Care Caring and helpful Polite, respect individuals, thoughtful, welcoming Helpful, kind, supportive, don t wait to be asked Listening, informing, communicating Safe and vigilant Clean hands and hospital so patients are safe Professional, ensure patients feel safe Honest, will speak up if needed to stay safe Clinically excellent Best outcomes through evidence-led clinical care Compassionate, gentle, see whole person Value patients time to minimise waiting Continuous Improvement Accountable and reliable Reliable and happy to be measured Appreciative of the contribution of others Effective and supportive team-working Best use of time & resources Simplify processes, to find more time to care Eliminate waste, investing for patients Making best use of every pound we spend Innovation for patients Empowerment to act on patient feedback Improvement led by research and evidence Teaching the next generation KEY JOB RESPONSIBILITIES The post will be the professional nursing lead for the clinical research nurses working on clinical trials across the Trust. This includes responsibility for the following: Close working practices with the Deputy Director of R&I and clinicians in all directorates in the Trust planning new clinical trials to ensure efficient delivery of high quality research. Planning yearly clinical activity to match any capacity limitations. To act as a clinical research nurse for designated studies within the Trust s Portfolio Co-ordinate the clinical research nurse bank. Monitor and raise the standards of nursing/therapy input within this team. Liaison with colleague senior research nurses to enhance performance and development of research nurses/therapists. Ensuring all research activity adheres to study protocols and is delivered on time and target through excellent communication with patients, medical personnel, research managers and investigators.

Clinical Responsibilities and Duties The post-holder will be required to supervise, and when the need arises perform the following clinical trial management duties: To maintain accurate, complete and timely data and records in accordance with the study protocol To maintain own caseload of studies using organisational skills and showing the ability to meet deadlines To have flexibility in approach taking into account clinical and patient needs for studies To plan and organise daily study tasks including the organising and smooth running of clinics and referral to other health professionals according to study protocol. To carry responsibility for the conduct of clinical trials across multiple patient groups, ensuring study protocols and best clinical practice are adhered to. To be the contact for study patients during work hours and to ensure patients know how to obtain advice outside work hours To communicate effectively with patients and carers, research study personnel, internal and external departments To ensure adherence to protocol, accurate data and ethical practice To provide advice and support for study patients and their carers To ensure a seamless transition for patients between study and continuing care To provide specialist clinical technical services according to the study protocol requirements that may include such skills as Phlebotomy, ECGs, Functional Measurements, and Immediate Life Support To ensure collection of information, relating to patients medical conditions and analyses to provide an appropriate response. To regularly undertake Risk Assessments to ensure a safe environment is maintained To undertake research projects in different disease areas as necessary. This will include cover for colleagues e.g. if absent and will be dependant on the NUH current portfolio of industry sponsored trials. Management Responsibilities and Duties Review and lead the development and implementation of new Clinical Research studies undertaken within the NUH commercial research portfolio To assess and evaluate the progress of on-going clinical trials and research undertaken in the NUH commercial research portfolio. Maintaining an accurate account of the status of the projects and to regularly update the Industry lead on the status. To safeguard interest of patients by liaison with relevant trial personnel and contribution to trial design and protocol and ensure compliance with ICH GCP Guidelines. To drive and encourage the participation in original research carried out in the Trust. Liaison with pharmaceutical sponsors regarding feasibility and implementation aspects of proposed clinical trials. Liaison with the multidisciplinary team to promote and oversee the appropriate referral and recruitment of patients to research within the Trust. To ensure that all proposed research projects carried out in the research team are registered and reviewed by the Trust R & I department and Research Ethics Committee (REC) prior to commencement and that updates and amendments are reported in a timely fashion. To ensure that all ICH GCP required documentation is kept in a clearly trackable system and is stored appropriately. To establish and maintain good internal and external working relationships with supporting clinical services in order to promote an active research ethos at all times.

To monitor and plan in advance, workload of the department ensuring it is adequately resourced, liaising with the Deputy Director as appropriate. In conjunction with directorate leads and the Deputy Director of R&I, develop and update a strategy for commercial research within the Trust Work with R&I research managers regarding costings of potential research projects including feasibility, contract and liaison with sponsors. Professional Responsibilities To work as part of the NUH R&I team and contribute to the ongoing development of the NUH Research Strategy To provide ongoing advice and information to patients/volunteers with regard to their participation in clinical research in order to facilitate effective informed consent. To assist the clinicians in the assessment of patients/volunteers for eligibility for research and monitoring of their condition throughout their participation. To be responsible for maintaining strong relationships and positive communication channels with other key personnel and commercial sponsors Work within the NMC Code Of Conduct and scope of professional practice To observe the confidentiality of patient information at all times, both in accordance with the Data Protection Act. Staff Management and Development To act as a leader, resource and role model To take responsibility for the supervision and management of the research nurses/therapists in the NUH clinical research nurse bank. To be responsible for ensuring all members of the clinical research nurse bank team undergo regular and effective appraisal, and to support appropriate training and development opportunities in line with role requirements. To be responsible for ensuring the on-going recruitment of staff when necessary, and ensure that job descriptions and staff contracts are reviewed on a regular basis in conjunction with other senior staff. To be responsible for the co-ordination of annual leave and all other leave for the clinical research nurse bank ensuring minimal disruption to the service provided to the Trust. To facilitate and maintain effective communication within the nurse bank. This list of responsibilities is not exhaustive, the post holder will be expected to undertake any other relevant duties appropriate to the grading of the post. GENERAL DUTIES In addition to the key job responsibilities detailed in this job description all employees at Nottingham University Hospitals NHS Trust are expected to comply with the general duties detailed below: Infection Control To maintain a clean, safe environment, ensuring adherence to the Trust s standards of cleanliness, hygiene and infection control.

For senior/clinical managers the following statement must also be included The post holder is accountable for minimising the risks of infections and for the implementation of the Code of Practice for the Prevention and Control of Healthcare Associated Infections as outlined in the Health Act 2006. This includes receiving assurance of risk and embedding evidence based practice into daily routines of all staff. Safeguarding children, young people and vulnerable adults Nottingham University Hospitals is committed to safeguarding and promoting the welfare of children, young people and vulnerable adults. All staff and volunteers are therefore expected to behave in such a way that supports this commitment. Information Governance All staff have an individual responsibility for creating accurate records of their work and for making entries into and managing all NHS records effectively in line with the Health Record Keeping Policy and other Health Records and Corporate Records Management policies and procedures in order to meet the Trust s legal, regulatory and accountability requirements. Health and Safety To take reasonable care to prevent injury to themselves or others who may be affected by their acts or omissions. To co-operate fully in discharging the Trust policies and procedures with regard to health and safety matters. To immediately report to their manager any shortcomings in health and safety procedures and practice. To report any accidents or dangerous incidents to their immediate manager and safety representative as early as possible and submit a completed accident/incident form. To use protective clothing and equipment where provided. Whilst the aim of the Trust is to promote a co-operative and constructive view of health and safety concerns in the organisation, all staff must be aware that a wilful or irresponsible disregard for safety matters may give rise to disciplinary proceedings. Governance To actively participate in governance activities to ensure that the highest standards of care and business conduct are achieved. General Policies Procedures and Practices To comply with all Trust policies, procedures and practices and to be responsible for keeping up to date with any changes to these.

WORKING CONDITIONS Describe the post holder s normal working conditions (such as exposures to hazards, requirement for physical effort etc). This is an office based role requiring normal office hours to be worked. There will be travel to other offices and meetings, all expenses will be paid. JOB REVISION This job description should be regarded as a guide to the duties required and is not definitive or restrictive in any way. The duties of the post may be varied from time to time in response to changing circumstances. This job description does not form part of the contract of employment. Service Review A strategic review of all Trust services is taking place, as a result of which some services, or parts of some services, may transfer from one campus to the other. This will be decided in accordance with the most appropriate way to provide the best healthcare for patients in the future and all staff will be fully consulted on about the impact of any such decisions. The Nottingham NHS Treatment Centre The new Nottingham NHS Treatment Centre opened on the QMC campus in late July 2008. The Nottingham NHS Treatment Centre is run and managed by Nations Healthcare - an Independent Sector Provider. A range of outpatient, day case and diagnostic services are transferring into the Treatment Centre from Nottingham University Hospitals NHS Trust in a phased way over a period of several months. As a result of this, the work that you do may be affected in one of several ways: 1. Your work may not be affected at all. 2. You may be required to undertake work on behalf of the Treatment Centre. 3. You may be required to undertake some of your existing work in the Treatment Centre. 4. You may be seconded to work in the Treatment Centre. Staff seconded to do all or some of their work in the Treatment Centre will remain the employees of Nottingham University Hospitals Trust and throughout the period of their secondment. Job description reviewed Date June 2012