Faculty of Medicine and Health School of Medicine Leeds Institute of Clinical Trials Research Clinical Co-ordinator Part-time – 20% of full time basis This post is available for a fixed term of 6 months Please note, this post is open to staff in the Leeds Institute of Clinical Trials Research only A Clinical Co-ordinator is required to take up this exciting opportunity to take a lead role in the delivery of a portfolio of pressure ulcer and wound research; and to provide clinical expertise while co-ordinating trial implementation across 40 community and acute NHS organisations. You will work closely with Professor Jane Nixon (Chief Investigator), and other co-applicants including senior academic and NHS colleagues, clinical nurse specialists, Leeds based Research Fellows, the LICTR team and RM&G and Finance Departments. The post holder will contribute to the development of strategic direction and strategy development of the LICTR Comprehensive Research Division and Skin Portfolio from an NHS perspective. You will also develop strategic partnerships with NHS organisations, including commissioners, to translate the research outputs across acute and primary care. We are seeking a Registered Level 1 Nurse who is educated to degree level in nursing (or other health related subject) with solid experience in tissue viability and evidence of leading and facilitating Trust wide evidence based nursing practice in the NHS using clinical audit (or similar) methodology. You will have effective organisational skills demonstrated by proven ability to prioritise work and successfully manage and complete projects; as well as strong negotiation and facilitation skills. Applicants must have a current, valid driving licence with the ability to travel to research centres, as required. The University of Leeds is committed to providing equal opportunities for all and offers a range of family friendly policies (http://hr.leeds.ac.uk/homepage/4/policies). The University is a charter member of Athena SWAN and holds the Bronze award. The School of Medicine gained the Bronze award in 2013. We are committed to being an inclusive medical school that values all staff, and we are happy to consider job share applications and requests for flexible working arrangements from our employees. University Grade 8 (£38,511 – £45,954 p.a pro rata) depending on qualifications and experience Informal enquiries regarding the post should be directed to Jane Nixon, +44 (0) 113 343 1477, ctrujobs@leeds.ac.uk If you have any specific enquiries about your online application please contact +44 (0) 113 343 1477, ctrujobs@leeds.ac.uk Job Ref: MHCTR1032 Closing Date: 26th October 2015 Job Description Role Summary The post-holder will provide clinical expertise and coordinate and support the design and delivery of a portfolio of pressure ulcer and wounds research. Working with the Professor Jane Nixon (Chief Investigator), and other co-applicants including senior academic and NHS colleagues in Leeds, clinical nurse specialists across 40 acute and primary care Trusts, Leeds based Research Fellows, the LICTR team and the Leeds Teaching Hospitals RM&G and Finance Departments, Main Duties and responsibilities Strategy and Leadership Contribute to the development of strategic direction and strategy development of the LICTR Comprehensive Research Division and Skin Portfolio from an NHS perspective. Take a strategic approach to the development of partnership working with academic and NHS organisations, including the developing clinical research networks to ensure the infrastructure is present to support the pressure ulcer and wounds research. Identify from the programme implementation and results issues with strategic implications to the NHS. Develop strategic partnerships with NHS organisations including commissioners to translate the research outputs across acute and primary care. Research Excellence and Research Conduct Work in partnership with Professor Jane Nixon to develop further grant applications and implement high quality research. Promote the academic profile of the LICTR through contribution to high quality publications in peer-reviewed clinical and methodological journals. Present research and/or issues in study design and conduct at local, national and international conferences. Work in partnership with the project lead, contributing to research protocol development and implementation from a clinical expert/NHS perspective. Research Management and Supervision Ensure effective communication between all partners in the research grants, including funder’s applicants, Data Monitoring and ethics committee, Steering Committees, partner NHS and academic organisations, Tissue Viability Nurse Specialists/Consultants, clinical research nurses and associated clinical teams. Set up Management systems to maintain an overview and monitor progress including current and planned timelines, budget handling and resources. As a key member of the project team co ordinate research activity across the portfolio of research Establish and maintaining professional relationships with academic and clinical collaborators participating in the portfolio of research. Take a lead role in negotiating with clinical leads their membership of trial teams, ensuring adequate clinical expertise and input. Lead negotiations with NHS and academic organisation in relation to their specific involvement in the implementation of the research projects Agree budgets with each NHS organisations including clinical research nurse resource requirements and models of working across NHS Trusts Working in partnership with the participating NHS organisations to appoint and coordinate the clinical research team (ie across NHS organisations and staging their involvement in concurrent projects). Negotiate additional clinical research nurse and other NHS resource through the Local Clinical Research Networks. Ensure that the clinical research nurse team members have adequate local accountability and management arrangements and fulfil research governance and professional requirements. Working in partnership with the participating centres to manage the performance of the clinical research nurse team. Planning and generating publicity for the research portfolio of studies. Quality Assurance and Regulation Ensure that all projects fulfil approval and research governance requirements, developing strategies and systems for quality assurance for the programme of work. Develop an understanding of the LICTR QA system and identify common standards and requirements for project teams (eg version control, data protection, protocol development, ethical submissions). Liaise with project leads, research fellows and the LICTR QA team, co-ordinating training for non LICTR research staff. Monitor standards across all projects against agreed portfolio standards. Ensure that appropriate security measures are in place to prevent unauthorised access to patient named data in accordance with the Data Protection Act, in liaison with the Assistant Director (Information Systems). Administration Set up and co-ordinate project oversight committees including Management Groups and Steering Committees Act as a key line of communication and producing written reports to the funding body, sponsor, the UKCRN Co-ordinating Centre, members of the Steering Committees and regulatory authorities as required. Manage the Senior Trial Co-ordinator ensuring effective appraisal and individual personal development plans. Support the LICTR Senior Management Team in team and role development. Support the LICTR Senior Management Team and Scientific Advisory Committee in implementation of LICTR strategy and associated developments. Advise the Operations Director, Head of Trial Management and Business Manager of resource requirements including estates, IT and staffing resource needs for the portfolio of studies. Maintain an overview of and manage NHS components of the portfolio of studies budget, liaising with the NHS Finance Managers as required. Teaching and Learning Support Contribute to the LICTR’s internal and external post-graduate training and education programmes. Develop, co-ordinate and evaluate training for clinical research nurses, Tissue Viability Nurse Specialists and NHS staff in research related roles and responsibilities and practice development. Specialist Knowledge/professional responsibility Maintain active status on the NMC register. Act always in accordance with the NMC Code of conduct and guidance documents. Maintain a high level of awareness of NHS organisational issues including commissioning. Maintain a high level of awareness of nursing research and practice issues and in particular current issues in tissue viability. Maintain a professional portfolio. Take responsibility for personal development and education with regard to revalidation, Personal Development Plan objectives and KSF. Relationships The post-holder is responsible to Professor Jane Nixon, Leeds Institute of Clinical Trials Research through whom he/she is accountable to the Head of Institute, Professor Julia Brown, the Dean of the Medical School, Professor Paul Stewart and ultimately the Dean of the Faculty, Professor Peter McWilliam. Key working contacts will include: Deputy Director LICTRU Study management Groups (including co-applicants (senior academic and senior NHS staff) Study Steering Committees (including national and international academics) Tissue Viability Nurse Specialists/Consultants in lead clinical centres (approximately 40) LICTR team including Director LICTR, skin portfolio statisticians and Trial Management/data management teams LICTR Business Manager Regular liaison with: RM&G managers for all participating centres Local Clinical Research Networks United Kingdom Clinical Research Network Local, national and international research groups A range of national and international organisations concerned with clinical research. University Values All staff are expected to operate in line with the university’s values and standards, which work as an integral part of our strategy and set out the principles of how we work together. More information about the university’s strategy and values is available at http://www.leeds.ac.uk/comms/strategy/ Professional Registration As a qualified Nurse, you should have up to date registration with the NMC. You will be required to maintain such registration so long as you remain employed with the University of Leeds. You should produce registration upon request. Person Specification Essential Education A Registered Level 1 Nurse Educated to degree level in nursing (or another health related subject) Experience/knowledge Solid NHS experience in acute and/or primary care environment Evidence of leading and facilitating Trust wide evidence based nursing practice in the NHS using clinical audit (or similar) methodology Evidence of setting up/co-ordinating critical incident systems in a clinical environment Experience of setting up and facilitating collaborative working arrangements with specialist/consultant nurses, medical colleagues and senior NHS managers to develop practice and effect change. Experience and ability to participate constructively in complex multi-disciplinary meetings and decision making processes General understanding of the research governance environment in the UK Experience in the implementation of research in the clinical environment within the therapeutic area of pressure ulcer prevention/wounds Experience in developing, implementing and monitoring policies, guidelines and standards in clinical practice Experience in staff management and development. Skills and abilities Effective organisational skills demonstrated by proven ability to prioritise work and successfully manage and complete projects Negotiation and facilitation skills Ability to work effectively both independently and collaboratively. Demonstrates capacity for original thought and to solve problems, identify issues and plan strategic action Effective communication and presentation skills. Well developed interpersonal skills and the ability to work with collaborators at all levels Computer literate Physical capabilities Current and valid driving licence Able to travel to research centres Desirable Education Post graduate qualification in nursing or other health related subject Knowledge/experience Evidence of leading cross NHS organisational boundary change Knowledge of consensus development methods in clinical practice development or research Experience of user involvement in clinical practice development or research Experience of regional or national project work/collaboration/initiatives Experience as an NHS Principle investigator for multicentre studies Further Information Faculty Information With more than 6,000 students, 1,600 staff and annual research income of £50m, the Faculty of Medicine and Health at Leeds is bigger than some universities. Leeds has one of the largest medical and bioscience research bases in the UK, and is an acknowledged world leader in cancer, cardiovascular, psychiatric, genetic, musculo-skeletal and health services research. Treatments developed in Leeds are transforming the lives of people around the world living with conditions such as HIV, TB, diabetes and malaria. The School of Medicine The School of Medicine at the University of Leeds is a major international centre for research and education. Our ambition is to improve health and reduce health inequalities, locally and globally, through excellent scientific research and the translation of that research into healthcare practice, and through the education of future scientific and clinical leaders who will advocate and practise an evidence-based approach. Our major strategic aims are to: Deliver outstanding research including basic discovery science through to applied health research that makes a significant difference to health. Produce exceptional graduates, clinicians, educators, doctoral and post-doctoral fellows whose learning has been informed and inspired by our research excellence and who will form the next generation of academic and clinical leaders. Develop and support knowledge transfer activities that flow from our academic activities. Create and maintain an efficient and sustainable environment for research and teaching within an organisational culture and management style that enacts and supports the university’s core values of community, inclusiveness, integrity and professionalism. The School of Medicine is organised into seven Institutes. All are committed to high quality research-led teaching, through their training of postgraduate research students, delivery of postgraduate taught courses, and its leadership in undergraduate teaching. The School works closely with the local NHS, having a number of jointly funded clinical posts to ensure this relationship is effective and strong for both research and student education. Leeds Institute of Cardiovascular and Metabolic Medicine (LICAMM), Director: Professor Mark Kearney LICAMM integrates basic and clinical scientists with a common goal of understanding the mechanisms underpinning common chronic diseases of human health and developing new approaches to treating patients at an individual and population level. At the heart of LICAMM’s philosophy is a vibrant multidisciplinary approach to science that provides a platform to deliver internationally competitive translational research and teaching in disorders including cardiovascular disease, diabetes, cancer and neurodegenerative diseases) our key aim is to improve the lives of our patients and the experience of our students. Leeds Institute of Health Sciences (LIHS), Director: Professor Tim Ensor LIHS delivers problem-driven research that supports decisions about the content or delivery of healthcare. Our interdisciplinary approach incorporates expertise in applied health research designs, health implementation sciences, social sciences, health economics, informatics and statistics, as well as skills in communicating with basic scientists, policy makers, healthcare providers, public and patients. We conduct research at the individual, population and organisational level. Leeds Institute of Medical Education (LIME) Director: Professor Trudie Roberts LIME provides the administrative support, co-ordination and leadership for the School of Medicine’s undergraduate medical degree, including admissions, curriculum development, assessment, student support and clinical placement liaison. It provides the technologyenhanced learning and innovation support for the School of Medicine. LIME also has a very active scholarship programme of research and innovation in medical education and uses its expertise to influence medical education policy and practice nationally and internationally. To achieve this it works with a range of stakeholders including the academic community, the profession, the public, regulators and policy makers. The Leeds Institute of Cancer Studies and Pathology (LICAP) Director: Professor Tim Bishop The Leeds Institute of Cancer Studies and Pathology addresses both laboratory based and clinical research into cancer with a major focus on translational science. LICAP is one of the largest cancer Institutes in the country and has major financial support from the cancer charities. The laboratories and clinical research are all based on the St James’s site with laboratory activities being located in the Wellcome Trust Brenner Building and adjacent buildings while the clinical work is based within Bexley Wing. Leeds Institute of Biomedical & Clinical Sciences (LIBACS) Director: Professor Philip Hopkins LIBACS undertakes clinically-driven research from the level of the gene through cellular, tissue and organ to clinical trials. Our vision is to develop a sustainable centre of excellence for the advancement of patient care by translating research results into clinical practise and contributing to medical education at undergraduate and postgraduate levels. Our research interests are encapsulated in 6 clinical themes (Gastrointestinal inflammation & tumorigenesis, Genetic disorders, Infection & immunity, Neuroscience, Perinatal medicine, Perioperative outcomes & technologies) underpinned by 4 generic science technology strands (Animal models, Cell biology, Gene regulations & Genomics). We are based predominantly at the St James’s University Hospital site. Leeds Institute of Rheumatic and Musculoskeletal Medicine (LIRMM), Director: Professor Paul Emery LIRMM is dedicated to improving diagnosis, therapy, intervention and outcome across the spectrum of rheumatic and musculoskeletal medicine. It boasts a dynamic portfolio of research and education, delivering wide-ranging clinical, translational and basic research across five Sections: Clinical Musculoskeletal Medicine, Experimental Musculoskeletal Medicine, Clinical Biomechanics and Physical Medicine, Rehabilitation Medicine and Orthopaedics. A multi-disciplinary approach is the core of our activities, with significant interdisciplinary links between Experimental and Clinical research. LIRMM’s clinical activities are focussed at Chapel Allerton Hospital, which is also base for our NIHR Musculoskeletal Biomedical Research Unit (LMBRU) and our basic sciences at St James’s University Hospital. Leeds Institute of Clinical Trials Research (LICTR) Director: Professor Julia Brown LICTR delivers innovative design, delivery and knowledge transfer in clinical trials research. Our multidisciplinary approach, in collaboration with basic scientists, clinicians, policy makers, healthcare providers, public and patients and University colleagues, delivers internationally competitive research and teaching that makes a significant contribution to the evidence base for healthcare delivery. The Institutes research is conducted through the Clinical Trials Research Unit where we have expertise in design and conduct of complex clinical trials incorporating novel designs to evaluate CTIMPs, complex interventions, diagnostics, medical devices and surgery. Clinical Trials Research Unit (CTRU) The CTRU is a National Cancer Research Institute (NCRI) accredited and UKCRC Registered Clinical Trials Unit. It has a national and international reputation for the design and delivery of innovative, complex, and rigorous multi-centre early to late phase clinical trials. The CTRU provides multi-disciplinary academic leadership with input to all aspects of trials activity, including statistical design, protocol development, randomisation, development of outcome measures, data management, logistical issues, statistical analysis, interpretation of results and publication. Both the CTRU’s track record in conducting innovative, complex clinical trials and its associated methodological research (efficient trial design and analysis, novel outcome measures and patient reported outcomes, electronic data capture) inform the academic development of this specialised field of clinical research on a national and international level. The CTRU particularly specialise in efficient phase 1/2 trials, biomarker driven designs, seamless phase2/3 designs, adaptive designs and development and evaluation of complex interventions. The CTRU is organised into three therapeutic area divisions cancer, health sciences, comprehensive) underpinned by a cross cutting methodology division, within which the portfolios reflect both national priorities and strengths in Leeds: Cancer Research Division - Co Directors Prof Julia Brown & Prof Walter Gregory - Solid Tumours Portfolio - Haematological Oncology Portfolio - Psychosocial Portfolio - Early Phase Trial Portfolio Health Sciences Division - Director Prof Amanda Farrin - Mental Health Portfolio - Diet and Obesity Portfolio - Older People Portfolio - Stroke Portfolio - Complex interventions portfolio Comprehensive Health Research Division –acting Directors Prof J Nixon, Prof J Brown - Cardiovascular Portfolio - Musculoskeletal Portfolio - Oral Health Portfolio - Skin Portfolio Methodology Division - Directors Prof Walter Gregory, Prof J Brown, Prof A Farrin, Prof J Nixon - Statistical Methodology - Efficient trial design - Outcome development - Complex intervention development - Data capture The CTRU is currently undertaking approximately 100 trials/studies including methodological studies that underpin scientific rigour in our trial design and analysis. The CTRU has approximately 130 staff members and grant income is approximately £5 million per annum. Grants have been achieved from a variety of funders: NIHR, MRC, Cancer Research UK, BHF, ARUK, Wellcome, LRF, EORTC, European Union Biomed Programme and a variety of Pharma companies. Enterprise and Knowledge Transfer National Networks LICTR hosts and provides the leadership for the UKCRC Registered Clinical Trials Unit Network and the NIHR Trial Managers Network. Research Design Service LICTR provides the academic leadership for the Leeds hub of the NIHR Yorkshire and Humber Research Design Service and provides research design advice and consultancy through the RDS. Teaching LICTR is committed to high quality research-led teaching and provides training of postgraduate research students and delivery of postgraduate taught courses. St James’s University Hospital Campus Infrastructure and Facilities (SCIF) Director: Professor Pam Jones This group covers activities that cover School of Medicine functions for Institutes at St James’s University Hospital that span more than one institute including biomedical research facilities, student education, IT, health and safety, estates, seminars, PGR studentships and business support functions. These functions help support the 5 adjacent buildings on the site. There are 3 Institutes with staff and students at St James’s: LICAP (Leeds Institute of Cancer studies and Pathology), LIBACS (Leeds Institute of Biomedical and Clinical Sciences), LIRMM (Leeds Institute of Rheumatic and Musculoskeletal Medicine). These three institutes are dedicated to basic, translational, clinical and health research integrated with student education. Additional Information Terms and Conditions Details of the terms and conditions of employment for all staff at the university, including information on pensions and benefits, are available on the Human Resources web pages accessible via the links on the right hand side, or at http://hr.leeds.ac.uk/policies Disclosure and Barring Service checks A Disclosure and Barring Service (DBS) Check is not required for this position. However, applicants who have unspent convictions must indicate this in the ‘other personal details’ section of the application form and send details to the Recruitment Officer Disabled Applicants The post is located in the Leeds Institute of Clinical Trials Research. Disabled applicants wishing to review access to the building are invited to contact the department direct. Additional information may be sought from the Recruitment Officer, email disclosure@leeds.ac.uk or tel + 44 (0)113 343 1723. Disabled applicants are not obliged to inform employers of their disability but will still be covered by the Equality Act once their disability becomes known. Further information for applicants with disabilities, impairments or health conditions is available in the applicant guidance.