Faculty of Medicine and Health s1

Faculty of Medicine and Health

School of Medicine

Leeds Institute of Rheumatic and Musculoskeletal Medicine

Clinical Research Fellow ALPHA Study

This post is available from July 2015 for 3 years

A Clinical Research Fellow with an interest in Dermatology is required to support a NIHR HTA funded multicentre study on severe Hand Eczema (ALPHA). This post offers the opportunity to develop research skills and clinical experience in Dermatology.

Working with Dr Miriam Wittmann and the Clinical Trials Unit you will be responsible for the day to day coordination of the ALPHA study from set-up and recruitment through to trial end of patient recruitment and follow up. You will take a lead clinical role in the provision of advice to the sites and research teams involved and in recruiting and treating patients involved in clinical studies. You will also support the management of other eczema related research projects as necessary. The post requires working with key team members across Leeds and Bradford Dermatology Departments and the University of Leeds.

You will be medically qualified and have completed Foundation training or equivalent. You will be required to have GMC registration by the time of taking up the position. Applicants will have a strong background in effective communication, organisational and prioritising skills. Whilst previous experience of working within a research setting is not essential you must be able to demonstrate your ability to undertake research duties. Clinical experience within Dermatology would be advantageous

This post is available immediately for initially 3 years and will be based across Chapel Allerton Hospital, Leeds and St Luke’s Hospital, Bradford.

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.

The salary will be on the Medically Qualified Research Fellow scales for Clinical Academic staff (up to £39,693 p.a. due to funding restrictions) depending upon relevant qualifications and experience.

Informal enquiries regarding the post should be directed to Miriam Wittmann, email: .

If you have any specific enquiries about your online application please contact Gayle Iype, tel: +44 (0)113 392 4884 or email:

Job Ref: MHLRM1015 Closing Date: 2 August 2015

Purpose of the post

This post is based in the Leeds Institute of Rheumatic & Musculoskeletal Medicine and Leeds Teaching Hospitals NHS Trust within Chapel Allerton Hospital but you will also work at Bradford Teaching Hospitals Foundation Trust (St Luke’s Hospital). The Leeds Institute of Rheumatic & Musculoskeletal Medicine, University of Leeds works in close collaboration with the Department of Dermatology within the Leeds Teaching Hospitals NHS Trust.

Severe Hand Eczema is often a chronic condition, which can significantly impair the quality of life. The ALPHA study will compare different treatment (in the first line Alitretinoin and PUVA) pathways for this condition and monitor the longer time effect (follow up for 1 year). This post is required to support this large, UK-wide multicentre study by working closely with the ALPHA study team at Leeds Clinical Trials Unit and Chapel Allerton Hospital. The post-holder will report directly to Dr Miriam Wittmann (Chief Investigator), the Director of the Leeds Institute of Rheumatic and Musculoskeletal Medicine and Dean of the School of Medicine.

Supervision and support will be provided by the Chief Investigator (Dr M Wittmann). You will develop specialist dermatology knowledge relevant to the post.

Main Duties and responsibilities

The major role of the applicant will be to conduct clinical research in Eczema as part of the ALPHA study. Working with the study team, you will help to co-ordinate and project manage the study as well as recruit patients at both Leeds and Bradford centres. You will need to identifying and recruiting patients into the study and supporting the wider study in its clinical element where necessary. Whilst previous dermatology experience would be advantageous, it is not essential as study specific training will be available.

Clinical Project/Study Management

·  With Chief Investigator (CI) delegation, take responsibility for the successful day-to-day running and coordination of eczema research activities related to the ALPHA study

·  Conduct a high-quality research study, contributing to the development of the study and contributing your own ideas, under appropriate supervision and guidance

·  Make and contribute to decisions on day-to-day matters that affect your own work and that of the team.

·  Communicate with local clinicians, and with clinicians at other participating sites (and referring GP practices if appropriate), ensuring that they are aware of the study status and have access to relevant documents, to ensure appropriate referral and compliance with the protocol.

·  Support recruitment and data quality and flagging any problems early.

·  Assist with set-up of new sites, helping with site initiation visits and recruitment at initiated sites.

·  Identify issues that may affect planned delivery and identify and implement solutions. Help to overcome practical and administrative barriers to efficient running of the studies.

·  Maintain a thorough and up-to-date understanding and working knowledge of the EU Directive on Clinical Trials, ICH Good Clinical Practice (GCP) guidelines, Human Tissue Act, and the Research Governance Framework ensure adherence to all applicable regulatory requirements.

·  Keep abreast and maintain a good working knowledge of the relevant literature and current developments in the field of the project.

·  Present your research data at a local and international level and contribute fully to the activities of the multidisciplinary team.

·  Write up the results of your work, leading to high quality publications in peer-reviewed journals, as appropriate.

·  Contribute to the work of the research team as a whole; through dialogue with colleagues, generation of ideas, contributing to preparation of grant applications, advising on study design, problem solving etc.

·  Attend departmental and institute research seminars and meetings and undertake training courses where required.

·  Build internal and external contacts and participate in internal networks for the exchange of information and for future collaboration.

·  Develop excellent effective working relationships within the multidisciplinary group. Build excellent working relationships with the Clinical Trials Unit Team, the Section and with NHS Partners.

Clinical Duties

The post will take on the responsibility of clinical sub-investigator at both Leeds and Bradford sites and will take a lead role in guiding the identification, recruitment and treatment of study patients in line with the relevant protocols.

You will also offer clinical advice for the wider study including study partners, the Leeds Clinical Trials Research Unit (CTRU). You will also work within routine dermatology clinics as this is where the patient cohort will be primarily identified.

The successful applicant will be expected to have GMC registration by the time the position starts and will be required to complete Good Clinical Practice (GCP) training as soon as practical after appointment.

General

·  Act as a main clinical point of contact and communication for the studies.

·  Facilitate effective communication both within the research team, and with referring clinicians, patients and the public. This will involve producing progress reports, facilitating teleconferences and face-to-face meetings of the research team/collaborators, preparing newsletters, website information.

·  Manage your own time effectively, taking into account other members of the research team.

·  Adopt a flexible approach to work, and be willing to participate in training, patient recruitment and site initiation/recruitment.

·  Travel within Yorkshire and to centres elsewhere in the UK will be required, particularly between Chapel Allerton and St Luke’s Hospitals.

·  Carry out the duties of the post in accordance with the University values and standards in line with University policies and procedures and local faculty/school benchmarks as appropriate.

·  Maintain a safe work environment, including ensuring compliance with legislation and the undertaking of risk assessments.

·  Maintain own continuing professional development.

Teaching

Although no formal teaching requirements will be made of fellows, they may be expected to share in these tasks on an occasional basis, contributing to the teaching activities of the group.

The job description provides a framework for the role of the clinical ALPHA Trial Coordinator and should not be regarded as a definitive list of duties and responsibilities, which will develop and change over time through natural progression.

Relationships

You will be directly responsible to Dr Miriam Wittmann (CI, ALPHA study), and ultimately to the Head of the institute (Prof Paul Emery) or his/her nominee through whom he/she is accountable to the Dean of the Medical School and Faculty, Professor Paul Stewart.

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/

Person Specification

Essential

·  Medically qualified (MBChB or equivalent).

·  Have completed Foundation training (or equivalent).

·  An interest in Dermatology.

·  Current GMC registration (or fulfilling all requirements for GMC registration and have GMC registration prior to taking up the post).

·  Effective interpersonal and communication skills, including presentational skills and ability to undertake written reports.

·  Display an enthusiasm for learning appropriate new research techniques.

·  A capacity for original thought that will enable you to develop an individual research interest.

·  Evidence of an ability to write to a standard required for research reports/publications (at least co-authorship of peer-reviewed publications, including case reports).

·  The ability to demonstrate a professional approach to planning, setting objectives and working flexibly to fulfil the needs of the research.

·  Willingness to learn about ICH GCP, the Medicines for Human Use Act (2004), the Human Tissue Act, and the Research Governance Framework.

·  Excellent IT skills and relevant working experience of Microsoft Word, Excel, PowerPoint, and Outlook.

·  Proven ability to pay attention to detail and maintain accuracy.

·  Able to work autonomously where required, and to use initiative.

·  An understanding of how to deal with sensitive situations confidentiality.

·  Willingness to learn about inflammatory skin diseases and to maintain an up-to-date knowledge of the clinical research environment.

·  Available and willing to undertake regular travel within the Yorkshire region to facilitate patient recruitment, and less frequently to other hospital sites in the UK.

·  Ability to develop effective working relationships with a wide range of people at all levels, across a range of organisations.

Desirable

·  Have completed Core Medical Training (or international equivalent).

·  Experience of working in Dermatology at ST1 or later or (equivalent international level).

·  Passed Membership of the Royal College of Physicians (UK) examination or equivalent (international qualifications will be considered).

·  Previous experience of working in a medical/clinical research environment.

·  Demonstrated clinical experience in dermatology.

·  An understanding of academic challenges facing eczema research.

·  Experience of working within the clinical research environment, including recruiting patients to studies / experience in clinical trials research.

·  Previous experience as clinical trials sub investigator.

·  Completed GCP training within the past 12 months.

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 LICAMMs 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