Faculty of Medicine and Health
School of Medicine
Leeds Institute of Rheumatic & Musculoskeletal Medicine
Trauma & Orthopaedics Trial Coordinator
Part-time, 50% of Full time equivalent
Fixed term for 2 years
We are looking for someone with a strong background in managing projects, and working within a clinical trials setting, to become a key member of our research team. You will be responsible for coordinating specific Trauma & Orthopaedics (T&O) research projects and clinical trials from setup and recruitment through to trial closure and analysis.
You will provide a wide range of support for the T&O Research Group’s clinical research activities and the senior academic staff. You will also have responsibility for coordinating the Section studies, monitoring and managing a variety of aspects of the project to ensure it progresses well and to time.
You will possess strong problem solving and analytical skills with experience of establishing and implementing systems and processes to support reliable delivery of projects. You will be educated to degree level or equivalent relevant qualification/experience. Effective communication, organisational and prioritising skills with an ability to meet tight deadlines, along with well developed computer skills and excellent attention to detail are essential.
This post is based at the Worsley Building on the main University campus and is available immediately for a fixed term of 2 years.
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 6 (£25,769 – £30,738 p.a.) depending on qualifications and experience
Informal enquiries to: Anne-Maree Keenan, Leeds Institute of Rheumatic &
Musculoskeletal Medicine tel: +44 (0)113 392 4398, email: a.keenan@leeds.ac.uk
If you have any specific enquiries about your online application please contact Gayle Iype, tel:
+44 (0)113 392 4884, email: g.a.iype@leeds.ac.uk
Job Ref: MHLRM1022 Closing Date: 3 January 2015

Background
This post is based in the Section of Orthopaedics and Trauma Surgery, Leeds Institute of
Rheumatic & Musculoskeletal Medicine based at Worsley Building and the Leeds General
Infirmary
This large clinical Institute now represents one of the largest clinical academic groups for rheumatology and musculoskeletal medicine in the world. The Section of Orthopaedics is strategically focussed on increasing its portfolio of high quality research, particularly via Clinical
Trials.
Purpose of the post
The T&O Trial Coordinator is a key member of the research team and will be responsible for the co-ordination of one or more trials/studies within the T&O research portfolio. Duties of the post will include study set up, collection, computerisation and validation of data in accordance with Good
Clinical Practice, the Medicines for Human Use act (2004) and the Research Governance
Framework as appropriate. You will advise the project team and investigators on the progress of the study from a trial co-ordination, regulatory and logistics perspective and work with the Chief
Investigator (CI) to resolve problems. You will develop specialist musculoskeletal knowledge relevant to the post.
Main Duties and responsibilities
Clinical Trials/Project Management

With CI delegation, day-to-day management and coordination of all clinical research administration for the T&O research portfolio

Offer advice, guidance and management to CIs, Fellows, Researchers and Research
Nurses in all stages of each clinical trial

Draft and co-ordinate ethics and R&D applications and approvals

Provide administrative support to PIs in the preparation of grant applications for new research studies

Implement on-going quality assurance and audit programmes. Raise awareness of quality control within the department, according to Good Clinical Practice guidelines.

Ensure adherence to statutory requirements of the legislation regarding clinical trials of investigational medicinal products and devices

Ensure that essential documents for all studies are well maintained

Work with the Researchers and CI in order to optimise patient recruitment to each trial, by making available all trial details, including patient information sheets, consent forms, GP letters and clear inclusion and exclusion criteria, to all clinicians and nursing staff during clinical sessions
 Work closely with the Institute’s (MSK) Portfolio manager to ensure accurate and timely accrual of trial data

Identify amendments needed as the trial progresses and ensuring all members of the project team are aware of amendments

Contribute to the development of best practice systems through the ability to review existing processes, making recommendations for improvement and implementing agreed changes

Monitor the progress of the project/s including current and planned project timelines, data collection and data quality. Flagging problems to the PI or raising them at project team meetings, working with the PI to identify and implement appropriate solutions, and taking

appropriate action to ensure that documentation and study procedures are updated to reflect any changes

Maintain a thorough and up-to-date understanding and working knowledge of the EU
Directive on Clinical Trials, GCP guidelines and the Research Governance Framework, and experience of applying this knowledge through working practices on the projects you coordinate, development of trial specific Work Instructions and liaising with the CTRU QA manager

Develop specialist knowledge relevant to projects

This post requires the post holder to visit participating sites across the UK
General
You will:

Communicate and give support to all members of the research team as point of contact for expert knowledge in clinical research

Support the delivery of the clinical research portfolio

Aid in education and research staff development

Facilitate effective communication between all levels of research staff

Manage your own time effectively, taking into account other members of the research team

Attend relevant investigator meetings and trial update meetings
You may be required to conduct some work across trust sites or in neighbouring hospitals.
The job description provides a framework for the role of the T&O 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 work closely with James Goulding, Institute Trials Coordinator and report to your line managers, Dr Anne-Maree Keenan and Prof Peter Giannoudis (Head of Section) and ultimately to
Professor Emery (Institute Director).
You will be expected to work closely with other members of the Institute. In addition, you will be expected to develop good external working links with staff in Clinical Trials Team, the wider research community, the NHS Research Networks, the NIHR CRN Coordinating Centre, Clinical
Trials Units, other researchers (professors, clinicians, research nurses etc) national funding bodies and relevant professional bodies and organisations.
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

Educated to degree level or equivalent qualification / experience in health research

Previous experience working in a Clinical Trial setting

Previous experience in drafting, co-ordinate and submitting ethics and R&D applications and approvals

Effective organisational skills demonstrated by a proven ability to support a range of different projects simultaneously with an ability to retain a clear focus on outcomes along with delivering good results

Ability to review situations using strong problem solving and analytical skills to identify, gather and assess relevant information

Experience of establishing and implementing systems and processes to support reliable delivery of projects

Relevant working experience of the Microsoft Office suite, especially Word, Excel, PowerPoint, and Outlook

Ability to write clearly and concisely

Ability to use initiative and apply knowledge to practical situations

Ability to participate constructively in meetings

Ability to prioritise work and manage time effectively, along with the ability to use own initiative, as appropriate

Ability to develop effective working relationships, interact and collaborate with a wide range of professionals, including senior staff, across a range of organisations

Ability to work effectively both independently and in a team

Motivation to maintain up-to-date knowledge of clinical research environment

Enthusiastic, proactive and flexible approach to working in a dynamic and diverse academic organisation

Demonstration of willingness to support team members, share experience and develop good practice
Desirable

Experience of producing reliable and complete reports using effective communication and presentation skills along with evidence of attention to detail

Experience of setting up a multi-centre clinical trial in a quality assured clinical trials environment

Experience of co-ordinating phase III multi-centre clinical trials in a quality assured clinical trials environment

Experience of co-ordinating device clinical trials in a quality assured clinical trials environment

Knowledge of GCP, the Medicines for Human Use Act (2004) and the Research Governance
Framework

Understanding of clinical trial design and feasibility issues

A science degree

Postgraduate research degree

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
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 technology-enhanced 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 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 multidisciplinary 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.
St James’s University Hospital Campus Infrastructure and Facilities (SCIF)
Director: Professor Philip Hopkins
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)and 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
University Teaching and Research Award
The Senate of the University has agreed that all newly appointed staff with a contract of 0.5 FTE and above who have a teaching/ research role and are deemed new to teaching or research in
Higher Education should be required to complete successfully all of the requirements of the
University of Leeds Teaching and Research or an appropriate alternative. Whether or not this applies to you, will be decided as part of the appointment procedure at interview.
Further details of the ULTRA are available at http://www.sddu.leeds.ac.uk/sddu-ultra.html
.
Staff with contracts of less than 0.5 FTE may take the ULTRA provided that they have a broad enough range of teaching, research and assessment to complete the requirements of the
Programme: this will be decided in conjunction with the School and the course providers.
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 Worsley Building. 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.