FURTHER PARTICULARS

Job title Clinical Research Associate

Grade CRA

Salary range £31,301 - £54,199

Staff Group Research Staff

Department / Institution Clinical Neurosciences – John van Geest Centre for Brain Repair

Role Purpose

The post holder will be responsible for helping conduct and coordinate clinical research at the John Van Geest Centre for Brain Repair into Parkinson’s and Huntington’s diseases, with a particular focus on the pharmaceutical led drug studies as well as academic studies in experimental medicines, ensuring they are conducted according to ICH Good Clinical Practice guidelines and department safeguards for the well-being of patient/study participants.

The successful candidate will take a leading role in the commercial clinical trials conducted at the Brain Repair Centre which are all Phase I/2a studies in Parkinson’s and Huntington’s disease and this will include new experimental trials with gene therapies, vaccines and cells. They will also be responsible for the weekly PD research clinic which is conducted at the Brain Repair Centre; this includes the longitudinal follow up of patients in the PICNIS and ICICLE studies. Our Department emphasises good interactions within and between clinical research groups in Cambridge, and collaborations with outside groups. The role will involve setting up studies (including ethical approval) and subsequent recruitment and testing of participants and analysis of data.

The purpose of this role is to support and maintain the University’s national and international reputation for excellence in teaching and research. Contribution to excellence in research will be as a member of a research team carrying out research at a similar level to that undertaken by lecturing staff and will provide substantial scope for academic judgement, originality, interpretation and presentation of results. The role holder will assist with grant administration and the writing of reports for funding bodies.

This post would offer excellent research training in an outstanding and vibrant research environment to those pursuing a career in Neurology. It is anticipated that applicants would wish to study for a PhD or MD, which would be encouraged for suitable candidates.

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Key duties and responsibilities % time spent/ frequency

Recruitment of Patients and Patient Care Identifies strategies for the retention of suitable patients for the studies. Provides care and support for patients. Responsible for all patients in the study including trial and clinical care

and consent. Administer drugs and therapeutic agents as well as monitor the treatment

of patients, including venepuncture, and collection of biosamples. Acts as the primary contact for the patient and provides ongoing

information and support, including referral to other specialists for their complete care.

15%

Clinical Assess protocols and advise on safety, regulatory and logistical issues

for the set-up and running of the study/trial to ensure the well-being and safety of patients, participants and staff.

Provide participants with specialist information regarding their participation, including risk factors.

Provide a high standard and continuity of care for participants during the research study, maintaining lines of communication with clinical staff.

Act as a resource to participants, their families and staff from within the clinical area, providing information and support; and to act as an effective referral to other support agencies where necessary.

Achieve and maintain defined ‘competencies’ for clinical research to ensure that capability, skill and knowledge are appropriate for the work undertaken.

Work within dedicated clinical research teams; ensure ethical and clinical safe practice.

Undertake, with appropriate training, interventional treatments directly to participants according to study/trial protocol and procedures and record the resulting information.

Undertake and process clinical samples (e.g. venepuncture/cannulation/CSF analysis) with appropriate training, for studies, co-ordinate tissue sample collection and dispatch to relevant departments or trial centers as appropriate.

Maintain clinical skills as appropriate e.g. phlebotomy, vital sign assessment, patient compliance, ECGs.

Undertake research-associated laboratory work safely, as required. Attend relevant outpatient clinics to assist with recruitment, to monitor the

progress, and to collect data of participants involved in the study/trials. Attend inpatients involved in clinical trials as necessary.

Work at all times as part of the extended multidisciplinary team and maintain excellent links with staff in clinic, ward and treatment areas regarding the protocol care required for study/clinical trial participants.

Retrieve and retain medical records of participants for trial duration.

30%

Research Conduct research according to standards and regulations laid down in

ICH Good Clinical Practice and EU Directives, and to the most current guidance relating to Research Governance and Research Ethics.

Assist in the provision of background information about potential clinical trials to obtain approvals from Research Governance and Local Ethics Committees.

Co-ordinate and manage research within expected timelines. Work within and contribute towards the development and review of

30%

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Standard Operating Procedures (SOPs) and local policies/procedures for clinical research.

Support actively the process of gaining ethics approval for research studies.

Understand the requirements of the study protocol and adhere to them. Identify suitable participants eligible for the study/clinical trial, in

conjunction with the site investigator; identify, screen and recruit research participants using detailed knowledge of the protocols for the designated site specific groups.

Prepare patient/participant documentation for treatment clinics with meticulous attention to detail

Develop research objectives, projects and proposals; Conduct individual or collaborative research projects; Identify sources of funding and contribute to the process of securing

funds; Extend, transform and apply knowledge acquired from scholarship to

research and appropriate external activities Write or contribute to publications or disseminate research findings using

other appropriate media Assess, interpret and evaluate outcomes of research; make

presentations at conferences or exhibit work in other appropriate events; Routinely communicate complex and conceptual ideas to those with

limited knowledge and understanding as well as to peers using high level skills and a range of media;

Responsible for the delivery of own research programmes

Communication Liaise closely with the Principal Investigator/Research Team and all

relevant specialist nurses, providing necessary research related information as required.

Liaise with members of the departments at the investigator site who are involved in the conduct of specific trial procedures, such as pharmacy, biochemistry and diagnostic units.

Liaise with clinical trial centres and units as necessary and with relevant departments in order ensure smooth running of clinical trials for patients.

Liaise with the clinical trial personnel from the research sponsors regarding ethical, organisational, managerial, monitoring and financial aspects of the trial.

Facilitate communication between the research sponsor and support departments involved in the research.

Communicate effectively with research participants on all aspects of clinical research.

5%

Management Manage and organise own workload within study/clinical trial

requirements. Supervise staff conducting trial-related activities that contribute to

the overall co-ordination of the individual research projects. Ensure that all proposed research projects carried out in the department

are registered and authorised by the Trust Research Department and Research Ethics Committee (REC) prior to commencement.

Undertake the practical organisation and management of trial participants and the administration of information.

Ensure that updates and amendments are reported in a timely fashion. Prepare for and facilitate audit by the Trust Research Department and/or

10%

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Regulatory Authorities for GCP compliance.

Liaison and networking: Collaborate actively within and outside the Institution to complete

research projects and advance thinking Develop links with external contacts such as other educational and

research bodies Originates and develops external networks, for example to identify

sources of funding, generate income, obtain consultancy projects, or build relationships for future activities.

5%

Planning and organising: Plan, co-ordinate and implement research programme/s; Manage the use of research resources and ensure that effective use is

made of them;

5%

Person profileEssential knowledge, skills and experience required for role

Education & qualifications

Medical degree. Must be licensed to practise medicine in the UK Possession of MRCP or equivalent

Specialist knowledge & skills

Knowledge of patient based research and clinical trials including informed consent and GCP would be desirable

Will possess sufficient breadth/depth of specialist knowledge in the area of Neurology and of research methods and techniques to assist with developing research objectives, projects and proposals

Previous research experience in a related areas would be an advantage

Excellent report writing and presentation skills

Will continually update knowledge in the specialist area and engage in continuing professional development.

Experience of managing own workload.

Use initiative and creativity to solve routine problems in relation to research projects, e.g methodological, technical, financial problems

Interpersonal & communication skills

Good written and spoken English Ability to work independently but also able to operate effectively

within multi-disciplinary teams and across professional disciplines

Excellent interpersonal and communication skills: ability to develop good working relationships with diverse study participants, healthcare professionals and external agencies

Able to support participants through the informed consent process

Good organisational, time & project management skills: and able to plan, prioritise & co-ordinate work under pressure

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Good presentation skills Numerate with good IT skills; competent in standard PC

packages (Windows, Microsoft Excel, Microsoft Access) Proven administrative skills with attention to detail Competent in research/database PC packages

Relevant experience Ideally but not essential to have experience of co-ordinating REC and MHRA submissions

Experience of working in a clinical research environment e.g. Clinical Trials, participant recruitment and interviewing

Additional requirements

Clinical neurology experience Able to work flexible hours with occasional evening and

weekend working (e.g. for study recruitment) Willingness to travel regionally/nationally

Summary of Terms & Conditions

Location:John van Geest Centre for Brain Repair, Forvie Site,Addenbrooke’s Hospital, Cambridge

Limit of Tenure: Up to 12 months in the first instance.

Annual Leave:

Full time employees are entitled to annual paid leave of 6.6 weeks (or 33 days) for those working full time, plus public holidays. The leave year runs from 1st October – 30th September.

Hours of work: This appointment is full-time.

Pension:

The Universities Superannuation Scheme is a national scheme for employees on academic, research and academic related scales of pay which covers all the pre-1992 Universities and a number of other educational and research bodies. Universities Superannuation Scheme (USS)

Probation: 6 months

ADDITIONAL INFORMATION

Position: Clinical Research Associate

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School: Clinical Medicine

The Department of Clinical NeurosciencesThe Department of Clinical Neurosciences, which is based on the Addenbrooke’s Hospital site, is part of the School of Clinical Medicine. The department was formed in 2004 and brings together the University units of Neurology and Neurosurgery, the Cambridge Centre for Brain Repair and the Wolfson Brain Imaging Centre, alongside the existing Addenbrooke’s NHS Trust Clinical Directorate of Neurosciences. The emphasis of research is on basic and applied neuroscience with the specific aims of understanding mechanisms of injury and repair in common diseases of the central nervous system. The clinical emphasis is on demyelinating disease, neurodegeneration, behavioural neurology, stroke and brain injury using clinical, genetic, immunological and imaging approaches. The Department was top rated (4*) in the most recent research assessment exercise (RAE 2008).

School of Clinical Medicine

The School of Clinical Medicine at the University of Cambridge (‘the Clinical School’) is one of the UK’s leading medical schools. Its strength is built on close relationships with pre-clinical science and translational partnerships with NHS organisations.

Organisation of the School

The School of Clinical Medicine comprises 12 formal Departments (Clinical Biochemistry, Haematology, Medical Genetics, Medicine – including Anaesthesia and Clinical Pharmacology – Obstetrics and Gynaecology, Oncology, Paediatrics, Public Health and Primary Care, Psychiatry, Radiology, Surgery and Clinical Neurosciences) which map onto service delivery within the University Hospital and undergraduate and postgraduate clinical teaching.

Alongside departments, the School maintains a number of cross-departmental institutes to bring together researchers with cognate interest. At present, there are three institutes: Cambridge Institute for Medical Research; Institute of Metabolic Science and Institute of Public Health with a fourth planned (in Cardio-Respiratory Medical Research).

Excellence in Research

The research of the School is pursued under a number of cross-departmental themes: these include Cancer Sciences, Metabolic Disease including Obesity and Diabetes, Neurosciences and Mental Health, Cardiovascular Medicine, Genetics and Genetic Medicine, Transplantation, Immunity and Infection, and Epidemiology, Public Health and Primary Care. Associated with these major research themes are a number of underpinning themes in which the School has particular research strengths: these include Structural and Cell Biology applied to Medicine, Medical Imaging, Stem Cell Medicine, and Bioinformatics.

Pursuit of the major underpinning research themes is enabled and facilitated by a number of cross-departmental research institutes under the aegis of the School. These include the Cambridge Institute for Medical Research (CIMR) supported by a Wellcome Trust Strategic Award, and including the Juvenile Diabetes Research Foundation/Wellcome Trust Diabetes and Inflammation Laboratory (JDRF/WT DIL), the Institute of Public Health, the Institute for Metabolic Science (opened in October 2007), the Brain Repair Centre, the Wolfson Brain Imaging Centre, the Hutchison/MRC Cancer Research Centre, and the Centre for Genetic Epidemiology. A further

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refurbished (the West Forvie) building housing translational stem cell medicine and laboratories for the metabolic and imaging phenotyping of small animal models of disease opened in mid-2008. There is exceptional existing strength in ‘experimental medicine,’ focused through the Wellcome Clinical Research Facility.

In the Higher Education Funding Council’s 2008 Research Assessment Exercise, the Clinical School with the Department of Pathology received a grade point average of 3.11 across the 8 Units of Assessment to which it made submissions under Main Panels A and B (the highest of any Medical School in the UK) with 80% of its total submission being rated internationally excellent or world leading (3* and 4*).

The School’s strategic plan relates the major themes of basic medical science to the problems that arise in clinical practice. These include: the neurosciences, genetic medicine, endocrinology, cancer, immunology and infection, vascular biology, imaging, public health medicine and general practice. The plan includes developing closer links with the Physical Sciences and Engineering through new appointments. The Cambridge Computational Biology Institute is a cross-School initiative with these and with the School of the Biological Sciences.

Excellence in Partnership

The Clinical School is a member of Cambridge University Health Partners, a partnership between the University of Cambridge, Cambridge University Hospitals NHS Foundation Trust (the main acute trust for Cambridge), Papworth Hospital NHS Foundation Trust (a specialist Cardio-Thoracic Trust) and the Cambridge and Peterborough NHS Foundation Trust (the regional Trust responsible for Mental Health).

Cambridge University Health Partners is based on the Cambridge Biomedical Campus at Addenbrooke’s Hospital. This campus hosts activities from all four of the partners and is the main physical site for two of them. It also hosts institutes and units run by other bodies which make major contributions to the richness of the environment. These include the Medical Research Council, Cancer Research UK and GlaxoSmithKline. Together, the partners are intending to double the size of the Cambridge Biomedical Campus by 2020. New developments will include additional clinical space to accommodate expansion and improvement of healthcare; including the relocation of Papworth Hospital, new research space associated with the clinical developments and a commercial biomedical science park.

University of Cambridge

The University of Cambridge (http://www.cam.ac.uk/ ) is one of the world’s leading universities with an outstanding reputation for academic achievement and research. The University comprises 31 Colleges and more than 150 departments, faculties, schools and other institutions plus a central administration function.

Unified Administrative Service (UAS) is the university’s central administrative function. Offices of UAS are listed here http://www.admin.cam.ac.uk/offices/ .

For maps of all university sites please follow this link: http://www.cam.ac.uk/map/ .

Benefits of working at University of Cambridge

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There is a range of information which you may find helpful on the University’s website: http://www.jobs.cam.ac.uk/ . This includes applying for posts, working at the University and living in Cambridge.

To find out more about the financial, personal and recreational benefits of working at the University of Cambridge, click on headings on the final page of this document to visit current university web pages.

Pre-employment checks requiredAll applicants are legally required to demonstrate the right to work/permission to work in the UK. The requirement for any higher level pre-employment checks is dependent on the role. Any offer of employment will be conditional upon the satisfactory outcome of these checks and whether an outcome is satisfactory will be determined by the University.

Pre-employment checks required for this post are evidence of right to work in the UK and an occupational health clearance.

Equal Opportunities Information The University of Cambridge is committed to a policy and practice which require that entry into employment with the University and progression within employment be determined only by personal merit and by the application of criteria which are related to the duties of each particular appointment and the relevant stipend or salary structure. No applicant for an appointment in the University, or member of staff once appointed, will be treated less favourably than another on the grounds of sex, (including gender reassignment), marital status, race, ethnic or national origin, colour, or disability. If any employee considers that he or she is suffering from unequal treatment on grounds of sex (including gender reassignment), marital status, race, ethnic or national origin, colour, or disability, he or she may make a complaint which will be dealt with through the agreed procedures for dealing with grievances.

Information if you have a DisabilityThe University welcomes applications from individuals with disabilities. Our recruitment and selection procedures follow best practice and comply with disability legislation.

The University is committed to ensuring that applicants with disabilities receive fair treatment throughout the recruitment process. Adjustments will be made, wherever reasonable to do so, to enable applicants to compete to the best of their ability and, if successful, to assist them during their employment.

We encourage applicants to declare their disabilities in order that any special arrangements, particularly for the selection process, can be accommodated. Applicants or employees can declare a disability at any time.

Applicants wishing to discuss with or inform the University of any special arrangements connected with their disability can contact, at any point in the recruitment process, Mrs Jackie Green who is responsible for recruitment to this position. Jackie Green can be contacted by email at jg410@cam.ac.uk or by telephone on 01223 331177.

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For additional guidance and information, applicants can contact the HR Business Manager who is responsible for the department they are applying to via hrenquiries@admin.cam.ac.uk .

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RELOCATION ASSISTANCE

Relocation Expenses Accommodation Service Newcomers service

EMPLOYEE BENEFITS

CAMBRIDGE

Cambridge Festival of Ideas

Cambridge Science Festival

Open Cambridge

FAMILY-FRIENDLY

Childcare Leave/Flexible working Career breaks Nurseries/Play schemes

CAMBRIDGE BIOMEDICAL CAMPUS

Frank Lee Leisure/Sports Centre

Concourse Shops/Restaurants

Parking Facilities

RECREATION

University Sports University Social Club College Entry Local Attractions

WELLBEING

Mentoring Counselling Service Chaplaincy Disability Resources

CAREERS

Study/Sabbatical Leave Unpaid Leave Careers Service

FINANCIAL

CAMBens discounts Payroll giving Shared Equity Scheme Contribution Rewards

TRAVEL TO WORK

CAMBens Cycle/Cars Travel to Work Loan Trains – season ticket Uni4 bus discount

HEALTH

Health Cash Plans BUPA/Dental Discount Eye Test Occupational Health

TRAINING & DEVELOPMENT

Institute for Continuing Education

Personal Development Language Centre