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  • 1. UCL INSTITUTE OF NEUROLOGY Queen Square UCL Institute of Neurology The Institute of Neurology is a specialist postgraduate institute of UCL. The Institute is closely associated in its work with the National Hospital for Neurology & Neurosurgery, University College London Hospitals' NHS Foundation Trust, and in combination they form a national and international centre at Queen Square for teaching, training and research in neurology and allied clinical and basic neurosciences. The Institute website is at: http://www.ion.ucl.ac.uk/. The Institute of Neurology is a member of the newly formed Faculty of Biomedical Sciences at UCL, and has nine academic departments. Seven encompass clinical and basic research within each theme: Neurodegenerative Disease; Molecular Neuroscience; Clinical and Experimental Epilepsy; Motor Neuroscience and Movement Disorders; Imaging Neuroscience; Brain Repair and Rehabilitation; and Neuroinflammation. The remaining two are the Reta Lila Weston Institute of Neurological Studies and the Department of Clinical Neuroscience, Royal Free Campus, both of which are now fully merged with the Institute. In parallel there are currently six divisions representing professional affiliations: Clinical Neurology; Neurosurgery; Neurophysiology; Neuropathology; Neuropsychiatry and Neuropsychology; and Neuroradiology and Neurophysics. The Institute employs a total of around 425 staff, occupies some 6,451 sq m of laboratory and office space in five buildings, and has a current annual turnover of £30m. The Institute receives over £19.1m per annum in grants for research from the principal medical charities concerned with neurological diseases, and from government agencies such as the Medical Research Council. Approximately 19% of the Institute's funding is obtained from the Higher Education Funding Council for England which has awarded high ratings for the Institute in each of the national Research Assessment Exercises since 1986. The Institute currently holds over 250 active grants, supporting research into the causes and treatment of a wide range of neurological diseases, including movement disorders, multiple sclerosis, epilepsy, brain cancer, stroke and brain injury, muscle and nerve disorders, cognitive dysfunction and dementia, and the work of the Institute's clinical academic staff is closely integrated with the Hospital's care of patients. Generous support for research at the Institute of Neurology is provided by the medical charities and especially by the charity, The Brain Research Trust http://www.brt.org.uk The Institute was awarded a Grade 5*A rating (the highest possible rating) in the 2001 Exercise, a measure of its national and international standing. In the calendar year 2005 Institute staff published 584 peer-reviewed papers, 74 chapters and 10 books. Thirty-six papers were published in the top 50 of all scientific journals, including Science, Nature, Neuron, Cell and New England Journal of Medicine. Eight of the thirty most highly cited UK neuroscientists are at the Institute of Neurology, and there are seven Fellows of the Royal Society at Queen Square. A number of important research centres are based at the Institute of Neurology. These include: • Wellcome Centre for Neuroimaging http://www.fil.ion.ucl.ac.uk/ • MRC Prion Unit • MRC Centre for Neuromuscular Disease http://www.ucl.ac.uk/neuromuscular/ • Dementia Research Centre http://www.dementia.ion.ucl.ac.uk/ • Department of Health Dementias and Neurodegenerative Diseases Research Network (DENDRON) http://www.dementia.ion.ucl.ac.uk/
  • 2. We share many research programmes with the Institute of Cognitive Neuroscience, the Gatsby Computational Neuroscience Unit, the Reta Lila Weston Institute, the Royal Free Department of Clinical Neuroscience, the High Field Imaging Laboratory (Department of Engineering and Medical Physics), and also the neuroscience research groups based in our sister Institutes (Institute of Child Health and Institute of Ophthalmology). The Institute of Neurology plays a major role in postgraduate teaching and training. There are over 125 graduate students at Queen Square. The Institute runs a number of graduate teaching programmes, including Master’s degrees in Clinical Neuroscience, Clinical Neurology and Advanced Neuroimaging. It is also making a major contribution to the new London-Paris MSc in Mind and Brain. We attract excellent graduate students of the highest quality through UCL-wide PhD programmes, including the Wellcome 4-year PhD in Neuroscience http://www.physiol.ucl.ac.uk/neurosciencephd/. Institute staff contribute to undergraduate teaching of clinical neurology for the Medical School. Full details of the Institute’s research and teaching activity can be found on the Institute of Neurology website at http://www.ion.ucl.ac.uk Huntington’s Disease and Research Huntington's disease (HD) is a hereditary movement disorder. Huntington's disease usually develops in adulthood (typically between 30 and 50 years old) and can cause a very wide range of symptoms. The symptoms can differ from person to person, even within the same family. Early symptoms may include: mild uncontrollable movements; stumbling and clumsiness; lack of concentration; short-term memory lapses; depression and changes of mood, sometimes including aggressive or antisocial behaviour. Huntington’s Disease is a neurodegenerative disorder. As the disease progresses sufferers may develop many different symptoms which can include: involuntary movements; difficulty in speech and swallowing; weight loss; emotional changes resulting in stubbornness, frustration, mood swings and depression; deterioration of cognitive functions, resulting in a loss of drive, initiative and organisational skills as well as memory and attention problems. Although genetic testing can establish whether people will go on to develop HD there is currently no way of determining either the age at which they will develop the disease or the subsequent rate of progression. The focus of much of the current research is to identify early markers that can predict and track disease progression (biomarkers). Such biomarkers are essential for determining the effectiveness of new treatments at slowing down disease progression. Further details of HD and clinical research conducted by the NHNN clinic can be found on the following website: www.hdresearch.ucl.ac.uk. Track-HD is a multi-centre, multi-national prospective observational study with no experimental treatment. The primary study objective is to determine what combination of measures is the most sensitive for detecting change over the natural course of premanifest and early HD, with a view to validating these as potential outcome measures for use in future therapeutic trials. Subject enrolment commenced in January 2008. There are currently four clinical sites: London, Paris, Leiden and Vancouver which conduct the study in conjunction with Clinical Research Organisations based in Milan (central laboratory), Los Angeles (brain imaging repository), Ulm (data management and monitoring) and London (TRACKHD Central Coordination). There is also ongoing collaboration with a quality assurance team headed by Professor Julie Stout at Monash University, Melbourne. Track-HD is funded by the CHDI Foundation Inc, New York. This is a charitable foundation dedicated to finding treatments for Huntington’s disease. Track-HD aims to assess a variety of measures to determine which measure or combination of measures is most useful (i.e. sensitive and reliable) in tracking disease-related change in HD. These measures include imaging, cognitive and clinical scales as well as markers from DNA and
  • 3. blood. The London longitudinal project at the NHNN has been collecting these data in HD patients since 2003, and has expanded into Track-HD. This study will assess up to 360 subjects at annual visits over three years. Data from Track-HD will be used to identify suitable biomarkers to measure efficacy in future trials of drug therapies. JOB DESCRIPTION Title: Clinical Trial Project Manager, Track-HD Essentials for the role: Substantial international clinical trial project management experience as well as a strong scientific academic background. Department: Department of Neurodegenerative Disease Reports to: Dr Sarah Tabrizi, Reader in Neurology and Neurogenetics, IoN (UCL) and Honorary Consultant Neurologist, NHNN (London) Grade: UCL Grade 9 Working Relationships: Clinical site personnel; Data Managers; Monitors; Key Opinion Leaders in psychiatry, imaging, neuropsychology and neurology; representatives of the CHDI Foundation Inc and European HD Network; administrative and support staff. JOB SUMMARY Organisation of the project The project is funded by the CHDI Foundation, and the Global Principal Investigator (PI) is Dr Sarah Tabrizi, who is based in London. Dr Tabrizi heads a Central Study Coordination Team which is managed by a Clinical Trial Project Manager (this post). Data will be generated at a number of clinical study sites, each managed by a Coordinating PI. The study uses full electronic data capture in conjunction with a data management and monitoring CRO based in Ulm, Germany. From here, analysis organisations will be given access to specific datasets (e.g. the image analysis teams will have access to the imaging data) in order to process raw data. Finally processed data (e.g. brain volumes) will be sent to other organisations/statisticians in order to answer the main question of the study. This is represented in figure 1 below, which shows how the Central Study Coordination team fits into the management structure of the study. Study roles are outlined in table 1.
  • 4. Table 1: Roles of different organisations in Track-HD. EHDN – is the European HD Network and the HQ is based in Ulm, Germany. The data monitors in Ulm = EHDN database manager & direct online data monitoring Advisory Steering Scientific committee committee review board Central Coordination CHDI (London) Data monitors (Ulm) Data BioRep / Study site PIs Managament IXICO Labs Imaging CRO
  • 5. Figure 1: Overview of Track-HD coordination Trial Activities Responsibility Project management and • Central Coordination planning Regulatory documents (IRB) • Central Coordination Conducting investigator • Central Coordination meetings Conducting study expert • Central Coordination meetings Training of personnel •Various International TRACK-HD Researchers under the management of Central Coordination and Professor Julie Stout (TRACK HD Researcher and Professor Neuropsychology, Monash University) and with the support of EHDN. Site identification and • The High Q Foundation selection • Central Coordination Initiation visits • Central Coordination Monitoring visits • Data Management Team • Data Monitoring Team Management of laboratory • Biorep Central Laboratory (Milan) with samples oversight from CC Quality assurance • Central Coordination and Professor Julie Stout’s team (with the support of EHDN) Role Responsibility Project management and • Study coordination team planning • Steering committee Regulatory documents (IRB) • Study coordination team Conducting investigator • Study coordination team meetings Conducting study expert • Study coordination team meetings Training of personnel • Centrally coordinated (EHDN/Julie Stout) motor and cognitive rater assessments Site identification and • High Q selection • Study coordination team Initiation visits • Study coordination team Monitoring visits • EHDN database manager • Direct on-line data monitoring Management of laboratory • Biorep/Coriell samples Quality assurance • HDNI (with imaging CRO) • EuroHD • Biorep/Coriell • Cognitive (Julie Stout and colleagues)
  • 6. PURPOSE OF THIS POST The Clinical Trial Project Manager will be responsible for the Track-HD central coordination team under the supervision of Dr Sarah Tabrizi, working closely with her and the other organisations involved, ensuring the successful delivery of the TRACK-HD study on a day-to-day basis. The Clinical Trial Project Manager will be responsible for ensuring that the study delivers high quality data, on time and within budget whilst maintaining the safety of subjects and the scientific goals of the study. RESPONSIBILITIES The key responsibilities are outlined in detail below. They involve the implementation and ongoing management of this large-scale multi-centre study: 1. Project Planning (planning and implementation of the study across all sites) 1.1. Coordinating protocol changes, including liaising with relevant contributors, amending documents, circulating revisions, ensuring that everyone is kept up to date. Protocol amendments may also involve coordinating changes to the budget with the Sponsor. There will be close working relationships between colleagues in at CHDI and Central Coordination. 1.2. Identifying and implementing study operating procedures (in conjunction with the quality assurance team at Monash University) 1.3. Coordinating clinical site personnel training in TRACK-HD assessments in conjunction with the clinical assessment experts (Key Opinion Leaders), ensuring that all personnel at all sites have received relevant training in time 1.4. Assisting the individual site PIs in obtaining local ethics and regulatory approvals for any amendments all sites 2. Project Management (day-to-day running of the study) 2.1. Overseeing implementation of the study protocol by clinical sites (in conjunction with on-site monitors); this may involve travelling to sites to discuss key study issues or to present updates 2.2. Identifying and managing risk to ensure that timelines are met and quality maintained 2.3. Defining recruitment plan for subject recruitment and stratification considerations (in conjunction with statistician). Following up on issues with sites and devises remedial action plans. 2.4. Coordinating regular progress and quality review meetings/teleconferences between Central Coordination and clinical sites, CROs and Key Opinion Leaders 2.5. Overseeing financial aspects of the study, including keeping track of spending and preparing budget and progress reports for the sponsor. In conjunction with the Sponsor and UCL the Clinical Trial Project Manager will manage a budget of approximately £6 million
  • 7. 2.6. Generating regular (6 monthly) study progress reports to the Sponsor and keep the Global PI apprised on all aspects of the trial, including progress and areas of concern 2.7. Ensuring that data are transferred on time and according to standard procedures 2.8. Coordinating processes for data analysis in conjunction with the study statisticians and Key Opinion Leaders 3. Scientific Management (securing the objectives and quality of the trial) 3.1. Ensuring quality is maintained by identifying procedures for quality assurance and the quality control of data, data scoring, data storage and analysis. Ensure that the relevant sites and CROs are trained and following such processes. 3.2. Defining an audit plan for the study (in conjunction with the Quality Assurance team at Monash University) 3.3. Assisting the Global PI by addressing (or referring where appropriate) monitoring queries related to subject eligibility and safety, and protocol deviations or violations 3.4. Contributing to decisions concerning protocol amendments, data analysis and publication plans 3.5. Planning, coordinating (and where required chairing) Steering Committee Meetings in conjunction with the Global PI 3.6. Providing technical/scientific input where required to contracts. Consulting on aspects of the contract which might affect strategy and Global PI/Key Opinion Leader interests. 3.7. Assisting in the preparation of conference abstracts and papers for submission to peer reviewed journals 3.8. Keeping up-to-date with current work in the field, by reading literature and attending relevant conferences and meetings 4. Line Management 4.1. Line management responsibility for the Clinical Trial Research Assistant (CTRA), who will assist in the smooth running of the study; this will include responsibility for planning and prioritising the CTRA, his or her staff development, approving annual leave and dealing with all line-management issues. 5. Patient Care 5.1. Acting at all times in accordance with the highest professional standards, and ensuring that these are maintained in the delivery of all aspects of research and patient care 5.2. Ensuring the strict confidentiality of all patient records
  • 8. 6. General 6.1. As duties and responsibilities change, the job description will be reviewed and amended in consultation with the postholder 6.2. The postholder will carry out any other duties as are within the scope, spirit and purpose of the job as requested by the line manager 6.3. The postholder will actively follow UCL policies including Equal Opportunities policies 6.4. The postholder will maintain an awareness and observation of Fire and Health & Safety Regulations. Person Specification Essential Criteria  Proven strong scientific academic background (PhD or equivalent experience)  Previous experience of clinical trial project management, including demonstrated management of complex research projects with a full knowledge of multi-country regulatory and ethics procedures  Proven leadership experience  Excellent inter-personal skills with an ability to work co-operatively in a multidisciplinary setting, in particular, liaison with a wide range of people including other study sites, sponsors, professional bodies etc  Excellent PC skills (Excel, Access, Word, Email, Internet, Powerpoint)  Meticulous and accurate in all aspects of work  Able to work under pressure and meet deadlines  Resourceful and able to act on own initiative  Excellent oral and written presentation skills  Willing to travel to Europe, Canada and the USA occasionally  Knowledge of ICH Good Clinical Practice and Clinical Research Governance  A very high level of consideration and care for patients and research subjects  Interested in research and a commitment to quality in the research process Desirable Criteria  Natural science background  Previous experience in an HD setting Appointment The post is available from July 2008 and is funded for one year in the first instance, renewable on an annual basis for a total of three years. It will be offered subject to satisfactory references, health clearance by the Occupational Health Department, and satisfactory completion of a nine- month probationary period. Salary on the UCL Grade 9 scale £45,397 - £49,606 pa plus £2,649 pa London Allowance, and market supplement, up to a total salary package of £60,000 pa. The post is superannuable under
  • 9. the Universities’ Superannuation Scheme (USS), or, subject to eligibility requirements, the National Health Service Superannuation Scheme (NHSSS). Annual Leave: 33 days Hours of Work: 36.5 hours Applications (full CV plus names of three referees and copy of the declaration below) should be sent (posted, faxed or emailed) to: Miss E Bertram Assistant Secretary (Personnel) Institute of Neurology Queen Square London WC1N 3BG Fax: +44 20 7278 5616 Email: personnel@ion.ucl.ac.uk Informal enquiries welcome to Dr Sarah Tabrizi (email: s.tabrizi@prion.ucl.ac.uk). Interviews will be held on Tuesday, 15 July 2008. Please note: Where applicants are short-listed for formal interview, references will normally be taken up prior to interview. Applicants who do not wish any referees to be so contacted should make this explicitly clear beside the referees’ contact details. We are unfortunately unable to reply to those applicants who have not been shortlisted and invited for interview. However, we would like to thank all candidates for their applications and for their interest in the Institute of Neurology. Please contact us on 020 7676 2191 if you wish to check the progress of your individual application.
  • 10. UCL To be completed by all those submitting a CV in application for a post with UCL. Our equal opportunities policy includes the provision that in recruitment, the only consideration must be that the individual meets or is likely to meet the genuine requirements of the job. No one will be discriminated against on the basis of gender, age, race, colour, ethnic origin, physical disability, marital status, sexual orientation, caring or parental responsibilities, or belief on any matters including religion and politics. Please complete this form in black ink/biro or by typing or an audio cassette. Application for the position of: Department: Institute of Neurology Ref No or Job Code: Surname: Title: Other Name(s): Preferred Forename: Address: Telephone numbers and email address at which we may contact you Work tel: Home tel: Email: Do you require permission/a work permit to take up employment in the UK? Yes/No (Immigration and Asylum Act 1996 – see attached sheet) I confirm that I will provide the relevant documentation should I be invited to interview. Do you need to register under the Home Office EU Accession State Worker Registration Scheme? (For further information, see: http://www.workingintheuk.gov.uk/working_in_the_uk/en/homepage/schemes_and_programmes/ worker_registration.html) Yes/No Have you ever been convicted in a Court of Law? Yes/No (Declaration subject to the Rehabilitation of Offenders Act 1974 and the (Exceptions) (Amendment) order 1986 – see attached sheet) If yes, please give details: How many days sick leave have you had in the last 12 months? Are you are 64 or over? Yes/No It is UCL policy that staff normally retire on the 31st July following their 65th birthday. In line with this UCL will not normally employ someone who is within six months of that date. (See http://www.ucl.ac.uk/hr/docs/retirement.php for more information) Do you have a Personal Relationship with any member of staff/student at UCL? Yes/No (See http://www.ucl.ac.uk/hr/docs/personal_relationships.php for more details) If so, please give details: To the best of my knowledge the answers given to the questions contained above and all statements made are true and accurate. I understand that any falsification may be considered sufficient cause for rejection or, if employed, dismissal. I give my consent to UCL to process sensitive data for the purposes of personnel administration. My consent is conditional upon UCL complying with the obligations and duties under the Data Protection Act 1998. Signature of applicant: Date:
  • 11. IMMIGRATION AND ASYLUM ACT 1996 Under Section 8 of the Asylum and Immigration Act 1996 it is a criminal offence to employ someone who does not have permission to be in, or to work in, the United Kingdom. The Act does provide a defence against a potential charge of employing an illegal worker if we can show that the person produced an "official document" when they commenced employment. You are asked to provide one of the following “official documents”. 1.1 Official Documentation  Current P45  Passport from an EEA country or visa stamp showing permission to work (for further advice, contact Human Resources) • Birth certificate from an EEA country Please note that a National Insurance number does not automatically indicate that the individual is eligible to work, and is not sufficient evidence. 1.2 REHABILITATION OF OFFENDERS ACT 1974 The Rehabilitation of Offenders Act 1974 is intended to ensure that a person convicted of a criminal offence (whether in Great Britain or abroad), not involving a sentence of more than 2.5 years’ imprisonment who has not since re-offended for a specified period of time (a rehabilitation period) related to the severity of their sentence is treated as if the offence, conviction and sentence had never occurred. Sentences of more than 2.5 years put an individual concerned outside the scope of the Act. Such convictions can never therefore become spent. (Exceptions) (Amendment) order 1986 Exempted professions NOT covered by The Rehabilitation of Offenders Act 1974 are:- • Medical practitioner • Barrister (in England and Wales), advocate (in Scotland), solicitor • Chartered accountant, certified accountant • Dentist, dental hygienist, dental auxiliary • Veterinary surgeon • Nurse, midwife • Ophthalmic optician, dispensing optician • Pharmaceutical chemist • Registered teacher (in Scotland) • Any profession to which the Professions Supplementary to Medicine Act 1960 applies and which is undertaken following registration under the Act.
  • 12. CONFIDENTIAL STAFF EQUAL OPPORTUNITIES CLASSIFICATION FORM Surname:       First Name(s):       Date of Birth:       Department:       University College London has a commitment to ensuring that staff are appointed and promoted on the basis of merit, regardless of ethnic origin, sex or disability, sexual orientation, race, colour, nationality (within current legislation), marital status, caring or parental responsibilities, age, or beliefs on matters such as religion and politics. Monitoring enables us to see what is happening in practice, to assess the impact of our equal opportunities policy and its implementation, and to set any targets for improvements, and measure progress. To enable us to do this, and to make the exercise successful, we rely on all staff to supply the following details, which will be treated in the strictest confidence. Thank you for your co-operation. Choose the appropriate box Ethnic Group White – British White – Irish White – Other Mixed Race - White & Black Caribbean Mixed Race - White & Black African Mixed Race - White & Asian Mixed Race - Other Asian/Asian British-Indian Asian/Asian British-Pakistani Asian/Asian British-Bangladeshi Asian/Asian British-Other Black/Black British-Caribbean Black/Black British-African Black/Black British-Other Chinese Any Other Information refused Sex Male Female Nationality       Are you disabled or do you have any condition that may require adjustments to your work or working environment? (Examples of a ‘condition’ may include impairment of senses, co-ordination, memory, mobility, learning, health or wellbeing.) Yes No (If you have ticked yes, you will be contacted by UCL’s Occupational Health Service to assess your requirements and to advise your manager of any reasonable adjustments that are needed) I do consider myself to have a disability, but I do not wish this information to be shared with anyone else. Yes No
  • 13. (If you have ticked yes, but require reasonable adjustments in the future, it is your responsibility to inform UCL through your manager)