NIHR CRN: North Thames Research Administration Coordinator

Transcription

1 JOB DSCRIPTION NIHR CRN: North Thames Research Administration Coordinator GOSH profile Great Ormond Street Hospital for Children NHS Foundation Trust (GOSH) is a national centre of excellence in the provision of specialist children's health care, currently delivering the widest range of specialist care of any children's hospital in the UK. It is the only specialist Biomedical Research Centre for paediatrics, the largest centre in the UK for children with heart or brain problems, and the largest centre in urope for children with cancer. It works in partnership with the UCL Institute of Child Health (ICH), part of University College London, and together they form the largest paediatric research and teaching centre in the UK. The hospital at Great Ormond Street is the only exclusively specialist children's hospital in the UK. It does not have an Accident and mergency department and only accepts specialist referrals from other hospitals and community services. The population of children served by the hospital is characterised by those with multiple disabilities and/or health problems and rare and congenital (present at birth) conditions. Many children need the help of different specialist teams. Improvements in health care and diagnosis mean that many children have dramatically improved survival rates and more therapeutic options than was the case 10 years ago. Sadly though, many of the children cared for at GOSH still have life threatening or life-limiting conditions. The hospital receives over 255,000 patient visits (inpatient admissions or outpatient appointments) a year, and carries our approximately 18,800 operations each year. The hospital has 383 patient beds, including 44 intensive care beds (21 CICU, 15 PICU and 8 NICU). Many of the children and young people on our wards require high dependency care or are classed as ward intensive care, requiring one-to-one nursing. Around 4,100 full-time and part-time staff work at the hospital. The ICH has around 600 staff. Many senior staff have roles in both organisations. The hospital has approximately 50 paediatric specialties, the widest range of any hospital in the UK, which uniquely enables it to diagnose and pioneer treatments for children with highly complex, rare or multiple conditions. It has 19 highly specialised national services.

2 Job title Division Research Administration Coordinator Local Clinical Research Network (Research and Innovation) Band 5 Responsible to Accountable to Type of contract Industry Operations Manager Deputy COO Fixed term Hours per week 37.5 Location Budgetary responsibility Manages Tottenham Court Road, London Nil Nil Trust Values and xpected Behaviours Over 2,000 of our staff, patients and parents have developed a set of Values Our Always Values. These are the values that should characterise all that we do and our behaviours with our patients and families and each other. Our Always Values are that we are: Always Welcoming Always Helpful Always xpert Always One Team These values are extremely important to us and we expect everyone who works at GOSH in any capacity, including employees, bank staff, contractors, agency staff, people who hold honorary contracts, students and volunteers to share and uphold Our Always Values. ach value is underpinned by behavioural standards and employees will be expected to display these behaviours at all times. You can find a full copy of Our Always Values on our intranet. The Trust also expects that everyone who works here shall act in such a manner as to justify public trust and confidence and to uphold and enhance the good standing and reputation of Great Ormond Street Hospital for Children NHS Foundation Trust. Individuals must therefore at all times carry out their duties with due regard to the Trust s quality at Work Policy. National Context The National Institute for Health Research (NIHR) is funded through the Department of Health to improve the health and wealth of the nation through research. The NIHR is a large, multi-faceted and nationally distributed organisation. Since its establishment in April 2006, the NIHR has transformed research in the NHS. It has increased the volume of applied health research for the benefit of patients and the public, driven faster

3 translation of basic science discoveries into tangible benefits for patients and the economy, and developed and supported the people who conduct and contribute to applied health research. The NIHR Clinical Research Network (NIHR CRN) is the clinical research delivery arm of the NHS in ngland, tasked with supporting the rapid set-up and effective conduct of studies, so that researchers can gather the robust evidence needed to improve treatments for NHS patients. The NIHR Clinical Research Network is led by a national Coordinating Centre (NIHR CRN CC), and operates through 15 Local Clinical Research Networks (LCRNs). These local Networks drive clinical research delivery performance across the locality, and champion the role of clinical research in the NHS at every level. Local Context Barts Health NHS Trust, as part of UCL Partners Academic Health Science Network, is the Host organisation for the North Thames Clinical Research Network (NIHR CRN: North Thames) comprising 23 member NHS Trusts: BARKING, HAVRING AND RDBRIDG UNIVRSITY HOSPITALS NHS TRUST BARNT, NFILD AND HARINGY MNTAL HALTH NHS TRUST BARTS HALTH NHS TRUST BASILDON AND THURROCK UNIVRSITY HOSPITALS NHS FOUNDATION TRUST CAMDN AND ISLINGTON NHS FOUNDATION TRUST AST LONDON NHS FOUNDATION TRUST GRAT ORMOND STRT HOSPITAL FOR CHILDRN NHS FOUNDATION TRUST HRTFORDSHIR COMMUNITY NHS TRUST HOMRTON UNIVRSITY HOSPITAL NHS FOUNDATION TRUST LUTON AND DUNSTABL HOSPITAL NHS FOUNDATION TRUST MID SSX HOSPITAL SRVICS NHS TRUST MOORFILDS Y HOSPITAL NHS FOUNDATION TRUST NORTH AST LONDON NHS FOUNDATION TRUST NORTH MIDDLSX UNIVRSITY HOSPITAL NHS TRUST ROYAL FR LONDON NHS FOUNDATION TRUST ROYAL NATIONAL ORTHOPADIC HOSPITAL NHS TRUST SOUTH SSX PARTNRSHIP UNIVRSITY NHS FOUNDATION TRUST SOUTHND UNIVRSITY HOSPITAL NHS FOUNDATION TRUST TAVISTOCK AND PORTMAN NHS FOUNDATION TRUST TH PRINCSS ALXANDRA HOSPITAL NHS TRUST TH WHITTINGTON HOSPITAL NHS TRUST UNIVRSITY COLLG LONDON HOSPITALS NHS FOUNDATION TRUST WST HRTFORDSHIR HOSPITALS NHS TRUST

4 Cheif Operating Officer Organogram This position(s) circled Costing and Contracts Team Head of Finance and Information Information Team Deputy Cheif Operating Officer Study Support Service Lead Research Support Manager Pharmacy/Medical xposure Review Manager Research Admin Coordinator(s) Support Service Coordinator Industry Operations Manager Industry Officer Research Admin Coordinator Research Delivery Manager(s) Deputy Research Delivery Manager(s) Portfolio Officer(s) Scope of the role To provide comprehensive administrative support service to the core functions of the LCRN as well as senior members of the divisional teams. Activities will include active management of aspects of the local performance management system (DG), and the supporting the Industry team in processing commercial related correspondence e.g. expressions of Interest. Improved communications between the divisions and core teams of the LCRN, ensuring urgent matters are prioritized and delays are not allowed to occur. Improved responsiveness to requests for assistance from NIHR Coordinating center, researchers, stakeholders and divisional research teams. Key working relationships Internal: - Clinical Director, Chief Operating Officer and Deputy Chief Operating Officer - Industry Operations Manager - Study Support Service Lead - Head of Finance and Information - Research Delivery Managers and Deputy Research Delivery Managers

5 - Portfolio Officers - Pharmacy and M review team - Information Team - Costings and Contracts Team - Clinical Research Leads - Clinical Research Specialty Leads xternal: - Clinical and or Academic researchers - Staff within the Host Trust - NIHR Clinical Research Network Coordinating Centre (NIHR CRN CC) staff - Commercial and non-commercial sponsor contacts - Clinical trials units/research Facility staff - Study Coordinators - Divisional Staff working within Member Organisations - R&D Staff within the LCRN in Member Organisations - Other LCRN staff - Finance, R&D and HR managers in member organisations Main duties and responsibilities 1. Professional Responsibilities Skilled in communicating with a range of people on a daily basis some of who may have communication barriers. Takes a proactive role in producing accurate and complete records of activities and communications consistent with legislation, protocols, policies and procedures 2. Research management and Study Support Input study data in the correct format and manner on to relevant systems including the Local Portfolio Management System (DG) Maintain the integrity of research information using agreed methods and procedures. To provide researchers and Partner Organisations a supportive and facilitative environment for the research support in line with national NIHR, DH and HRA processes. To support Partner Organisations so they comply to National agreed times frames for research support.g. document set validation To support Partner Organisations to ensure that NIHR Processes are understood and adhered to.

6 To support and trouble shot any queries from NIHR Coordinating Centre, Partner Organisations or Local researchers. To support CI/ Research Teams with their research package and submissions To track projects progression within national and local IT Systems eg ODP, CPMS, LPMS and Partner Organisations so they are able to meet NIHR CRN High Level Objectives (HLOs) To ensure that study records are kept up-to-date in both local and national databases, identify discrepancies and correct when appropriate Monitoring Study Support Service and Industry generic inboxes- acting as primary point of contact for general enquires Manage and update the North Thames RM&G and Industry distribution mailing list Supporting the portfolio officers and dep Research Delivery Managers complete the aspects of study set up and feasibility To bring to the attention of the Assistant research delivery Manager Officer when national processes, quality of reviews or times frames may not have been followed Work closely with the Pharmacy/Imaging/Pathology Review manager to ensure local support feasibility/assessment is managed within the applicable timeframes Assist with the distribution and collation of expressions of interest for new studies and the feasibility assessment process. To provide regulatory advice to researchers, sponsors and other colleagues within the Network To maintain a strong and current working knowledge of developments regarding clinical research management, regulation and governance. 3. Industry Work closely with the Industry Operations manager to distribute commercial related tasks Maintain an effective monitoring system to ensure tasks are completed in line with pre-defined deadlines Liaise with national coordinating centre(s) on collation of industry related activity/information/metrics Work closely with divisional portfolio officers, dep Research Delivery Managers and Research Delivery Managers to ensure effective and coherent information management. 4. ducational and Professional Development xercises professional accountability and responsibility in changing environments across professional boundaries. Proactive in ongoing training and development by identifying personal and education needs which are essential for fulfilling the role to maximum effect and with a view to making a contribution to the development of research within the LCRN. 5. Risk and Governance Management The post holder is required to familiarise him/herself with and comply with the Trust s policies and procedures. The post holder must at all times ensure that GCP guidelines and regulatory and ethical requirements are maintained and that Research Governance Standards are adhered to. Working closely with the Research and Development office and Trust to ensure that all clinical trials undertaken within the Network are accurately costed, indemnified and registered and comply with GCP Standards.

7 The post holder must at all times respect patient confidentiality and in particular the confidentiality of electronically stored personal data in line with the requirements of the Data Protection Act (1998). Monitors work areas and practices and ensures that they are safe and free from hazards, conform to health safety and security legislation, policies, procedures and IATA guidelines. This job description is intended as an outline of the areas of activity and can be amended in the light of the changing needs of the service and will be reviewed as necessary in conjunction with the post-holder. Other information Great Ormond Street Hospital for Children NHS Foundation Trust is a dynamic organisation, therefore changes in the core duties and responsibilities of this role may be required from time to time. These guidelines do not constitute a term or condition of employment. Confidentiality On appointment you may be given access to confidential information which must only be disclosed to parties entitled to receive it. Information obtained during the course of employment should not be used for any purpose other than that intended. Unauthorised disclosure of information is a disciplinary offence. Risk Management You will be required to ensure that you implement systems and procedures at a local level to fulfill the requirements of the organisation s Risk Management Strategy including local management and resolution of complaints and concerns, management of SUIs/incidents and near misses. Your specific responsibility for risk management will be clarified to you by your manager at your local induction. mergency Planning In accordance with the organisations responsibilities under the Civil Contingencies Act 2004, you may be required to undertake alternative duties as is reasonable directed at alternative locations in the event of and for the duration of a significant internal incident, major incident or flu pandemic. Human Rights You are required to comply with the regulations of the Human Rights Act 1998 during the course of your employment. Sustainable Development You will be required to demonstrate a personal commitment to the Trust s Sustainable Development Plan and to take personal responsibility for carrying-out your work duties in a way which is compliant with this Plan.

8 PRSON SPCIFICATION vidence for suitability in the role will be measured via a mixture of application form, testing and interview ssential: Desirable: D Our always values ducation, training and qualifications Always welcoming positive, polite, prompt, responsive Degree or equivalent level experience in a relevant subject (science, health related). Always helpful respectful, supportive, approachable; caring GCS (grade c or above) in nglish and Mathematics. Always expert Up-to-date knowledge, strive to provide a quality service, proactive Training in clinical research or related field. Always one team informative, mindful, appreciative, open, honest D GCP certification D D Skills and abilities Knowledge & xperience Ability to communicate clearly and effectively (written and verbal) with a wide range of people, and to build credibility quickly. Previous administrative experience, preferably within clinical research Mature and sound judgement, with ability to solve problems and apply rules firmly but with discretion. xperience of working in the NHS, University or commercial health research sector Ability to analyse and appraise complex information from multiple sources, and to reach accurate assessments. D xposure of working with the pharmaceutical industry Ability to use IT systems, with good working knowledge of Microsoft Office systems, and databases. D Understanding of Research Governance in the NHS.

9 D Clear and effective presentation skills, both oral and written. Understanding of medical/clinical terminology Methodical approach to work with good organisational skills. D Detailed operational knowledge of the rules, legislation, regulation and practical implications surrounding clinical research governance; including The Research Governance Framework, The U Directive on Clinical Trials (and resultant UK Statutory Instruments), UCH-GCP, The Data Protection Act, The Human Tissue Act, The Mental Capacity Act, The Health & Safety at Work (etc.) Act and other related requirements. Ability to build productive alliances and relationships. Initiative and drive to achieve results. Facilitative, patient and helpful. Attention to detail and conscientious. nthusiastic and self-motivated. Strives for quality and safety. Flexible and adaptable approach. Willingness to travel if required