JOB DESCRIPTION Post Title: Clinical Research Nurse Institute: National Heart and Lung Institute Division/Section: International Centre for Circulatory Health Job Family and Level: Agenda for Change, Band 6 Salary Range: £25,783 – £34,530 per annum plus Inner London Allowance (20% of basic salary, minimum payment of £4,076 and maximum to £6,279) Responsible To: Professor Darrel Francis, Professor of Cardiology Works closely with: Emma Coady, Senior Clinical Studies Coordinator Working Relationships: Research fellows, clinical research nurses and support staff Contract: Full-time and fixed-term for 12 months Location: St Mary’s Campus Job Summary You will join an established team of Clinical Research Nurses, Cardiac Physiologists and project support staff working on a portfolio of studies within the ‘Mechanisms of Disease’ (MoD) group at Imperial College London. You will work on three main studies but will be expected to contribute to the portfolio of studies. The REACH study is investigating the impact of renal denervation on symptomatology, chemoreflex, baroreflex cardiopulmonary exercise physiology and cardiac performance in patients with chronic heart failure compared with sham procedure. This study is in the recruitment phase and along with the Senior Clinical Research Nurse you will be involved in developing effective recruitment strategies and coordinating investigations, collecting and documenting accurate data, ensuring adherence to study protocol and that quality control measures are in place. The SURESCAN study is an EU funded programme of research to develop bed-side ultrasound quantification techniques. Your role will be to recruit participants and be involved in the acquisition of data. The BRAVO study is a randomised clinical trial of the effects of non-invasive haemodynamic optimisation of cardiac resynchronisation devices on exercise capacity. This study is nearing the end of the recruitment phase and is near to reaching the target of 400 participants. You will be responsible for maintaining the follow-up phase of this study and will work alongside an established team of cardiac physiologists in coordinating the follow-up visits throughout 2014. 1 The role involves using an in-depth knowledge of study protocols and their application in practice, alongside a working knowledge and compliance with the local, national and international research regulations. Along with the Senior Clinical Studies Coordinator and other team members you will be expected to collaborate and develop strong links with a number of study stakeholders (e.g. Principal Investigators, co-investigators, clinicians, and cardiac technicians) in the management of your own caseload of research participants. The majority of the work will be at the St. Mary’s Campus but you may be required to travel to other research sites. Key responsibilities Research To maintain the clinical management of the MoD studies and manage timescales and resources to ensure delivery of the protocol to agreed timetables. To liaise closely with the Senior Clinical Studies Coordinator and report to the study Principal Investigator regarding the conduct and progress of the study. To ensure regulatory approvals (NHS Research & Development, Medicines and Healthcare products Regulatory Agency (MHRA), Research Ethics Committee (REC) are in place prior to commencement of the study and are updated as appropriate. To be responsible for monitoring and supervision of studies to ensure the study protocol is adhered to by the research team. To work with relevant NHS trusts, general practices, clinicians and NHS managers to raise awareness and encourage participation in the MoD studies To ensure that all study personnel work according to International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) and research governance standards. To facilitate the informed consent process in accordance with GCP and REC guidelines. To work with the database manager to ensure the study database incorporates appropriate user requirements. To liaise with personnel outside the NHS trusts, and Imperial College London as necessary to assist the research process. To supply accrual data as required to the relevant Clinical Research Network. To identify barriers to recruitment to the study, develop and support action plans as required and ensure that the Chief Investigator is aware of them To arrange and encourage participation in study progress meetings for coinvestigators, collaborators, participating PCTs and other study personnel. Management To line manage nursing and non-nursing staff within the clinical environment. To ensure the appropriate use of the staff and non staff budget and be aware of the resource implications of clinical and managerial decisions. To initiate and review clinical guidelines and standard operating procedures in order to maintain high standards of care as defined by ICH GCP. To ensure staff are aware of the protocols and progress of all studies. 2 Leadership To maintain the research participants’ involvement in the study and elicit their views and opinions to develop the portfolio of studies. To act as a role model regarding research within Imperial College London and Imperial College Healthcare Trust. To proactively recognise and respond to factors which impinge upon staff morale and standards of care. To be able to organise own workload in accordance with other demands To make other members of staff aware of current research and studies ongoing in ICCH, Imperial College London and Imperial College Healthcare NHS Trust. To contribute to regular team meetings and ensure that information is communicated throughout the teams. Clinical To manage a caseload of research participants visits alongside other clinical responsibilities. To co-ordinate the clinical and off-site caseload of the portfolio of studies providing cover where necessary. To undertake training in diagnostic exercise physiology testing and other clinical assessments. To be involved in all aspects of the REACH, BRAVO and SURESCAN studies and identify areas for development and improvement. To ensure study physician cover is negotiated and available for each study where appropriate. To audit the completion of case report forms (CRF). To maintain systems which store and back up study data appropriately. To ensure staff are trained in blood sample processing, storage and movements tracked as required by the study protocol and according to trust protocols. To ensure quality control measures are in place for each clinical investigation. To provide research participants with a primary point of contact for queries, questions or support. Professional and Educational Responsibilities To participate in, and contribute to, the academic programme of seminars and staff meetings in the locality. To act as a resource for colleagues in relation to all aspects of clinical research. To assist in the education and support of health care professionals to enable them to care for research participants. To maintain an up-to-date knowledge of cardiovascular research related articles. To ensure new staff are effectively orientated to the team and receive ongoing support and education. Continue your own professional development keeping up-to-date with current practice and maintaining Post-registration education and practice requirements. To maintain links with other research nurses and clinical nurse specialists within Imperial College Healthcare NHS Trust to share knowledge and provide mutual support. 3 To develop personal and professional knowledge through study, critical selfappraisal, clinical supervision and networking with other health professionals locally and nationally. Other To ensure that the views of research participants are effectively sought, channelled and acted upon. To act in accordance with the Nursing and Midwifery Council Code of Professional Conduct. To maintain patient confidentiality at all times. To observe and comply with all College policies and regulations, including the key policies and procedures on Confidentiality, Conflict of Interest, Data Protection, Equal Opportunities, Financial Regulations, Health and Safety, Imperial Expectations (for new leaders, managers and supervisors), Information Technology, Private Engagements and Register of Interests, and Smoking. To undertake specific safety responsibilities relevant to individual roles, as set out on the College Website Health and Safety Structure and Responsibilities page (http://www3.imperial.ac.uk/safety/policies/organisationandarrangements). Job descriptions cannot be exhaustive and the post-holder may be required to undertake other duties, which are broadly in line with the above key responsibilities. Imperial College is committed to equality of opportunity and to eliminating discrimination. All employees are expected to adhere to the principles set out in its Equal Opportunities in Employment Policy, Promoting Race Equality Policy and all other relevant guidance/practice frameworks. 4 IMPERIAL COLLEGE LONDON PERSON SPECIFICATION Qualifications: Essential: Registered Nurse To have or be willing to undertake further professional qualifications Knowledge and Experience: Essential: Experience working in a relevant clinical speciality Experience of using research methodologies Knowledge and/or experience of clinical trials/research Experience of managing patient caseload Knowledge of research governance Awareness of resources and the ability to operate within a financial budget Desirable: A sound knowledge of and experience in cardiovascular nursing Previous management or teaching experience Experience of patient recruitment in primary care A knowledge of Good Clinical Practice (GCP) in the context of clinical trials Experience of change management Experience of clinical supervision Experience of audit and quality initiatives Skills and Abilities: Essential: Excellent clinical skills including competence in venepuncture Ability to work effectively and independently as well as part of the multidisciplinary team Ability to prioritise, instruct, direct and motivate others Good organisational and managerial skills Excellent communication skills with the ability to communicate at all levels Computer literate The ability to manage conflict Methodical and accurate in the gathering and recording of data Ability to show evidence of continuing professional development relevant to the speciality Ability to show evidence of teaching and mentoring Ability to accommodate a flexible work pattern to achieve the study requirements Other: A strong sense of vision for developing the role 5