Cancer Clinical Trials Department. Clinical Research Nurse - Haematology. Clinical Nurse Manager 1 grade. Specified Purpose Contract

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1 BEAUMONT HOSPITAL Beaumont Hospital incorporating St. Joseph's Hospital, Raheny is a major teaching hospital providing an important Emergency Medicine and Trauma service together with National and Regional services in a number of specialties. The hospital is one of the eight designated centres for the development of cancer services in Ireland. The hospital employs approximately 3,000 staff and has a complement of 820 beds. Applications are invited for the following post: Cancer Clinical Trials Department Clinical Research Nurse - Haematology Clinical Nurse Manager 1 grade Specified Purpose Contract Requirements: Be registered in the relevant division of the Register of Nurses kept by An Bord Altranais or be entitled to be so registered and Have at least 3 years post registration experience of which 1 must be in the speciality or related area and Have the clinical, managerial and administrative capacity to properly discharge the functions of the role. Desirable Criteria: Have either a postgraduate qualification in Oncology/Haematology or previous experience as a clinical trials research nurse ICH GCP certification Clinical Trial experience Informal enquiries to Derval Kehily, Clinical Trials Manager by telephoning or dervalkehily@beaumont.ie Should a large number of applications be received the hospital will shortlist based on the required qualification for the post as outlined above and the desirable criteria. If you are interested in the above post please forward detailed curriculum vitae (5 copies, unbound) together with the names and addresses of two referees, one of whom should refer to a current employer, to the: Recruitment Section, Human Resources Department, Beaumont Hospital, Beaumont Road, Dublin 9. Please outline clearly which post (s) you are applying for. Closing date for receipt of applications is 5.00 p.m. on Tuesday, 22nd March, A panel may be formed from which vacancies that may arise over the next 12 months may be filled. Visit our website: or Beaumont Hospital is an equal opportunities employer

2 Beaumont Hospital Cancer Clinical Trials and Research unit Post Title: Clinical Research Nurse CNM 1 Post Grade: CNM 1 Department/Faculty: Haematology Beaumont Hospital Cancer Clinical Trials & Research Unit Hours: 39 hours per week. (Normally within the hours of to Monday to Friday as agreed - This role may require flexibility on occasion). Reporting to: Programme Manager Responsible to: Consultant Haematologists / Principal Investigators and the CCTU Medical Director Professionally Accountable to: ADON Medical Oncology / Haematology Directorate Location: Beaumont Hospital Summary of Job The Cancer Clinical Trials & Research Unit (CCTU) is based at Beaumont Hospital, Beaumont Road, Dublin 9. It is led by a Medical Director (CCTU Lead) and managed on a day to day basis by the Programme Manager. The Clinical Research Nurse (CRN) is required to manage, coordinate and implement assigned clinical research studies which will be conducted through the CCTU. The appointee will liaise with the research team to provide trial protocol education and to ensure recruitment targets are met, informed consent is obtained and to ensure accurate data collection.. The mission of clinical research nurses in the CCTU is to support the practice and development of the cancer clinical research programme for Beaumont Hospital and its affiliated institutions across Dublin North East (RCSI Hospital Group); provide specialised nursing care to patients in clinical research and their families, knowledgeable management of the clinical research protocol, effective communication, and staff education, working within a team to achieve high standards in patient care and clinical outcomes. BACKGROUND INFORMATION The CCTU is funded, in part, by grant funding from the Health Research Board (HRB) and through pharmaceutical support for clinical trials managed through the Beaumont Hospital Cancer Clinical Trials & Research Unit. The team of Clinical Research Nurses, under the direction of the CCTU Medical Director and the day to day management of the Programme Manager, work closely with

3 Haematologists, Oncologists, Clinical Data Managers, Pharmacists, Administrative Assistant, and the broader Multi-disciplinary Team. This post is funded by the Irish Cancer Society. The Irish Cancer Society The Irish Cancer Society s mission as the national cancer charity is to eliminate cancer. To achieve this, one of the Society s goals is to lead excellent, collaborative research in Ireland. The Society believes that the quality of cancer care available in Ireland depends on the quality of cancer research taking place in the country and that collaboration between scientists and clinicians is essential to driving improved medical care and better outcomes for patients. Irish Cancer Society, along with Science Foundation Ireland (SFI) is investing substantially in Blood Cancer Network Ireland (BCNI) and hopes to make novel drugs and treatments available to blood cancer patients throughout the country over the next five years. Blood Cancer Network, Ireland BCNI will be established nationwide through clinical research facilities in St James's Hospital and Trinity College Dublin, University College Cork and NUI Galway. The Irish Clinical Oncology Research Group (ICORG) will also be a partner in this national network. The newly established Blood Cancer Network Ireland (BCNI) is a virtual clinical research network that will make early-stage haematology clinical trials available - in other words, it will allow Irish patients to take part in trials for new drugs and treatments. Part of the work of the new network will be to establish a blood cancer bio bank to collect and analyse patient samples to further scientists' knowledge and understanding of blood cancers. By supporting resources the ICS facilitates Beaumont Hospital Haematology Department collaboration with the newly established BCNI thereby ensuring patients across the Dublin, Dublin North East have access to novel treatments and improved care and outcomes through research.. Research responsibilities will include: Work within standard operating procedures and research protocols associated with industry and academic clinical research activities. Play an active role in driving ongoing clinical research projects. Actively participate in the implementation of clinical investigations and trials Assist in ensuring the overall successful completion of clinical research projects in line with best practice. Arrange study specific research meetings if necessary, including staff notification, completion and writing of minutes where applicable. Ensure patient confidentiality and dignity is assured and maintained at all times during a clinical trial/research project. Take responsibility for maintenance and upkeep clinical research documentation, including: site files, case record forms, monitoring arrangements, data correction and data collection.

4 Prepare ethical submissions &, query resolution as required for assigned research projects, working closely with BCNI research team to support collaborative projects Review proposed research protocols and provide input to site study feasibility reports (e.g. annual site patient numbers, equipment / test availability etc.). Provide study specific education and training to the broader research team eg the Haematology and / or Oncology nurses, NCHD s as required Attend investigator meetings as appropriate relative to studies assigned to you. Ensure prompt management of all study related correspondence. Prepare your studies for Internal / Sponsor / Health Products Regulatory Authority (HPRA) audits as required. Ensure that patients are fully informed of all details pertaining to the clinical trial/research project prior to their recruitment. Screen patients in order to identify suitable study candidates. Ensure that all assigned studies are completed to the highest standards in accordance with ICH-GCP, HPRA/EU Directive requirements. Prepare study reports and other reports eg, research activity for ICS as required from time to time by Dr Quinn. Carry out other duties as appropriate to the post as may be assigned from time to time by the Principal Investigator and / or Programme Manager. Clinical Practice responsibilities will include: Provide nursing knowledge, expertise and care to patients participating in a clinical trial. Ensure patients have an understanding of their disease and the proposed research and standard treatment options. Work with a Multidisciplinary Team in evaluating and treating clinical problems, as they arise in the research settings. Utilising technology to download and interpret electronic clinical data during patient visits Be competent in phlebotomy procedures or be willing to train. Adhere to nursing policies for Beaumont Hospital. Ensure continuity of patient care by liaising with outside health care professionals, and those who are involved in clinical work as appropriate. Use agreed procedures to deal with referrals and enquiries from other hospitals Promote a safe environment for patients, visitors and staff with due regard to Health and Safety and Risk Management issues. Professional development Maintain professional registration. Undertake further education as appropriate to keep updated with changes within the field of Clinical Research. Attend and participate in: In service and staff education Staff Conferences Appropriate outside conferences and/or other professional development activities. Identify nursing research opportunities Take responsibility for own professional development and skills updating including maintaining a record of activities in a training folder.

5 Quality Assurance Develop good lines of communication with the Principal Investigator and other key research/clinical stakeholders to ensure full awareness of the progress of designated research studies and to identify issues of concern early. Help maintain the systems for recording clinical activity. Demonstrate commitment to evidence based practice. Maintain clinical and administrative records and reporting arrangements. Provide a high quality efficient and effective service, respecting the needs of each patient. Continually monitor the service ensuring it reflects current needs and implement change where required. Carry out all activities within the currently applicable Standard Operating Procedures of the CCTU and assigned research studies. General Hours of work: Normal working hours are 39 worked over 5 days but the appointee will attend at such other times as are required for the proper discharge of the duties of the office. This may require attendance outside normal working hours.. Annual Leave: Annual leave entitlement is as per Department of Health / INO standards. The annual leave year runs from 1st January to 30 th December each year.