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2 Contents Section Section 1: Section 2: Section 3: Section 4: Section 5: Section 6: Section 7: Section 8: Section 9: Introduction to Appointment Person Specification Job Description NHS Lothian Values General Information for Candidates Working in Edinburgh and the Lothians Workplace Equality Monitoring Equal Opportunities Policy Statement Code of Conduct for Healthcare Support Workers

3 Section 1: Introduction to Appointment Reference Number: WGH/ONC/17/B6/N68 Job Title: Breast Surgery Research Nurse Grade: Band 6 Location: Edinburgh Breast Unit, NHS Lothian Contract Duration: Fixed Term for 18 Months Hours: 22.5 hours per week Closing Date: 30 November 2017 Salary Scale: 26,830-35,933 pro rata per annum Apply on-line Please note the address you provide on the application form will be used to communicate any further correspondence relating to this vacancy therefore please check your TRASH and SPAM folders This post requires the post holder to have a PVG Scheme membership/ record. If the post holder is not a current PVG member for the required regulatory group (i.e. child and/or adult) then an application will need to be made to Disclosure Scotland and deemed satisfactory before they can begin in post. **Please note: we anticipate a high level of interest in this position and may close the vacancy early once a sufficient amount of applications are received. Therefore, please make sure you complete and submit your application at an early stage.**

4 Section 2: Person Specification NHS LOTHIAN Early Phase Research Nurse PERSON SPECIFICATION Criteria Essential Desirable Qualifications & Training Registered General Nurse Degree or working towards Degree in relevant subject Experience RGN with significant oncology and/or research experience Oncology Experience and Research Experience Knowledge Familiar with ICH GCP Working knowledge of ICH GCP Knowledge of the research Skills/Abilities Specific Job Requirements Environmental conditions, unsociable hours, car driver etc. Excellent communication skills Venepuncture Cannulation Ability to work independently Unsocial hours may be required in line with protocol requirements Trained in Cytotoxic Chemotherapy administration Signed: PRINT NAME: Designation: Date:

5 Section 3: Job Description NHS LOTHIAN UNIVERSITY HOSPITALS DIVISION RESEARCH NURSE GRADE JOB DESCRIPTION 1. JOB IDENTIFICATION Job Title: Cancer Research Nurse Band 6 Responsible to: Scottish Cancer Research Network Manager/ Clinical Director Breast Surgery Directorate: Cancer Service Operating Division: NHS Lothian University Hospitals Division Job Reference: WGH/ONC/17/B6/N68 No of Job Holders: 10 Last Update: 30/10/ JOB PURPOSE The post holder has professional and managerial responsibility for the implementation and delivery of trial clinics in breast disease within the Edinburgh Breast Unit. This will be within NHS Lothian, Western General Hospital. The Research Nurse has responsibility for follow up and care of Breast Cancer trial patients with support and direction from consultant breast surgeons. In addition, as a senior member of the research team, the post holder will have responsibility for the delivery of the highest standards of direct and indirect care and associated data collection for concurrent research studies undertaken in the breast cancer research team, in accordance with the International Conference on Harmonisation Good Clinical Practice Guidelines (ICH-GCP). This is done in partnership with all members of the multi disciplinary and research teams.

6 3. DIMENSIONS The post holder will work within Scottish Cancer Research Network (SCRN) within the breast team (as detailed in section 5). The post holder must also attend multidisciplinary meetings and clinics as a dedicated resource to provide expert advice on clinical trial activity. The nurse is responsible for delivering patient care and treatment in the outpatient ward setting, or liaising with other nursing staff to deliver the care as dictated by the study protocols, which may involve novel therapies and procedures. The post holder will attend study initiation visits and trial updates with dissemination of this information to the rest of the research team and staff. The role will provide expert nursing and research advice, mentoring and education for other research nurses, clinicians and staff members within the multidisciplinary team. The exact dimensions of the numbers and types of studies vary in accordance with the dynamic nature of the research programme. 4. ORGANISATIONAL POSITION Research Network Manager Senior Data Manager Breast Team 2 Breast Senior Research Nurse Senior Research Nurse/Lead Research Nurse Local Cancer Units Data Managers Research Nurses Team 2 Breast and Sarcoma Research Nurse This Post

7 5. ROLE OF DEPARTMENT The South East Scottish Cancer Research Network encompasses several partners involved in the delivery of cancer clinical trials to patients across South East Scotland, including: - 4 NHS Boards and 7 hospital sites across Lothian, Borders, Fife, Dumfries & Galloway - Cancer Research UK - South East Scotland Cancer Network (SCAN) and its 9 tumour-specific multi-disciplinary groups - Experimental Cancer Medicine Centre - University of Edinburgh researchers Approx 10,000 newly diagnosed cancer patients per year across SCRN-SE [ISD, 2015]. Approx new patients entered into cancer research per year in SCRN-SE region. Around 200 active clinical trials registered on SCRN-SE database providing trials for approx 18 different tumour types. Approx 60 clinicians, 40 nurses and 20 data managers actively involved in clinical trials across the Region. SESCRN is directed by the Clinical Lead and Research Network Manager, with the support of a Steering Group, and report directly to the Chief Scientists Office on use of resources, patient recruitment targets and overall objectives. SESCRN is divided into 8 teams, each team providing support for clinical trials in different tumour types as outlined below: Tea m Tumour Groupings 1 Phase 1, Gynaecology, Melanoma, Colorectal 2 Breast, Sarcoma, Haematology 3 Lung, Head & Neck, Brain 4 Urology, Upper GI, Hepatobiliary H BS P SK Haematology Breast Surgery Palliative Care Children s services (Sick Kids)

8 6. KEY RESULT AREAS Professional Leadership and Management 30% Conduct clinical research in accordance with ICH GCP Guidelines, EU Clinical Trials Directive and Research Governance Framework (Scottish Executive 2001) in order to protect the research subject and quality of each study. Provide expert clinical advice and support to other members of the multidisciplinary team with regard to IC GCP and research governance requirements, project development, implementation and completion for each clinical research study in order to ensure the safe and accurate conduct of the research Initiate and implement the development of new research protocols to the multi disciplinary team in conjunction with the Chief Investigator in order to ensure that the effective management, resource implications, and care requirements of the patients are fully considered in each study. Support and mentor any junior research staff with regard to their workload. Contribute in conjunction with key stakeholders the future service provision and planning of the oncology research nurse delivery service within the oncology directorates in relevant health boards across the SCRN region. Lead clinical practice developments in the oncology research nursing role and work collaboratively with the clinicians to develop and expand the service. Education 10% Assess the training and education implications of each protocol and work with the Chief Investigator/Research Coordinator to develop appropriate strategies to meet these in order to ensure the safe and accurate implementation of the study by self and others. Undertake additional training in order to acquire the knowledge and skills needed to implement new study protocols from a variety of oncology clinical specialities. Teach and advise patients on their condition and instruct them as necessary for any trials related or self care activities to be undertaken in order to maximise compliance with the protocol to promote their safety and well being. Teach and advise patients and carers with regard to their treatment options, both within standard care and clinical trials. Provide expert clinical advice and education on study eligibility, and protocol requirements to all grades of medical staff, pre- and post registration nurses and Allied Health Professionals. Clinical 40% Act as an expert resource for cancer research by promoting the service and increasing awareness of staff in the local cancer units to enhance standards of care. For example informing the clinical team of available trials for the relevant patient groups at multidisciplinary meeting and clinics. Take responsibility for the safe delivery of all aspects of cytotoxic drug administration following completion of a University accredited course, Assessment of the patient prior to each chemotherapy dosing and use professional judgement and highly developed clinical skills to determine the need to refer to any other member of the multidisciplinary team. Take responsibility for the development, implementation, delivery of care, and evaluation of care for patients within oncology clinical trials to ensure a high standard of care and compliance with the protocol.

9 Research 60% Develop and maintain expert knowledge of each research protocol including procedures and documentation to ensure the safe and accurate conduct and recording of the study. In collaboration with Investigators develop and utilise study specific documentation to ensure that data is recorded accurately and in accordance with regulatory requirements. Identify, screen and recruit subjects into research studies according to the inclusion and exclusion criteria, and where desired or necessary, facilitate a subject s withdrawal from a study, in order to ensure the effective achievement of the study aims. Provide ongoing advice and information to subjects, and where indicated in a protocol, obtain written consent on behalf of the Chief Investigator, in order to facilitate effective informed consent. Using expert skills and knowledge, the post-holder will undertake analysis and assessment of each patient s condition to establish the continuing care plan, appropriate action and future participation in the study. Responsible for reporting adverse events and serious adverse events in a timely and effective manner at local level and escalate as appropriate which require statutory reporting regardless of competing activity. Participate in clinical trial monitoring internally and externally as required in order to meet the governance requirements of each study. Participation in Audits by external bodies as required. Initiate audits of any new nurse services (such as nurse led clinics) to evaluate specified outcomes. Responsible for entering patients onto the EDGE Database 7a. EQUIPMENT AND MACHINERY Post holder is expected to have knowledge and ability to use all equipment used in the area however may not have daily clinical involvement. Equipment will vary according to the requirements of individual research studies. Generic Specialised Very Specialised Temperature controlled Freezers Dry Ice and Wet Ice Centrifuges Database /Computers Blood Pressure Machine Cardiac Monitor Pulse Oximeter Fire Equipment Glucometer, Tendon Hammers Defibrillator semi automatic and manual Pneumatic Tube System Suction Equipment Electrocardiograph Oxygen Cylinders Cool Caps Intubation Equipment Wheelchairs, Trolleys Stethoscopes Infusion Devices Studies have new highly specialised electronic equipment and techniques that require training with the development of standard operating procedures, dependant on the study requirements Yearly competencies maintained in cytotoxic administration.

10 7b. SYSTEMS Maintaining electronic spreadsheets and databases that meet the requirements of each study and comply with Data Protection legislation. Maintenance of up-to-date information on the progress of research studies Ensuring secure back up, storage and archiving of electronic study data Human Resource Administration System. DATIX Intranet Manage Incident Reporting Apex Laboratory System Specimen Results Internet and Intranet Personal and Business CEPAS chemotherapy prescribing and scheduling system Radiotherapy Diary Rad Diaries Scottish Cancer Research Network EDGE Database Standard Operating Procedures Electronic CRFs (on an individual basis) Study specific computer activities Paper-based Systems Maintenance, secure storage and archiving of Study Site Files and other research records 8. ASSIGNMENT AND REVIEW OF WORK The Post holder s work is generated from the research activities within the Scottish Cancer Research Network and the trials of individual investigators within the breast unit. The post-holder will screen, clinically assess and manage an unpredictable and highly complex caseload of patients. This will be balanced with the workload of the larger research team. The post holder will be responsible to the Network Manager for the Scottish Cancer Research Network who will provide clinical guidance and professional management, work review and formal appraisal of performance. The post is self-directed in terms of workload management and duties are performed without direct supervision. Workload will be assigned by the Network Manager or Investigator(s). The post holder will have responsibility for managing a self-defined workload within professional guidelines. Workload will be variable as there will be a requirement to attend clinics, multidisciplinary meetings, and to treat patients in a number of different trials for a number of different investigators. This work may be across a number of sites within NHS Lothian. The post holder will support the data management team in balancing and prioritising the current trial portfolio to ensure workload is balanced and prioritised. Workload will be variable dependant on the number and status of research studies. This may demand flexibility of working hours to take account of study recruitment patterns.

11 9. DECISIONS AND JUDGEMENTS Will make clinical and professional decisions on a daily basis regarding the nursing management of patients. This can include providing expert information and advice to the multidisciplinary team. The post holder will provide clinical and professional advice relating to the conduct of clinical research to the multidisciplinary team. Freedom to act: The post holder is expected to be self-directed and to work autonomously within broad occupational guidelines and policies in order to address a broad range of priorities and responsibilities across different teams, specialities, departments and care settings. The post holder will use informed clinical decision making with regard to the patients health care, through stringent monitoring of the patients condition and acting on clinical judgements. Patients are referred to other specialities by the post holder, such as plastic surgery, clinical psychology and physiotherapy as appropriate based on clinical findings and under the guidance of medical staff.. Having an expert understanding of the patient journey and the ability to negotiate and prioritise research time alongside daily clinical care. 10. MOST CHALLENGING/DIFFICULT PARTS OF THE JOB Breaking bad news to patients or discussing issues related to local recurrence of their breast cancer or metastatic disease. This information is often unexpected and can lead to an emotionally challenging atmosphere as the patient and their relatives can find it difficult to accept that their disease is now incurable and that their life expectancy is reduced. This requires a high level of emotional effort. Highly developed interpersonal and communication skills are required to deal with these situations whilst ensuring appropriate follow-up and support for these patients is provided. Expertly manage a highly complex patient group. This includes patients on blinded trials when actual treatment is unknown whilst administering potentially toxic treatments. Balancing the primacy of respect for patient autonomy with meeting study recruitment targets. Achieving a balance between the demands of direct patient care and existing resources in a complex dynamic environment.

12 11. COMMUNICATIONS AND RELATIONSHIPS Internal: Communicate and liaise with patients regarding the delivery of their care on a daily basis. Communication with patients may involve complex clinical and research information in order to secure informed consent. The post-holder can occasionally be responsible for providing and receiving highly complex and sensitive information related to their ongoing treatment therapies and options within a clinical trial or as part of their standard care. There can be significant barriers to understanding or acceptance of this information as the patients and their families can be extremely distressed if given information that their current treatment is no longer curative. Liaise and share knowledge and expertise with other research nurses in the cancer network within the division and nationally. Communicate and negotiate services with the pathology department, imaging department, laboratory services, inpatient wards in the breast unit, and bed managers for arranging treatment for patients undergoing clinical trials. Communicate with Data managers regarding approval process, monitoring and general management of the study. Providing frequent mentoring and input into data management teams to help them manage their workload and improve team working with the larger multidisciplinary team. This includes both informal day to day support and leading formal meetings to discuss these issues. Communicate with the Network Manager and Investigators regarding subjects condition, workload issues and personal development. Communicate with the Investigators, the relevant clinical leads for each SCRN team, and the SCRN network manager regarding trial related activity. Communicating with clinical staff, secretaries and management to ensure provision for nurse led service, including support of clinics, monitoring numbers and cancellations of clinics. Communicate with the Research and Development Office regarding the approval of, management and monitoring of clinical research studies. Communicate with other relevant departments that will include Estates, Supplies, Human Resources, Fire Officer, Infection Control, Education, Research and Development, Pharmacy, Health and Safety and Risk Management regarding issues in clinical research area and personal development. External Communications; Liase with other study centres and external multidisciplinary research teams on the day-to-day running of studies. Participate in, and where appropriate, present at external professional meetings/conferences related to the research studies. Liase with collaborators and sponsor organisations. Where appropriate, liaise with external research bodies e.g. Medicines and Healthcare products Regulatory Agency (MHRA), Central Office of Research Ethics Committee (COREC), NHS Research Scotland (NRS). Liaison with other health boards and R and D departments in the running of clinical trials. Liaison with community health team in arranging continuity of care for patient participating in clinical trials

13 12. PHYSICAL, MENTAL, EMOTIONAL AND ENVIRONMENTAL DEMANDS OF THE JOB Physical Skills: There is a requirement for speed and accuracy in dealing with research subjects, equipment and data management with narrow margins for error. The physical skills will vary according to study requirements and the post holder is required to acquire new physical skills and knowledge as studies dictate. Venepuncture Collection of Blood and Urine samples using a variety of different systems as supplied by trial sponsors Administer intravenous injections, subcutaneous, and or intra-muscular injections, syringe pumps and infusions. Removal of sutures / clips. 12-lead ECGs. Intravenous additives. Blood Glucose monitoring. Basic life support. Semi-automatic Defibrillator. Advanced maintenance of patient s airway (ambu-bagging). Reconstitution of trial agents Management of vascular access devices Physical Demands: The post will require a flexible approach to working hours in order to meet the requirements of the research protocols and subject recruitment, and there will a requirement to work unsocial hours as necessary. Mental demands of the job Regularly manage an unpredictable, diverse, highly specialised and complex caseload. Prioritising and managing competing demands within a complex environment. High levels of concentration required when checking documents/patient notes and calculating drug dosages, whilst subject to frequent direct and indirect interruptions from patients, relatives and the multidisciplinary team. Maintenance of precise and accurate research records. Challenging inappropriate or poor clinical practice. Recognising and responding to ethical issues that may arise during a study Time management Communication difficulties (multidisciplinary, multicultural, deaf, blind) Organisational changes

14 Education of staff within and in areas outside the cancer centre Continued awareness of possible reaction to trial medication with this group of patients and class of drugs Negotiation skills required to initiate and expand nurse led service within larger multidisciplinary team High levels of concentration required due to the nature of role expansion with autonomous nurse led service Challenging poor or inappropriate clinical practice Organisational or service changes, including changes that may be instigated by post holder Adapting to unfamiliar surroundings during outreach work in different hospitals. Emotional demands of the job Dealing with very distressed, anxious, worried patients and relatives who may be occasionally confrontational. Where appropriate, seeking informed consent from research subjects in a situation where persuasive and motivational skills need to be balanced with respect for the subject s autonomy. Breaking bad news and supporting patients and carers. Supporting the educational, coping, and physical care needs of patients and families with advanced cancer and a limited life expectancy in the uncertain clinical trial environment. Balancing the demands of maximising recruitment with respect for patients and other ethical dimensions. Where relevant, supporting patients who are participating in studies that offer their only possible treatment hope/option in end of life situations. Communicating complex issues with the patients or multidisciplinary team including issues related to incurable disease. Requesting participation in a research study during a critical point in the subject s care or the relative s experience of that care. Environmental and working conditions: Exposure to body fluids several times each shift. Exposure to verbal aggression high frequency. Temperature / air quality of working environment. Ergonomics. Where relevant, requirements to travel or undertake home visits. Crowded working conditions Travel out with Edinburgh on occasion as required to other areas in the south east of Scotland and to study meetings. 13. KNOWLEDGE, TRAINING AND EXPERIENCE REQUIRED TO DO THE JOB Minimum required to undertake the role; First Level Registered Nurse with relevant experience and able to demonstrate the appropriate competencies and skills for the job.

15 Managing a number of trials patients on a number of clinical trials, requiring expert communication skills, in depth knowledge and experience of the clinical speciality. The post-holder will be required to demonstrate excellent team working skills with capacity to work using own initiative. Highly developed listening and interpersonal skills in negotiating, influencing and implementing change. Time management skills/ability to prioritise workload. Extensive research experience including awareness of ICH GCP Guidelines, EU Clinical Trials Directive and Research Governance Framework. Relevant understanding and practical experience of chemotherapy administration, venepuncture, and venous access devices. IT and database management skills 14. JOB DESCRIPTION AGREEMENT A separate job description will need to be signed off by each jobholder to whom the job description applies. Job Holder s Signature: Head of Department Signature: Date: Date:

16 Section 4: NHS Lothian Values into Action NHS Lothian is determined to improve the way their staff works so they have developed a set of common values and ways of working which they now need to turn into everyday reality - to the benefit of everyone working in the organisation and, most importantly, to the benefit of their patients. Our Values are: Quality Dignity and Respect Care and Compassion Openness, Honesty and Responsibility Teamwork Throughout the recruitment process candidates will need to demonstrate they meet all of Our Values. More information on Our Values can be found by clicking on the link at the bottom of our Careers website front page: Section 5: General Information for Candidates Data Protection Act 1998 Please note that any personal information obtained from you throughout the recruitment process will be collected, stored and used in line with the Data Protection Act Information will be available to the recruiting manager and to the Human Resource staff. Counter Fraud NHS Lothian is under a duty to protect the public funds it administers, and to this end will use the information you have provided on your application form for the prevention and detection of fraud. It will also share this information with other bodies responsible for auditing or administering public funds for these purposes. More detail on this responsibility is on NHS Lothian s intranet (Counter-Fraud and Theft page) and further information is available on the Audit Scotland website: References All jobs are only offered following receipt of two satisfactory written references. At least one reference must be from your current/most recent employer, or your course tutor if you are currently a student. If you have not been employed or have been out of employment for a considerable period of time, you may give the name of someone who knows you well enough to confirm information given and to comment on your ability to do the job. Disclosure Scotland Where a Disclosure or Protection of Vulnerable Groups Check is deemed necessary for a post, the successful candidate will be required to undergo an appropriate check. Further details on the Recruitment of Ex-Offenders are available from the recruitment centre. Work Visa If you require a Work Visa, please seek further guidance on current immigration rules which can be found on the Home Office website: or visit our Careers website:

17 Overseas Registration and Qualifications NHS Lothian will check you have the necessary professional registration, where appropriate. If you require a qualification for this role but are not regulated by a professional body (e.g. NMC, GMC, HCPC etc), you will need to provide an official translation, notarised by a solicitor, of your overseas qualifications to be checked by the recruiting manager. Please ensure that this is available before applying for this post. Job Interview Guarantee Scheme As a Disability Symbol user we recognise the contribution that all individuals can make to the organisation regardless of their abilities. As part of our ongoing commitment to extending employment opportunities, all applicants who are disabled and who meet the minimum criteria expressed in the job description will be guaranteed an interview. Terms and Conditions For an overview of our Agenda for Change terms and conditions please click on this link: Travel Expenses Travel expenses are not normally reimbursed for interviews, if you are selected for interview and wish to enquire about the possibility of being reimbursed then the request should be directed to the recruiting manager or interview panel chair. Application Form Completion The purpose of an application form is to help evidence that the applicant has all the requirements applicable to carry out the job applied for. (7500 is the character limit for statement in support of application.) Once in receipt of the application pack it is essential to read both the job description and person specification to gain a full understanding of what the job entails and the minimum criteria required. Please note for equal opportunity purposes NHS Lothian do not accept CV s as a form of application. For general help and advice on how to complete an application form please visit our careers website:

18 Section 6: Working in Edinburgh and the Lothians NHS Lothian offers excellent career prospects and a wide range of job opportunities for potential employees. It employs approximately 24,000 staff and offers training and development opportunities as well as excellent staff benefits. The information provided below aims to help support and guide both prospective applicants and new employees unfamiliar with Edinburgh and the Lothians. Edinburgh and the Lothians Edinburgh and the Lothians are on the eastern side of Scotland s central belt in the heart of the country. Four main areas make up Edinburgh and the Lothians Edinburgh, East, Mid and West Lothian. NHS Lothian serves a population of approximately 850,000 people living in and around Edinburgh, Scotland s historic capital city. The geographical area known as Lothian region covers 700 square miles, comprising the City of Edinburgh, Midlothian, East Lothian and West Lothian. It is a region of exceptional beauty and contrast, from the splendour of Edinburgh to the beauty and variety of the hills, countryside and coastline. The nearest major town outside of Edinburgh is Livingston, a thriving location in the heart of West Lothian. As well as many sites of historic interest, the region boasts a host of recreational activities for all ages. For further information on relocating to Edinburgh please visit our careers website: spx Section 7: Workplace Equality Monitoring NHS Lothian is committed to supporting and promoting dignity at work by creating an inclusive working environment. We believe that all staff should be able to fulfil their potential in a workplace free from discrimination and harassment where diverse skills, perspectives and backgrounds are valued. In order to measure and monitor our performance as an equal opportunities employer, it is important that we collect, store and analyse data about staff. Personal, confidential information will be collected and used to help us to understand the make-up of our workforce which will enable us to make comparisons locally, regionally and nationally. Section 8: Equal Opportunities Policy Statement NHS Lothian considers that it has an important role to play as a major employer and provider of services in Lothian and accepts its obligations both legal and moral by stating commitment to the promotion of equal opportunities and elimination of discrimination.

19 The objectives of its policy are that no person or employee receives less favourable treatment on the grounds of sex, disability, marital status, age, race (including colour, nationality, ethnic or national origin), creed, sexuality, responsibility for dependants, political party or trade union membership or activity, HIV/AIDS status or is disadvantaged by conditions or requirements which cannot be shown to be justifiable. Our Equal Opportunities in Employment policy can be viewed on our careers website: Section 9: Code of Conduct for Healthcare Support Workers If this post is a healthcare support worker position the post holder will need to follow the Code of Conduct for Healthcare Support Workers. A Healthcare Support Worker is defined as any healthcare worker working within NHS Scotland who is not currently statutorily regulated or in a role that has been recommended for statutory regulation by the Government. The Code of Conduct sets the standard of conduct expected of healthcare support workers and adult social care workers. It outlines the behaviour and attitudes that you should expect to experience from those workers signed up to the code. It helps them to provide safe, compassionate care and support. For more information on the Code of Conduct for Healthcare Support Workers please read the guidance: