Clinical Research Practitioner

Clinical Governance / Quality Compliance with ICH GCP Understand publications that will directly affect the role, responsibilities and accountability of the Research Practitioner, eg UK Policy Framework for Health and Social Care Research. Accept responsibility for own personal, professional development and education needs, including the attendance of in-service mandatory training and statutory study days. Adhere to Trust and Local Risk Management Strategy and Trust Incident Reporting policy. Adhere to and promote Trust Behavioural Standards. Adhere to, and promote Trust Infection Control policy and actively participate in Trust approach to infection prevention and control. Present an appearance which gives a positive image of the Trust and a manner which is appropriate and inspires confidence. To ensure that all patient information is confidential. Compliance with the Data Protection Act. Compliance with NHS Code of Confidentiality. Education and training development To keep appropriate staff informed of the progress of clinical research. To maintain an awareness of current advances in research practice and maintain own professional development. To maintain links with other clinical research practitioners across the local research network to develop and share knowledge and to provide mutual support. To attend local and national meetings in relation to clinical research as required. Equality and Diversity It is the responsibility of every member of staff to understand our equality and diversity commitments and statutory obligations under current equality legislation (the

Equality Act 2010) and to

Act in ways that support equality and diversity and recognises the importance of peoples rights in accordance with legislation, policies, procedures and good practice; Valuing people as individuals and treating everyone with dignity and respect, consideration and without prejudice, respecting diversity and recognising peoples expressed beliefs, preferences and choices in working with others and delivering appropriate services; Recognise and report behaviour that undermines equality under Trust policy. Be consciously aware of own behaviour and encourage the same levels of behaviour in colleagues. Acknowledge others different perspectives and recognise the diverse needs and experiences of everyone they come into contact with. With the support of managers develop an equality and diversity objective through the personal development review process. Values and Behaviours We are Caring We are kind to each other and always show compassion to ourselves and others. We know we are doing this when: We are always kind and compassionate to ourselves, our patients, families and colleagues; We recognise and appreciate each other, taking pride in working here and our contribution to success; We are professional and always seek to deliver the best standards of care. We are Fair We treat people equitably and value their differences. We know we are doing this when: We value everyone for their unique contribution and we embrace diversity; We are confident in speaking up and we support all our colleagues to do the same; We are open and honest. We Are Innovative We work as a team to continuously improve the way we deliver and transform health care. We know we are doing this when: We continuously improve the services we deliver and pioneer new ways of doing things; We learn from mistakes, striving to ensure we get things right first time; We create and share knowledge with each other, patients and our professional communities. Infection Prevention & Control All staff will adhere to infection control policies and procedures at all times and carry out role specific duties as per roles and responsibilities. Confidentiality Confidentiality/Data Protection regarding all personal information and Trust activity must be maintained at all times (both in and out of working hours). All staff should ensure that they are familiar with and adhere to all Trust privacy, confidentiality and security policies and procedures. Any breach of confidentiality will be taken seriously and appropriate disciplinary action taken. Freedom of Information In accordance with Freedom of Information and other associated legislation, the Trust may be required to make public recorded information available upon a request, or do this as part of a publication scheme. Please note, that in your public role, your name or job role may be contained in a document that is published in accordance with such legislation. Management of Risk & Health and Safety All employees have a duty to take reasonable care to avoid injury to themselves or to others and to co-operate with the Trust in meeting its statutory requirements. All employees will proactively contribute to the management of risk by identifying hazards in the workplace which have the potential to cause harm, raising issues of concern and risk to the appropriate level. Safeguarding Children and Vulnerable Adults All trust employees are required to act in such a way that at all times safeguards the health and wellbeing of children and vulnerable adults. Familiarisation with and adherence to trust Safeguarding policies is an essential requirement of all employees, as is participation in related mandatory/statutory training. IT Skills All staff are expected to have or to gain a minimum of basic level IT skills to enable them to use the Trust IT systems to support Trust services and needs. All staff should be familiar with relevant IT systems and security policies and procedures. Records Management All staff are personally responsible for record keeping. A record is anything that contains information in any medium e.g. paper, tapes, computer information, etc. which have been created or gathered as a result of any NHS activity. All individuals within the Trust are responsible for any records they create or use. Please ensure that records are retained in accordance with the Records Management Policy and are stored in a manner that allows them to be easily located in the event of a Freedom of Information (FOI) request. Information Quality All staff must ensure complete and accurate data is collected to the highest standard at all times. Data collection should be supported by adequate documentation and processes should be regularly reviewed. Staff should ensure that processes conform to national standards and are fit for purpose. All staff should comply with the Information Quality Policy. Professional Responsibility As per any required registration & LUHFT policy. Communication Responsibility To provide research advice to patients and their families concerning the care and treatment during participation in research. To provide information in an appropriate forum. To be responsible for maintaining strong relationships and positive communication channels with all participating members of each study and staff involved in the studies. To ensure all communication is evidenced and documented as required by governance standards. Clinical Responsibility Co-ordinate the care and support of their own case load of clinical research participants. Work alongside other research staff assigned to the studies to provide complementary support to the research team. Assist in identifying patients who are suitable for entry into agreed research studies. Ensure that study specific investigations are undertaken as required by the study protocol(s), in order to establish eligibility and safety to enter the studies. Ensure appropriate samples are collected as required by the study protocol(s). Accurately document data collected. Assist with the recording and reporting of all adverse events that occur as part of the clinical research in accordance with the Trust procedures for pharmacovigilance and the study protocol(s) and delegated responsibilities. Maintain accurate and legible patient notes (written and electronic) in accordance with Trust and professional code of practice. To facilitate the recruitment process and to provide ongoing follow up care, this may require visits to other sites or visits to patients home. To understand and adhere to local Trust policies and procedures across the Network. Administration Responsibility Some administrative tasks are required to support research activity. Research To disseminate information to colleagues in respect of the research studies taking place within the clinical areas. To identify and screen eligible patients for participation in the research studies. To facilitate the informed consent and recruitment of research participants. To assist with the development of strategies to overcome barriers to recruitment. To be aware of ethical considerations of research and act as the patients advocate at all times. To be fully conversant with the requirements of the clinical research study protocol in relation to patient management, data collection and safety reporting. To carry out the collection, processing and shipping of biological specimens according to protocol requirements and follow-up appropriately. Maintain accurate records and undertake the data management including the use of data software packages. Actively contribute to activities, events and training within the research teams. To contribute to evidence based practice and maintain overall standard of care for patients at all times.