JOB PURPOSE
The post holder will be responsible for the safe delivery of direct and indirect care and associated source data collection for clinical research studies undertaken in the department. The post holder will be responsible for the assessment, planning, coordination, implementation and evaluation of individualised care plans for clinical trials participants. Additionally, they will provide patient centred care and support clinical trial participants focusing on high quality patient experience. The post holder will be involved in raising awareness and embedding research within LTHT and offering people opportunities to take part in research as part of their standard care pathway.
They will act as a member of the multidisciplinary team, advising and supporting the clinical teams with research related matters and will also maintain their clinical skills. Flexible Working Pattern may be required to support the development of clinical trial services at weekends or evenings that best suit the needs of the research speciality teams and trial participants. Working at different external sites for example Care Homes, Schools or other community settings may be required. During exceptional times of need, they will contribute to clinical service, as agreed with the Head of Nursing/AHP and in line with the Trust's escalation policy.
JOB DIMENSIONS
The post holder will work within a specialised environment caring for participants enrolled in clinical research studies. The exact dimensions of the numbers and types of studies may vary in accordance with the dynamic nature of the research programme and specialist clinical area.
KNOWLEDGE, SKILLS AND EXPERIENCE REQUIRED
1. Qualifications: Educated to degree level or equivalent, or be able to demonstrate relevant experience commensurate with this post - Academy for Healthcare Science (AHCS) registered.
2. Experience: Experience of clinical trials delivery and working in the NHS. Experience in facing patients.
3. Training: Ability to demonstrate clinical skills and be able to teach relevant skills to other staff. Willing to undergo relevant training as necessary. Undertaking and maintaining International Conference of Harmonization Good Clinical Practice training is a requirement of the post.
4. Skills: Literate and numerate. Competent in written and verbal communication skills. Competent in the use of information technology. Able to organise and prioritise workload. Understand the skills and knowledge required to develop team members. Maintaining and advancing clinical skills relevant to the clinical speciality.
Knowledge: Current issues in research delivery and in health care. Basic understanding of research methodology. Awareness of the roles and responsibilities of clinical research staff.
Personal Attributes: Ability to work as part of a team, reliable and trustworthy. Committed to working with people. Demonstrates a commitment to own personal development. Compassionate, enthusiastic and motivated. Flexible and adaptable. Professional and patient focused. Courageous.
CORE BEHAVIOURS AND SKILLS
1. Ability to act professionally at all times.
2. Effective communication skills.
3. Effective numeracy skills.
4. Ability to organise self and others.
5. Teaching and assessing skills.
6. Team player.
7. Effective time management skills.
8. Good organisation skills and ability to prioritise workload.
9. Upholding reflective practice and maintain excellent interpersonal skills.
CORE KNOWLEDGE AND UNDERSTANDING
1. An understanding of research and evidence based practice.
2. An understanding of the organisation and working practices of the speciality.
3. An understanding of the process and philosophy of mentorship.
4. An understanding of the training and development needs of other junior staff and students.
PRINCIPAL DUTIES AND AREAS OF RESPONSIBILITY
1. Communicate with patients and carers to ensure that they have access to appropriate information.
2. Maintain and deliver compassionate patient focused care in accordance with LTHT guidelines, policies, values and behaviours.
3. Provide assessment, planning, implementation and evaluation of nursing research care for patients, ensuring documentation standards are upheld in accordance with good Clinical Practice (GCP) and LTHT guidelines, whether written or computerised.
4. Act in a way that safeguards the health and wellbeing of children and vulnerable adults at all times. Be familiar with and adhere to the LTHT safeguarding policies.
5. Maintain a safe working environment.
6. Promote and maintain positive relationships between all staff involved in the care of patients in line with the Leeds Way.
7. Promote and implement evidence based practice.
8. Continue to expand and maintain clinical skills appropriate to the clinical area of practice.
9. Undertake duties on other wards or departments as and when required by service demands or patient need.
Research
1. Ensure that research studies are undertaken in accordance with study protocols, the terms approved by the Health Research Authority (HRA), National Research Ethics Committee, the Trust Research & Innovation (R&I) Office and all other required regulations.
2. Adhere to national and local Research Governance Framework and legislative requirements to ensure delivery of the highest level of care to research participants.
3. Follow local policies, standard operating procedures (SOPs), and study specific protocols in relation to the research speciality.
4. Provide advice and information to participants in order to facilitate initial and on-going informed consent.
5. This may include obtaining informed consent as delegated by the Principal Investigator and as indicated in the study protocol, and with ethical committee and R&I Department approval, ensuring that the patients rights are upheld throughout the study.
6. In line with the Trust's appropriate SOP, additionally training and competency assessment will also be required prior to taking on the delegated responsibility of taking informed consent.
7. Identify, screen and recruit participants into research studies according to inclusion and exclusion criteria, and where necessary, facilitate a participants withdrawal from a study.
8. Maintain effective written and verbal communications with research participants, relatives and other members of the multidisciplinary/research team to ensure research participant needs are met and appropriate information is shared and documented, including on-going process of informed consent.
9. Have an overall awareness of potential risks within the clinical area assessing these at all times (including patient behaviours and working environment) to ensure the health and safety of research participants, visitors and staff and compliance with related legislation and guidelines.
10. Act as the research participants advocate and uphold the quality of each study at all times; this will include assessment, planning and evaluation of individualised care plans as per study protocol.
11. Report adverse events and serious adverse events in accordance with the Trust SOPs and study protocols in a timely and effective manner with reference to the Senior Research Nurse/Midwife/AHP and Principal Investigator.
12. Resolve complaints timeously at a local level and escalate as appropriate.
13. Be responsible for accurate and secure data collection, storage and entry in to case report forms (both paper and electronic) that meet Data Protection Act requirements, including secure backup of study data, as per information governance and study specific guidance.
14. Participate in facilitating clinical trial monitoring in order to meet the safety, integrity and governance requirements of each study.
15. Where relevant, ensure that the processing and storage of human biological samples meets the necessary requirements of the Human Tissue Act, local SOPs and research protocol so that safe handling and quality is assured.
16. Order and maintain trial specific supplies according to study protocols, procedures and regulations and level of recruitment ensuring that resources are used appropriately and efficiently at all times.
17. Participate in the audit and evaluation of clinical practice in the interests of promoting and improving quality care through action on findings.
18. Have direct involvement in the provision of education and development of pre-registration, appropriate post-registration students and other members of the multidisciplinary team to ensure that appropriate learning opportunities are provided and students feel supported.
19. Have direct involvement in delivering relevant clinical care to Trial participants in accordance with their plan of care.
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