Job summary
Expected Shortlisting Date:
09/12/2024
Planned Interview Date:
16/12/2024
We have an exciting opportunity for Associate Clinical Research Practitioner to join our team at The Leeds teaching Hospitals Trust. The position is part of the NIHR Leeds Biomedical Research Centre (Leeds BRC) and Research and Innovation at LTHT, The position has been created to contribute to research within the expanding field of the Spondyloarthropathy Prevention and spondyloarthritis and Rheumatology Research Portfolios. We are looking for candidates with clinical trials management experience in an NHS Trust or University or pharmaceutical company. In this role, you will be expected to work closely with the trial coordinators, nursing staff, and to liaise with medical staff involved in spondyloarthritis and Rheumatology trials. The Leeds BRC works on a wide variety of clinical trials and translational studies in the field of musculoskeletal diseases. This Associate Clinical Research Practitioner role works across multiple teams and projects including the management of national multicentre projects.
If you enjoy learning, are enthusiastic about research delivery and have great attention to detail, read on, this post may be for you.
Main duties of the job
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. in accordance with the UK Medicines for Human Use Clinical Trial Regulations. 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. During exceptional times of need, they will contribute to clinical service, as agreed with the Head of Nursing/AHP and in line with the Trusts escalation policy.
About us
Research is at the heart of our Trust. Leeds Teaching Hospitals is involved in research at all levels, developing and trialling new treatments for patients. We believe that being involved in cutting-edge research helps us provide better care to our patients. Over the next 5 years, we aim to be the best Trust to deliver high-quality clinical research and to champion research amongst our staff. We also aim to support and grow our world-class clinical infrastructure and assets for research and innovation. We have a very proactive Research Academy. It offers an extensive programme of education and training tailored to meet the needs of individuals, teams involved in clinical research delivery in Health and Social Care. Our five Trust values are part of what make us different. They have been developed by our staff. They are: - Patient-centred - Collaborative - Fair - Accountable - Empowered
Leeds Teaching Hospitals is committed to our process of redeploying 'at risk' members of our existing workforce to new roles. As such, all our job adverts are subject to this policy and we reserve the right to close, delay or remove adverts while this process is completed. If you do experience a delay in the shortlisting stage of the recruitment cycle, please bear with us while this process is completed, and contact the named contact if you have any questions.
Job description
Job responsibilities
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 Trusts 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
Qualifications
- Educated to degree level or equivalent, or be able to demonstrate relevant
experience commensurate with this post
- Academy for Healthcare Science (AHCS) registered
Experience
Experience of clinical trials delivery and working in the NHS
Experience in facing patients
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.
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
6. THE LEEDS WAY VALUES
Our values are part of what make us different from other trusts, so we see this as
strength, as well as a responsibility. They have been developed by our staff and
set out what they see as important to how we work. Our five values are:
Patient-centered
Collaborative
Fair
Accountable
Empowered
All our actions and endeavours will be guided and evaluated through these values
Additionally, the following are core values which relate specifically to this post:
Commitment to ensure high quality care is delivered
Commitment to delivering high quality evidence based care
Commitment to working in a multi-disciplinary team
Commitment to promoting a positive and creative working environment
Commitment to own development and the development of junior staff
Promotes a professional image and a positive approach to problem solving
Promotes a culture of equality, mutual respect, diversity and trust
7. CORE BEHAVIOURS AND SKILLS
Ability to act professionally at all times.
Effective communication skills.
Effective numeracy skills
Ability to organise self and others.
Teaching and assessing skills
Team player.
Effective time management skills
Good organisation skills and ability to prioritise workload.
Upholding reflective practice and maintain excellent interpersonal skills
8. CORE KNOWLEDGE AND UNDERSTANDING
An understanding of research and evidence based practice.
An understanding of the organisation and working practices of the speciality.
An understanding of the process and philosophy of mentorship
An understanding of the training and development needs of other junior staff
and students.
9. PRINCIPAL DUTIES AND AREAS OF RESPONSIBILITY
Communicate with patients and carers to ensure that they have access to
appropriate information.
Maintain and deliver compassionate patient focused care in accordance with
LTHT guidelines, policies, values and behaviours.
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.
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.
Maintain a safe working environment.
Promote and maintain positive relationships between all staff involved in the
care of patients in line with the Leeds Way.
Promote and implement evidence based practice.
Continue to expand and maintain clinical skills appropriate to the clinical area
of practice.
Undertake duties on other wards or departments as and when required by
service demands or patient need.
Research
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.
Adhere to national and local Research Governance Framework and legislative
requirements to ensure delivery of the highest level of care to research
participants.
Follow local policies, standard operating procedures (SOPs), and study specific
protocols in relation to the research speciality.
Provide advice and information to participants in order to facilitate initial and
on-going informed consent. 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
In line with the Trusts appropriate SOP, additionally training and competency
assessment will also be required prior to taking on the delegated responsibility
of taking informed consent.
Identify, screen and recruit participants into research studies according to
inclusion and exclusion criteria, and where necessary, facilitate a participants
withdrawal from a study.
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.
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.
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.
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.
Resolve complaints timeously at a local level and escalate as appropriate.
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.
Participate in facilitating clinical trial monitoring in order to meet the safety,
integrity and governance requirements of each study.
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.
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.
Participate in the audit and evaluation of clinical practice in the interests of
promoting and improving quality care through action on findings.
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.
Have direct involvement in delivering relevant clinical care to Trial participants
in accordance with their plan of care.
Person Specification
Other criteria
Essential
1. Willing to undergo training as necessary
2. Willing to undergo training as necessary
3. Ability to demonstrate clinical skills and be able to teach relevant skills to other staff.
4. GCP trained
5. Informed consent trained
6. Care Certificate
7. Able to fulfil Occupational Health requirements for the post.
Experience
Essential
8. Experience in clinical trials delivery
9. Experience of working within the NHS
10. Experience facing patient activities
11. Current issues in health care and research
12. An awareness of the roles and responsibilities of clinical research staff
13. Basic understanding of research methodologies
Desirable
14. Understanding of Clinical Research including issue surrounding research ethics, drug development and management
Skills & behaviours
Essential
15. Patient centred
16. Caring, compassionate and motivated
17. Reliable and trustworthy
18. Excellent interpersonal and organisational skills
19. Good written and verbal skills
20. Good time management
21. Able to provide and be responsible for the assessment, planning, implementation and evaluation of individualised research care plans in line with trial protocols
22. Ability to support participants whilst on clinical trials and provide patient focused care
23. Good IT skills
24. Ability to organise and prioritise workload
25. Ability to communicate and work effectively within a multi-disciplinary team
Desirable
26. Capable of lateral thinking
27. Clinical skills
28. Electronic data entry
29. Information Technology skills
Qualifications
Essential
30. Educated to degree level or equivalent, or be able to demonstrate relevant experience commensurate with this post AHCS registered CRP registered and qualified or actively working towards qualification
31. AHCS registered
Desirable
32. CRP registered or working towards registration