Associate Clinical Research Practitioner

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

Willing to undergo training as necessary Willing to undergo training as necessary Ability to demonstrate clinical skills and be able to teach relevant skills to other staff. GCP trained Informed consent trained Care Certificate Able to fulfil Occupational Health requirements for the post.

Experience

Essential

Experience in clinical trials delivery Experience of working within the NHS Experience facing patient activities Current issues in health care and research An awareness of the roles and responsibilities of clinical research staff Basic understanding of research methodologies

Desirable

Understanding of Clinical Research including issue surrounding research ethics, drug development and management

Skills & behaviours

Essential

Patient centred Caring, compassionate and motivated Reliable and trustworthy Excellent interpersonal and organisational skills Good written and verbal skills Good time management Able to provide and be responsible for the assessment, planning, implementation and evaluation of individualised research care plans in line with trial protocols Ability to support participants whilst on clinical trials and provide patient focused care Good IT skills Ability to organise and prioritise workload Ability to communicate and work effectively within a multi-disciplinary team

Desirable

Capable of lateral thinking Clinical skills Electronic data entry Information Technology skills

Qualifications

Essential

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 AHCS registered

Desirable

CRP registered or working towards registration

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