Clinical Research jobs in United Kingdom

Job summary

The SJUH Leeds Clinical Research Team is recruiting!

The Research and Innovation Department is continuing its exciting expansion. We have several research specialities and the Early Phase Research portfolio is looking for a B5 Associate Clinical Research Practitioner.

This is a full-time post (1.0 WTE), with a temporary contract (12 months) due to a secondment period with the expectation to be extended. This post will be based at SJUH Clinical Research Facility, Bexley Wing.

The post holder will contribute actively to the conduct, coordination, and delivery of the Early Phase Research Portfolio. The main tasks are: Deliver Early Phase Clinical Research studies, facilitate patient care and clinical visits, and successfully communicate with the multidisciplinary teams required. In addition, they will be responsible for ensuring that high standards of clinical care planning, delivery, safety, and patient satisfaction are maintained, in compliance with Trust policy, study protocol requirements, local and national guidance, and legislation.

The successful candidate will ensure that research undertaken within the department safeguards the wellbeing of patients and is conducted within the confines of ICH Good Clinical Practice Guidelines for Research, EU directive, UK Governance Framework, and other relevant UK legislation pertaining to the conduct and delivery of research.

Main duties of the job

We are looking to recruit a proactive and self-motivated clinical research practitioner with experience coordinating clinical trials and a keen interest in research to work within Early Phase Research.

The post-holder will work closely with both junior and senior colleagues, as well as members of the MDT to deliver high-quality clinical care to patients during their participation in both interventional and observational studies. The post will cover both inpatient and outpatient settings with the caseload varying in size and complexity according to the trial portfolio.

The post holder will work alongside industry partners, the National Institute for Health Research (NIHR) Clinical Research Network (CRN) Yorkshire and Humber (Y&H), and colleagues in neighbouring establishments, attending regional and national meetings as required.

If you are interested in the post, we encourage you to contact the recruiting manager for an informal discussion.

Expected Shortlisting Date: 07/02/2025

Planned Interview Date: 17/02/2025

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 five 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 offering an extensive programme of education and training tailored to meet the needs of individuals and teams involved in clinical research delivery in Health and Social Care.

Our five Trust values are part of what makes us different. They have been developed by our staff and are:

1. Patient-centred
2. Collaborative
3. Fair
4. Accountable
5. Empowered

Leeds Teaching Hospitals is committed to 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 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. A 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, such as 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

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

THE LEEDS WAY VALUES

Our values are part of what make us different from other trusts, so we see this as a 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:

1. Patient-centered
2. Collaborative
3. Fair
4. Accountable
5. 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

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 maintaining excellent interpersonal skills.

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.

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 ongoing 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 Trust's 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 participant's 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 the ongoing 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 into 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.

Education and Training

Person Specification

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

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 issues surrounding research ethics, drug development, and management

Qualifications

Essential

• Educated to degree level or equivalent, or be able to demonstrate relevant experience commensurate with this post
• AHCS registered
• GCP trained

Desirable

• Working towards AHCS registration
• Informed consent trained
• Care Certificate

Other Criteria

Essential

• Able to fulfil Occupational Health requirements for the post.
• Willing to undergo training as necessary
• Ability to demonstrate clinical skills and be able to teach relevant skills to other staff.

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

Employer details

Employer name
Leeds Teaching Hospitals
Address
St. James's University Hospital
Beckett Street
Leeds
LS9 7TF
Employer's website