Clinical Studies Assistant/Research nurse

ELFT has long been recognised as a centre of excellence for mental and health care, innovation and improvement. So it is a very exciting time for you to come and work for us. Our mission is to make a positive difference to people's lives by improving quality of life for all we serve. Our values are: We Care, We Respect, We are Inclusive – so we are looking for people who live and breathe these qualities when supporting service users and carers, and in their relationships with colleagues in the Trust and our partner organisations.

Job overview

The research delivery workforce is a vital resource; their skills and expertise ensure that patients and the economy benefit from a vibrant research culture as an integral part of health and care for all. The research delivery team are involved in a range of activities, including:

• Seeking ongoing informed consent as a voluntary agreement with research study participants, ensuring their understanding of the research and its risks

• Identification, screening, and randomisation of research study participants

• Ensuring high quality data input at source and its management through a research workflow

Clinical Studies Assistants are a core part of the research delivery workforce that specialise in consent, data collection, and other study protocol activities. This is a varied role involving work across multiple studies, services, and teams. Postholders will be expected to spend a minimum of 40% of time on site, either across services or at their designated base.

The post-holder will be responsible for liaising with busy clinicians, identifying and recruiting service users into a portfolio of studies to meet targets within agreed timelines, conducting baseline assessments, and maintaining accurate site files and case report files. They will also provide additional support to study teams when necessary and actively promote research among clinicians, service users, and the wider NHS community.

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This is a patient facing role and will require the post-holder to be in-person 4 days a week.

The purpose of this post is to increase the number of people participating in research studies ELFT, by:

1) Assisting clinical teams and NHS services in identifying and recruiting participants in research studies, including service users, carers, and staff

2) Providing information and support for patients, carers and staff enrolling in research projects

3) Facilitating delivery of study procedures in line with the study protocol, performing baseline assessments of study participants

4) Assisting the efficient set up and delivery of studies within ELFT, thus contributing to the performance metrics set for the Trust by the Regional RDN.

Contributing to the development of a culture within the Trust where research is actively promoted at all levels.

Working for our organisation

Our mission is to make a positive difference to people's lives by improving the quality of life for all we serve. Our values are: We Care, We Respect, We are Inclusive – so we are looking for people who live and breathe these qualities when supporting service users and carers, and in their relationships with colleagues in the Trust and our partner organisations.

Detailed job description and main responsibilities

Research Context

· Demonstrate a comprehensive understanding of the portfolio of studies taking place in the Trust.

· Demonstrate a practical understanding of how the principles of Good Clinical Practice (GCP) are implemented using everyday examples of their working practice.

· Be able to discusses their individual contribution to delivering research in the NHS and understand the role of their colleagues.

· Be able to identify different study types (e.g., interventional, observation) and design (e.g., randomised, double-blind) and explain what these terms mean.

· Monitor compliance with governance requirements and promptly report any non-compliance issues to line manager.

Study set-up

· Establish trial site files compliant with research governance and GCP requirements.

· Assists in the organisation of trial documentation for study set-up.

· Contribute to feasibility assessments under supervision.

· Demonstrate a broad awareness of the approvals required to conduct research in the NHS studies and the processes by which these approvals are obtained.

· Completes the delegation log for a new trial & demonstrates understanding of delegated duties.

· Assist in identifying suitable clinical services, wards, or departments for participant recruitment.

· Under supervision, collaborate with clinical services during the study set-up phase.

· As required, attend site initiation visits with the Principal Investigator, research team and clinical staff to ensure effective study launch and protocol understanding.

Study delivery

· Liaise with clinical teams to promote research studies and ensure appropriate referrals and recruitment of participants.

· Identify, screen, and recruit participants in line with protocol-defined inclusion and exclusion criteria, adhering to national and local approvals.

· Clearly explain studies to service users, address their questions, and obtain informed consent in accordance with GCP principles.

· Provide comprehensive information about studies to service users, and where appropriate extending this information to families, and treating clinicians to ensure informed decision-making.

· Where appropriate apply capacity assessment at consent and baseline visit.

· Proactively seeks documentation to confirm informed consent has been provided by the participant; and Identifies errors/concerns in documents.

· Undertakes collection of biological samples (including blood & phlebotomy) in line with local & national regulations

· Facilitate delivery of baseline measures in line with the study protocol e.g. psychological assessments.

· Contribute to the collection and reporting of local recruitment data by maintaining updated screening and recruitment logs as required.

· Regularly monitor and report study recruitment progress, identify areas of low recruitment, and work with line manager to implement strategies for improvement.

· Contribute to the development of policies and standard operating procedures (SOPs) to support adherence to protocols.

Data Management

· Collect, collate, and manage research data in strict adherence to study protocols, ensuring accuracy and completeness.

· Establish and/or maintain in-house and sponsor documentation systems and accurate study contacts.

· Creates and maintains research files according to standard operating procedures (SOPs); demonstrates an ability to manage version control of study documents.

· Maintain meticulous and accurate patient records, ensuring all relevant study information is documented in medical notes and source documentation; identify and seek to correct incomplete, inaccurate, or misleading documentation or data entry.

· Undertake the accurate and complete collection of data, and insertion of data into case report forms (CRFs) and other study-related documentation; identify errors and inconsistencies between CRFs and source data and seek to resolve these.

· Ensure that all data collection and storage meet the requirements of study protocols, research governance, and data protection legislation.

· Facilitate accurate and timely recording of patient recruitment data using the EDGE Data Entry System.

· Has a robust understanding of what constitutes a data breach/ confidentiality breach and raises concerns when processes to ensure confidentiality are not adhered to.

· Prepare documents and facilities for monitoring visits and work with the study monitor during visit; respond to auditing and monitoring recommendations.

· Contributes to study closure and preparation of documents for archiving, liaising with the sponsor and R&I department.

Patient Care

· Articulates their own responsibilities and recognises the boundary of their own role and when to refer to others.

· Raise concerns and report instances of suspected protocol deviation.

· Identify and escalate patient risks to the appropriate care team during study visits, ensuring timely intervention.

· Record and report incidents of harm or near misses in line with the Trust’s incident reporting policies, including timely and appropriate referral.

· Prepares initial and follow-up adverse event reports in liaison with clinical staff.

Making Things Better

Quality Improvement is a key part of our work to improve our services and refine how we do things. We have a global reputation for our quality improvement work and we don’t stand still! So we offer a fantastic opportunity for our staff to learn, lead and contribute towards improving our services.

We launched our Five Year Strategy in April 2018, which identified four main strategic outcomes to improve: population health outcomes, experience of care, staff experience and improve value. This complements the NHS Long Term Strategy and sets out our direction of travel.

Our Community

We provide a wide range of community health and mental health inpatient services to children, young people, adults of working age, and older adults in The City of London, Hackney, Newham, Tower Hamlets, Bedfordshire and Luton. We provide Forensic services to the whole of North East London. We provide services in urban and rural settings, sometimes in our inpatient units, but mostly in the community close to where people live. Integrated care is key in making the best use of resources and providing effective care.

Aiming High

East London NHS Foundation Trust has achieved its third consecutive ‘Outstanding’ rating from the Care Quality Commission; the first Community and Mental Health Trust to achieve this rating for a third time. We were named in the HSJ’s Top 10 best places to work in healthcare and were voted Provider Trust of the Year in 2018.

Staff and Service Users United

We strive to ensure that staff feel valued by the Trust and as they are truly pivotal in delivering better outcomes for our patients and service users. Our aspiration is to help to make ELFT the best place to work. This Trust is clinician-led and provides the highest possible level of clinical expertise throughout its services. We pride ourselves on our service user involvement. A service user will be on your assessment centre and interview panel if you are invited to meet us.

We especially welcome people with lived experience of health difficulties, with insight and understanding of different backgrounds, cultures and lifestyles in our population as we believe that this will equip staff to deliver a high standard of care to our service users and patients.

Diversity

ELFT Is committed to being a diverse organisation and our workforce is reflective of the population and communities we serve. We believe that having colleagues with a range of backgrounds and life experiences enriches and adds value to the outcomes we have set out to achieve. Having partnered and endorsed by organisations who are representative and experts in various areas of equality and diversity, we can ensure we are meeting the pre-set standards all the way from recruitment stage throughout the career journey of our employees by being accessible, having fair inclusive practices and a host of staff networks to support, nurture and celebrate our valued staff in the workplace.

Other reasons to apply

As a flexible working friendly organisation, we want to be sure that you can work in a way that is best for us and for our patients, and for you. Speak to us about how we might be able to accommodate a flexible working arrangement whether that’s job share, part time or another flexible pattern.

As part of the relocation scheme we presently have, the Trust could support you with offering up to £8,000 for removal and associated expenses. This is subject to change and terms and conditions apply.

AI in applications

If you use AI or other tools to assist in writing your job application, make sure you add your own personal touch especially in the supporting information section. AI can make writing easier, but it doesn’t fully understand the position you’re applying for and might generate false or misleading information. Applications written only by AI often sound generic and may not show your real skills, knowledge, or experience. It’s important to write your supporting statement in your own words. East London NHS Foundation Trust does not recommend relying only on AI, as it could negatively impact on your chance of success in the application process.

We carefully check applications to make sure no one has an unfair advantage, and we verify all references. At the interview, you’ll be asked about your experience, so be honest and ensure everything in your application is accurate. Please remember that using AI during the interview is not allowed.

What Next?

If you like the sound of ELFT, don’t waste a moment. We sometimes close adverts early if there is a high response, so apply now!

As part of our recruitment process we may be required to share information you provide on the application form with NHS Counter Fraud Authority (NHSCFA) and/or other organisations for the purpose of the prevention, detection, investigation and prosecution of fraud or any other unlawful activity affecting the NHS. We also use third party providers to check and verify your qualifications who may be contacting you on our behalf to verify the same..

If you do not hear from us within four weeks of the closing date, please consider that you have not been shortlisted on this occasion. You must provide professional email addresses for all referees as we will contact them as soon as an offer has been made. Please note we do not request references prior to interviews. All applications made through NHS Jobs account will be processed by TRAC System. Please note that some emails may go to your spam/junk mailbox so make sure you check this regularly.

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