Job summary
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:
o Seeking ongoing informed consent as a voluntary agreement with research study participants, ensuring their understanding of the research and its risks
o Identification, screening, and randomisation of research study participants
o 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.
Main duties of the job
The purpose of this post is to increase the number of people participating in research studies ELFT, by:
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Assisting clinical teams and NHS services in identifying and recruiting participants in research studies, including service users, carers, and staff
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Providing information and support for patients, carers and staff enrolling in research projects
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Facilitating delivery of study procedures in line with the study protocol, performing baseline assessments of study participants
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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.
About us
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.
Job description
Job 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 Trusts incident reporting policies, including timely and appropriate referral.
Prepares initial and follow-up adverse event reports in liaison with clinical staff.
Person Specification
Education/ Qualification/ Training
Essential
- oUndergraduate degree (2:1 or above) in psychology, healthcare, nursing, social sciences, or a related discipline.
Desirable
- oICH-GCP Training (Good Clinical Practice).
- oPostgraduate qualification in health and social care, or related social sciences field.
Experience
Essential
- oExperience in health or social care settings with direct service user contact, ideally within the NHS.
- oDelivering face-to-face and remote healthcare or research activities, including participant recruitment.
- oFamiliarity with mental health or community care services and patients
Desirable
- oManaging qualitative and quantitative data.
- oEngaging diverse demographic groups.
Knowledge and Skills
Essential
- oFamiliarity with a range of mental illnesses.
- oBasic understanding of research methodology and participant recruitment strategies.
- oExcellent interpersonal skills, demonstrating listening with empathy, compassion, and patience.
- oAbility to engage with busy clinicians and service users.
- oAbility to communicate study information clearly to clinicians and service users.
- oUnderstanding of informed consent processes.
- oAbility or willingness to be trained in phlebotomy.
- oCapable of maintaining accurate study files and service user Case Report Forms.
Desirable
- oUnderstanding of research governance and ethics.
Other
Essential
- oSolution-focused approach to challenges.
- oAbility to work under pressure and independently while being an effective team member.
- oStrong time management skills, including workload prioritization.
- oWillingness to undergo necessary training to support the study portfolio.
- oCommitment to work in-person a minimum of 40% of the time.
- oAbility to travel independently for research visits, including to patients' homes or offsite locations.
- oCommitment to personal and professional development.
Desirable
- oAdaptable working hours to meet project needs
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.
Certificate of Sponsorship
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Employer details
Employer name
East London NHS Foundation Trust
Address
Trust HQ
9 Alie Street
London
E1 8DE
United Kingdom
Employer's website
https://www.elft.nhs.uk/ (Opens in a new tab)
This listing was aggregated from publicly-available sources. The employer holds an A-rated sponsor licence at the time of this listing, but sponsorship of this specific role is not guaranteed — the employer's offer and UK Visas and Immigration are the final authority. Details may have changed since our last update — verify with the employer via the Apply link.