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Job requirements
Requirements from the employer’s person specification. These describe the role, not your personal match.
Essential
19 listedRequirements the employer expects applicants to meet.
- Other
Solution-focused approach to challenges.
- Other
Ability to work under pressure and independently while being an effective team member.
- Other
Strong time management skills, including workload prioritization.
- Other
Willingness to undergo necessary training to support the study portfolio.
- Other
Commitment to work in-person a minimum of 40% of the time.
- Other
Ability to travel independently for research visits, including to patients’ homes or offsite locations.
- Other
Commitment to personal and professional development.
- Experience
Experience in health or social care settings with direct service user contact, ideally within the NHS.
- Experience
Delivering face-to-face and remote healthcare or research activities, including participant recruitment.
- Experience
Familiarity with mental health or community care services and patients
- Knowledge and Skills
Familiarity with a range of mental illnesses.
- Knowledge and Skills
Basic understanding of research methodology and participant recruitment strategies.
- Knowledge and Skills
Excellent interpersonal skills, demonstrating listening with empathy, compassion, and patience.
- Knowledge and Skills
Ability to engage with busy clinicians and service users.
- Knowledge and Skills
Ability to communicate study information clearly to clinicians and service users.
- Knowledge and Skills
Understanding of informed consent processes.
- Knowledge and Skills
Ability or willingness to be trained in phlebotomy.
- Knowledge and Skills
Capable of maintaining accurate study files and service user Case Report Forms.
- Education/ Qualification/ Training
Undergraduate degree (2:1 or above) in psychology, healthcare, nursing, social sciences, or a related discipline.
Desirable
6 listedAdditional qualities the employer would prefer.
- Other
Adaptable working hours to meet project needs
- Experience
Managing qualitative and quantitative data.
- Experience
Engaging diverse demographic groups.
- Knowledge and Skills
Understanding of research governance and ethics.
- Education/ Qualification/ Training
ICH-GCP Training (Good Clinical Practice).
- Education/ Qualification/ Training
Postgraduate qualification in health and social care, or related social sciences field.
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.
Main duties of the job
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.
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. |
Applicant requirements
The postholder will have access to vulnerable people in the course of their normal duties and as such this post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service to check for any previous criminal convictions.
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Applying for this NHS job
This advert is for Clinical Studies Assistant/Research nurse with East London NHS Foundation Trust in London, England. It is listed as a Band 5 Nursing assistant role. The advertised salary is £38,488 - £46,852 Per Annum (pro rata if Part Time) inc HCA. The contract type is Fixed term: 12 months (N/A). The application deadline is 01 Oct 2026.
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