Clinical Studies Assistant/Research nurse

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.

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.

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.

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.

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

Desirable: - oManaging qualitative and quantitative data.; - oEngaging diverse demographic groups.

Knowledge and Skills

Desirable: - oUnderstanding of research governance and ethics.

Other

Desirable: - oAdaptable working hours to meet project needs