1. Job Summary

The post-holder will assist in the provision of a clinical research service. You will be responsible for assessing and managing the care pathways for patients and carers participating in clinical trials focused mainly on mental health and dementias. This will involve the recruitment, education and monitoring of research participants and the collection and documentation of accurate data and may include collection and management of samples. You will work collaboratively with the research team and wider multi-disciplinary teams in the management of clinical trial patients. The role involves using an in depth knowledge of trial protocols and their application in practice, alongside a working knowledge and compliance with the local, national and international research regulations. This post would suit someone with a desire to engage in, or experience, hands-on clinical trials/research.

2. Network Summary

The National Institute for Health Research (NIHR) is funded through the Department of Health to improve the health and wealth of the nation through research.

The NIHR Clinical Research Network (CRN) is the clinical research delivery arm of the NHS in England, tasked with supporting the rapid set-up and effective conduct of studies, so that researchers can gather the robust evidence needed to improve treatments for NHS patients. These local Networks drive clinical research delivery performance across the locality, and champion the role of clinical research in the NHS at every level. EPUT sits within CRN North Thames.

3. Key Areas of Responsibility

3.1 Clinical

Plan and coordinate your day to day work in collaboration with the Research Team Lead and/or Study Coordinator

Manage a caseload of people who have consented to participate in certain studies

Undertake study procedures required and in line with the research protocol

To provide ongoing follow up care whilst patient is in the clinical trial

Provide accurate and timely information, education and support to patients (and their significant others) regarding clinical research

Maintain accurate documentation

Have an understanding of adverse event reporting and recording and ensure that the Study Coordinator or Principal Investigator are made aware of any such events

Act at all times in a way that maintains carers’ and patients’ dignity

Refer to other specialists as required in order to provide optimal patient care

3.2 Research

Work according to Good Clinical Practice and research governance standards for all aspects of work practice

Set up, conduct and management of studies

Assessing feasibility of studies prior to set up

Adhere to clinical study protocols and report protocol deviations and violations to study coordinator.

Have an awareness of legislation and the Mental Capacity Act; take informed consent as per study protocols.

Register/randomise patients into studies.

Assist in the identification of patients eligible to enter clinical studies

Ensure that clinical trial records are accurately maintained.

Ensure that own case report forms are accurately completed, in paper and electronic format.

Communicate effectively with the rest of the study team and patients/carers.

Actively promote research within EPUT

Keep up to date with departmental, Trust, NHS, and EU developments for the management of clinical research

Input to recruitment strategies. Support and assist in the development of action plans as required

Preparation in the event of inspection from a regulatory and/or monitoring authority.

Provide support for clinical trial colleagues in their absence.

Attend meetings relevant to the nature of the job.

Travel as required to research locations across the organisation

3.3 Administration

Use computer network and the internet.

Ensure tha