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
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
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
Use computer network and the internet.