The NIHR UCLH Clinical Research Facility UCLH is a well-established Clinical Research Facility (CRF) covering two sites. The Leonard Wolfson Experimental Neurology Centre is a dedicated neuroscience experimental medicine facility at the National Hospital for Neurology and Neurosurgery (NHNN) at Queen Square (QS); and the NIHR UCLH Clinical Research Facility is a comprehensive Cancer and Medical research facility on the Bloomsbury campus (BC) at Tottenham Court Road.
We are looking to recruit a self-motivated and enthusiastic Research Assistant to work in the CRF and support the management of a portfolio of clinical trials. The job role will be working across multiple therapeutic areas from first-into-human through to complex and innovative phase 3 trials, and experimental non-IMP studies.
The post holder will be expected to ensure high quality work in line with the study protocol, the principles of Good Clinical Practice (GCP) and the UK Medicines for Human Use (Clinical Trials) Regulations.
The post holder will be based at UCLH CRF based across two CRF sites as required and based on needs.
Key Responsibilities:
* Facilitate and actively engage in data collection, data entry/management
* Assist in reconciling AE/SAE data
* Develop source documentation for the trial ensuring all protocol requirements are being collected working closely with the study nurses and research fellows
* Manage the maintenance of the Investigator Site Files (ISF), ensuring all essential documents are filed contemporaneously
* Lead preparation and facilitation of monitoring visits with external sponsors
* Identify and recruit healthy volunteers to trials, ensuring recruitment according to the research protocol
* Provide administration support to Clinical Trial Coordinators and other CRF staff, assisting with documentation, filing and distribution as required
* Processing of amendments in a timely manner, including the notification, R&D approval request and implementation liaising with service support departments
* Assist with archiving of trials once they have closed, following up with sponsor for missing documentation
University College London Hospitals NHS Foundation Trust (UCLH) is one of the most complex NHS trusts in the UK, serving a large and diverse population. We provide academically led acute and specialist services, to people from the local area, from throughout the United Kingdom and overseas. Our vision is to deliver top-quality patient care, excellent education, and world-class research.
We provide first-class acute and specialist services across eight sites:
* University College Hospital (incorporating the Elizabeth Garrett Anderson Wing)
* National Hospital for Neurology and Neurosurgery
* Royal National ENT and Eastman Dental Hospitals
* University College Hospital Grafton Way Building
* Royal London Hospital for Integrated Medicine
* University College Hospital Macmillan Cancer Centre
* The Hospital for Tropical Diseases
* University College Hospital at Westmoreland Street
We are dedicated to the diagnosis and treatment of many complex illnesses. UCLH specialises in women’s health and the treatment of cancer, infection, neurological, gastrointestinal and oral disease. It has world class support services including critical care, imaging, nuclear medicine and pathology.
We are committed to sustainability and have pledged to become a carbon net zero health service, embedding sustainable practice throughout UCLH. We have set an ambitious target of net zero for our direct emissions by 2031 and indirect emissions by 2040.
For further details / informal visits contact: Name: Stephanie Deriziotis Job title: Clinical Studies Manager Email address: stephanie.deriziotis@nhs.net
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