Site University College London Hospital
Town London
Salary £35,964 - £43,780 Per annum inclusive of HCAS
Salary period Yearly
Closing 20/02/2025 23:59
The use of AI is monitored and if applicants have used it, then they are required to declare this in their supporting statement.
Job overview
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 across two CRF sites as required and based on needs.
Main duties of the job
1. Facilitate and actively engage in data collection, data entry/management
2. Assist in reconciling AE/SAE data
3. Develop source documentation for the trial ensuring all protocol requirements are being collected working closely with the study nurses and research fellows
4. Manage the maintenance of the Investigator Site Files (ISF), ensuring all essential documents are filed contemporaneously
5. Lead preparation and facilitation of monitoring visits with external sponsors
6. Identify and recruit healthy volunteers to trials, ensuring recruitment according to the research protocol
7. Provide administration support to Clinical Trial Coordinators and other CRF staff, assisting with documentation, filing and distribution as required
8. Processing of amendments in a timely manner, including the notification, R&D approval request and implementation liaising with service support departments
9. Assist with archiving of trials once they have closed, following up with sponsor for missing documentation
Person specification
Knowledge and Qualifications
* First degree in scientific/healthcare related discipline or equivalent experience
* Understanding of UK Clinical Trials Regulations, the European Directives on Clinical Trials and the UK Policy Framework for Health and Social Care Research
* Knowledge of Good Clinical Practice (GCP) and good knowledge and understanding of other related standards such as Good Clinical Laboratory Practice (GCLP) and Good Manufacturing Practice
Experience
* Experience of working in and/or conducting research in health or social care setting
* Experience of systematic data collection and entry
* Experience in the clinical trial recruitment processes
Skills and Abilities
* Excellent administrative and organisational skills
* Flexible and supportive approach to team working, and a proactive approach to develop and document systems and procedures
* Outstanding organisational skills, managing several projects that are often time pressured, concurrently
* Ability to prioritise activities in spite of conflicting pressures
* Ability to maintain adherence to written procedures
* Keen to remain up to date with current and new research legislation and guidance and willing to undertake further training related to this as required
* Excellent IT skills, including Word, Excel, PowerPoint, Access/databases and the Internet/email
Communication
* Proven ability to communicate effectively verbally
At UCLH, we have a real ‘One Team’ ethos, and our values – safety, kindness, teamwork and improving, are central to the way we work.
UCLH recognises the benefits of flexible working for staff and has a dedicated policy which allows staff to apply for flexible working right from the beginning of employment.
This vacancy may close before the current listed closing date. You are advised not to delay submitting your completed application.
Please note that all correspondence regarding your application will be via email. The emails will be sent to you via TRAC.jobs and not via NHS Jobs, we encourage you to check your inbox regularly.
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