Job summary
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.
Main duties of the job
o Facilitate and actively engage in data collection, data entry/management
o Assist in reconciling AE/SAE data
o Develop source documentation for the trial ensuring all protocol requirements are being collected working closely with the study nurses and research fellows
o Manage the maintenance of the Investigator Site Files (ISF), ensuring all essential documents are filed contemporaneously
o Lead preparation and facilitation of monitoring visits with external sponsors
o Identify and recruit healthy volunteers to trials, ensuring recruitment according to the research protocol
o Provide administration support to Clinical Trial Coordinators and other CRF staff, assisting with documentation, filing and distribution as required
o Processing of amendments in a timely manner, including the notification, R&D approval request and implementation liaising with service support departments
o Assist with archiving of trials once they have closed, following up with sponsor for missing documentation
About us
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:
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.
Job description
Job responsibilities
For the full Person Specification and more information regarding the main responsibilities of this role, please refer to the attached Job Description.
Come and be a part of the best NHS trust in England to work for, according to our staff*
UCLH top trust to work at in England for the second year running! : University College London Hospitals NHS Foundation Trust
*In the most recent NHS staff survey UCLH had the highest percentage of staff who said they would recommend us as a place to work, out of all general acute or acute/community NHS trusts in England for the second year in a row.
UCLH top trust to work at in England for the second year running! University College London Hospitals NHS Foundation Trust.
Once again, UCLH has received the highest score of all general acute and acute/community NHS trusts in England for staff that would recommend us as a place to work.
To discover more about what makes UCLH a great place to work, visit: Why Choose UCLH?
Job description
Job responsibilities
For the full Person Specification and more information regarding the main responsibilities of this role, please refer to the attached Job Description.
Come and be a part of the best NHS trust in England to work for, according to our staff*
UCLH top trust to work at in England for the second year running! : University College London Hospitals NHS Foundation Trust
*In the most recent NHS staff survey UCLH had the highest percentage of staff who said they would recommend us as a place to work, out of all general acute or acute/community NHS trusts in England for the second year in a row.
UCLH top trust to work at in England for the second year running! University College London Hospitals NHS Foundation Trust.
Once again, UCLH has received the highest score of all general acute and acute/community NHS trusts in England for staff that would recommend us as a place to work.
To discover more about what makes UCLH a great place to work, visit: Why Choose UCLH?
Person Specification
Knowledge and Qualifications
Essential
- 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
Essential
- Experience of working in and/or conducting research in, health or social care setting
- Experience of systematic data collection and entry
Desirable
- Experience in the clinical trial recruitment processes
Skills and Abilities
Essential
- 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
- Good eye to detail
Communication
Essential
- Proven ability to communicate effectively verbally
Person Specification
Knowledge and Qualifications
Essential
- 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
Essential
- Experience of working in and/or conducting research in, health or social care setting
- Experience of systematic data collection and entry
Desirable
- Experience in the clinical trial recruitment processes
Skills and Abilities
Essential
- 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
- Good eye to detail
Communication
Essential
- Proven ability to communicate effectively verbally
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Additional information
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Employer details
Employer name
University College London Hospitals NHS Foundation Trust
Address
University College London Hospital
235 Euston Road
London
NW1 2BU
Employer's website
https://www.uclh.nhs.uk (Opens in a new tab)
