About this role
Job summary
Reporting to the JRO Quality Assurance Manager, a talented individual is sought to provide support in further development and delivery of the quality management and assurance system for the UCLH and UCL research portfolio within the JRO (Joint Research Office).
A proactive self-starter with excellent organisation and analytical skills with a proven understanding of data systems. You will be responsible for maintaining systems for the tracking and analysis of research incidents reported via Trust or UCL platforms. These systems include but are not limited to recording each incident, tracker maintenance to include analysis of trends and preparation of reports as required. You will provide guidance and advice in respect of reporting research incidents together with specific incident advice. You will be included in our audit program to audit processes, systems and the non-commercially sponsored research studies within the JRO portfolio.
You should demonstrate a pragmatic approach with proven excellent communication skills. You will be expected to communicate effectively with senior clinical researchers, academic researchers, colleagues from within the designated research units across the NHS Trust and UCL.
The post holder will be required to maintain a good working relationship and a high level of customer service with the teams within the JRO, Trust, University as well as external stakeholders.
Main duties of the job
1. Liaise with investigators, UCLH and UCL research divisions and units to offer support and guidance relating to research incident reporting, process, guidance and SOPs.2. Liaise with external stakeholders to provide quality advice and guidance on incident management, regulatory issues and research management in the implementation of research policy, e.g. implementation of the GCP regulations, HRA, Data Protection Act, UK GDPR, Human Tissue Act, Material Transfer, SOP's and Policies relating to the JRO research portfolio.3. Prepare reports for dissemination at regular Quality and Safety meetings to reflect reported research incidents, outcomes and analysis.4. To report on trends within reported research incidents and provide analysis.5. Ensure appropriate corrective and preventative action plans (CAPA) are recorded within trackers and JRO Quality Management System QMS6. Maintain the online Quality Management System (QMS) of SOPs, associated documents and file notes. Track the compliance to the QMS of SOPs of the JRO teams using online logs.
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:
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.
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 - 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 third year in a row.
UCLH recognises the benefits of flexible working for staff To find out more, visit: Flexible working.
To discover more about what makes UCLH a great place to work, visit: Why Choose UCLH?
Person Specification
Knowledge and Qualifications Essential
Science related degree or equivalent experience Knowledge of drug development process and concept of clinical trials Knowledge of ICH GCP
Desirable
Knowledge of safety incidents in research
Experience Essential
Experience of working with clinical trials Experience of dealing with confidential information
Desirable
Experience of working in a health care setting Experience in audits Experience writing SOPs
Skills and Abilities Essential
Able to prioritise tasks and work flexibly and effectively under pressure to meet essential. Ability to work under minimal supervision. Ability to work as part of a team. Ability to prioritise own workload. Ability to work on own initiative. Excellent computer skills, including experience of Word, Excel and databases.
Values Essential
Demonstrate ability to meet Trust Values of safety, kindness, teamwork and improving
Communication Essential
Ability to communicate effectively verbally and in writing.
Personal and People Development Essential
Good eye for detail Displays enthusiastic nature. Willingness and ability to participate in continuing education in relation to role. Displays desire for professional and personal development.
Desirable
Experience delivering training.
Responsibilities towards promoting Equality Diversity and Inclusion Essential
E.g., All posts to include Demonstratable understanding of the Equality, Diversity, and Inclusion and/or Knowledge of the NHS obligations under the Equality Act 2010 and the Public Sector Equality Duties (line managers to elaborate depending on the level of the post and to assess this essential criteria at interview)
Specific Requirements Essential
Manual handling- Postholder will need to be passed fit to perform duties of post, this will be determined through occupational health with any reasonable aids provided wherever possible. Willingness to work flexible hours on occasion.
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.
Certificate of Sponsorship 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
250 Euston Road
London
NW1 2PG
Employer's website https://www.uclh.nhs.uk (Opens in a new tab)