Clinical Research Assistant | University Hospitals of Leicester NHS Trust

This is a unique and exciting opportunity to join the Research & Innovation (R&I) workforce at University Hospitals of Leicester (UHL).

This is a great opportunity to become a member of the HOPE cancer trials team. We have an ever changing diverse portfolio of clinical haematology and oncology trials including those exploring compounds at the early stages of development. We offer a commitment to support training and professional development needs and the opportunity to develop interests and skills in the prevention, diagnosis and treatment of cancer.

There are close relationships between the Biomedical Research Centre (BRC) Themes, University of Leicester and UHL clinical areas across the 3 sites. Funding from the Clinical Research Network (CRN) will support the delivery of research programmes across all specialties at UHL.

The appointee’s main responsibilities include collecting, recording and maintaining data for patients and volunteers on research studies. To support research staff in ensuring the completeness, accuracy and consistency of the data in order to meet standards expected for reporting to regulatory bodies.

To provide support in clinical trials such as preparing, handling and processing biological samples, and data management and resolution, in accordance with the clinical trial protocol and Good Clinical Practice (GCP). To ensure compliance with UHL policies on data protection, confidentiality and security.

The post holder will provide the highest standards of patient care in line with research protocols and ICH Good Clinical Practice guidelines, safeguarding the well-being and safety of the patients and integrity of the data.

To work alongside Principal Investigators and the research team to assist in the delivery of a high quality research service of clinical expertise, professional advice, support, guidance and education to the multi-professional team, patients and carers within the research service.

The post-holder will ensure the highest standard is delivered to research subjects and, where relevant to their families, in partnership with all members of the multi professional and research teams.

We are one of the biggest and busiest NHS trusts in the country, incorporating the General, Glenfield and Royal Infirmary hospitals. We have our very own Children’s Hospital and run one of the country’s leading heart centres.

Our team is made up of more than 17,000 staff providing a range of services primarily for the one million residents of Leicester, Leicestershire and Rutland.

We work with partners at the University of Leicester and De Montfort University providing world-class teaching to nurture and develop the next generation of doctors, nurses and other healthcare professionals, many of whom go on to spend their working lives with us.

Our purpose is to provide ‘Caring at its best’ and our staff have helped us create a set of values that embody who we are and what we’re here to do.

Our patients are at the heart of all we do and we believe that ‘Caring at its best’ is not just about the treatments and services we provide, but about giving our patients the best possible experience.

• To assist with the acquisition and distribution of relevant trial documentation.
• To assist with the acquisition and distribution of study equipment/tools and ensure relevant health and safety checks are carried out in accordance with relevant Trust Policies.
• To assist in the preparation and submission of documentation for clinical research approvals.
• To create and maintain trial site files for each trial in accordance with ICH-GCP and Research Governance.
• Collection of patient data from medical notes and completion of case record form (CRF) and to liaise with clinical trials coordinators, research nurses and investigators to ensure accurate data collection.
• To transcribe/export data from medical records (paper or electronic) to CRFs (paper or electronic e-CRFs) as required by the study protocol.
• To ensure safe filing and storage of study documentation in accordance to research governance.
• Conduct quality assurance of documentation.
• To organise and prepare for visits by trial monitors as required by the study protocol.
• To take responsibility for liaising with clinical trial units regarding data queries and for checking and resolving data queries.
• To support the assessment of patient eligibility, in liaison with other appropriate health care professionals for clinical trial entry, involving coordination of pre study tests, obtaining results and arranging appropriate appointments as per clinical trial protocol.
• To provide written and verbal information relevant to the research study and support clinical staff in the process of gaining informed consent from participants that are entering into clinical research.
• To deal with telephone enquiries from staff, patients and relatives, ensuring that appropriate personnel are informed in order for actions to be taken.
• To report any adverse events to the appropriate research nurse and/or principal investigator (PI).
• Presenting specific trial information at multidisciplinary team meetings.
• To act in a professional manner at all times when dealing with patients, relatives and representatives from both within and outside of the Trust.
• Co-ordination of specified trials and take responsibility for :• Organisation of any necessary tests and investigations as detailed within the
• Sample preparation (e.g. blood, urine, tissue and faecal samples): retrieval, centrifuging, pipetting, slide making and preparation for storage, liaising with the hospital and external laboratories when appropriate.
• Undertaking low risk clinical duties.
• Maintaining logs of stored samples and freezer temperatures.
• Maintaining adequate stock levels of sample kits.
• Required to hold a phone for a short period of time to monitor freezer/fridge temperatures including during and out of office hours.
• Organising the logistical aspects of diagnostic specimens, packaging, and shipment, including handling of dry ice.
• Resolving data queries raised by sponsoring organisations.
• Archiving all study related material including patient’s notes after study closure.
• Reporting and submitting of Serious Adverse Events (SAEs) from this site within stipulated timeframes to sponsor organisations and the Research and Innovation Office.
• Tracking Serious Unexpected Event reporting.
• Maintaining and updating study specific site files.
• Notifying General Practitioners of their patient’s involvement in a clinical trial.
• As a new post holder, training will be provided for the key aspects of this role, and a period of induction identified, however, the post holder will be expected to take advantage of opportunities to upgrade their skills and to attend meetings and workshops to enhance their knowledge.

This advert closes on Thursday 31 Oct 2024