Clinical Research Assistant

Overview

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.

Responsibilities

• Collect, record and maintain data for patients and volunteers on research studies, supporting research staff to ensure completeness, accuracy and consistency of data to meet reporting standards for regulatory bodies.
• Support clinical trials activities such as preparing, handling and processing biological samples, data management and resolution, in accordance with the clinical trial protocol and Good Clinical Practice (GCP).
• Ensure compliance with UHL policies on data protection, confidentiality and security.
• Provide the highest standards of patient care in line with research protocols and ICH GCP guidelines, safeguarding patient well-being and data integrity.
• Collaborate with Principal Investigators and the research team to deliver a high quality research service, offering clinical expertise, professional advice, support, guidance and education to the multi-professional team, patients and carers within the research service.
• Assist with acquisition and distribution of relevant trial documentation and study equipment/tools, ensuring health and safety checks are carried out in accordance with Trust Policies.
• Assist in preparation and submission of documentation for clinical research approvals; create and maintain trial site files for each trial in accordance with ICH-GCP and Research Governance.
• Collect patient data from medical notes and complete case report forms (CRFs), liaising with clinical trials coordinators, research nurses and investigators to ensure accurate data collection.
• Transcribe/export data from medical records (paper or electronic) to CRFs (paper or electronic e-CRFs) as required by the study protocol.
• Ensure safe filing and storage of study documentation and conduct quality assurance of documentation.
• Organise and prepare for visits by trial monitors as required by the study protocol; liaise with clinical trial units regarding data queries and resolve data queries.
• Support assessment of patient eligibility in liaison with other appropriate health care professionals, coordinating pre-study tests, obtaining results and arranging appointments as per protocol.
• Provide written and verbal information relevant to the research study and support clinical staff in obtaining informed consent from participants entering clinical research.
• Handle telephone enquiries from staff, patients and relatives and inform appropriate personnel for actions to be taken.
• Report adverse events to the appropriate research nurse and/or principal investigator (PI); present specific trial information at multidisciplinary team meetings.
• Act professionally when dealing with patients, relatives and representatives; coordinate specified trials and manage the following tasks: organization of tests/investigations, sample preparation, low-risk clinical duties, maintenance of logs and temperatures for stored samples, keeping stock levels of kits, monitoring temperatures during and outside office hours, organizing diagnostic specimen logistics including packaging and shipment (dry ice), resolving data queries raised by sponsors, archiving study materials post-closure, and reporting Serious Adverse Events (SAEs).
• Notify General Practitioners of patient involvement in a clinical trial; participate in new post-holder training and induction, with opportunities to upgrade skills through meetings and workshops.

About the Trust and Working Context

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 services for the residents of Leicester, Leicestershire and Rutland. We work with partners at the University of Leicester and De Montfort. Our strategy (2023-2030) focuses on high-quality care, being a great place to work, partnerships for impact, and research and education excellence, with a commitment to embedding health equality in all we do.

UHL is an equal opportunities employer and invites applications from diverse backgrounds. We provide flexible working arrangements where practicable and include pre-employment checks such as Disclosure and Barring Service (DBS) checks and COVID-19 risk assessments as part of the process. We aim to reflect the communities we serve in our workforce.