Clinical Trials Research Assistant

2 weeks ago

Leicester, United Kingdom University Hospitals of Leicester NHS Trust Full time

This is a great opportunity to work in the HOPE Cancer Trials Centre. We have an ever changing diverse portfolio of clinical haematology and oncology trials including those exploring compounds at the early stages of development.

Working predominantly on oncology and haematology trials, you will liaise closely with clinical research nurses and other members of the multi-disciplinary team. You will be responsible for collecting, recording and maintaining data for patients on Phase 1, 2 & 3 clinical trials as well as playing an important role in ensuring that clinical trials are conducted according to Good Clinical Practice.

Preferably with a background in research and/or a Health Science degree, you need to be highly organised, have an eye for detail and be an excellent communicator. IT literacy is essential, as well as a proven ability to prioritise and meet deadlines.

We are an established busy oncology and haematology clinical trials unit. That works links with a local charity Hope against cancer. We run over 100 trials consisting of Phase 1, 2 & 3 clinical trials. You will be working alongside multi disciplinary team members ie nurses, doctors, pharmacy and study support officers.

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 clinical support to patients in clinical trials such as taking samples, performing tests and physical measurements in accordance with the clinical trial protocol and Good Clinical Practice (GCP). To ensure compliance with UHL policies on data protection, confidentiality and security.

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. They are:
We focus on what matters most
We treat others how we would like to be treated
We are passionate and creative in our work
We do what we say we are going to do
We are one team and we are best when we work together

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.

About the University Hospitals of Leicester NHS Trust (leicestershospitals.nhs.uk)

1. To assist with the acquisition and distribution of relevant trial documentation.
2. 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.
3. To assist in the preparation and submission of documentation for clinical research approvals.
4. To create and maintain trial site files for each trial in accordance with ICH-GCP and Research Governance.
5. 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.
6. To transcribe/export data from medical records (paper or electronic) to CRFs (paper or electronic e-CRFs) as required by the study protocol.
7. To ensure safe filing and storage of study documentation in accordance to research governance.
8. Conduct quality assurance of documentation.
9. To organise and prepare for visits by trial monitors as required by the study protocol.
10.To take responsibility for liaising with clinical trial units regarding data queries and for checking and resolving data queries.
11.To evaluate 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.
12.Demonstrates commitment to the role of patient advocate for patients considering or participating in clinical trials.
13.To provide written and verbal information relevant to the research study and gain informed consent from participants for entering into clinical research, where the necessary approvals are in place to do so.
14.To deal with telephone enquiries from staff, patients and relatives, ensuring that

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