Job Description
We are looking for an enthusiastic and motivated team member with good interpersonal and organisational skills to work in our busy NIHR Biomedical Research Centre- Respiratory theme based at Glenfield Hospital and Leicester Royal Infirmary Research Departments.
The successful candidates will require excellent communication skills, and the ability to work well under pressure.
The post holder will support current portfolio research in ensuring the completeness, accuracy and consistency of the data in order to meet standards expected for reporting to regulatory bodies.
The individuals will 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.
The role will provide research support to clinical specialties conducting research at UHL in particular studies in TB and infection. The working hours are generally between Monday – Friday.
The post holder will provide the highest standards of patient care in line with research protocols and will ensure that such research safeguards the well-being of the patients and is conducted within ICH Good Clinical Practice guidelines for research.
The post holder will work alongside Principle Investigators and the research team to assist in the delivery of a high quality research service and ensure the highest standard of care 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 14,000 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)
KEY RESPONSIBILITY AREAS
- Research Trial Set Up and Initiation
- Assist with the acquisition and distribution of relevant trial documentation/equipment
- To establish trial site files for each trial in accordance with ICH-GCP and research governance
- To transcribe/export data from medical records (paper or electronic) to CRF’s (paper or electronic) as required by the study protocol
- Facilitate the secure filing and storage of study documentation in accordance with ICH- GCP and Research Governance and conduct quality assurance of documentation
- Organise and prepare for visits by trial monitors as required by the study protocol
- Take responsibility for liaising with clinical trials units/study sponsors regarding data queries and for checking and resolving data queries
- 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 protocols
- Have a solid understanding of the application of ICH GCP Guidelines, the EU Directive on Clinical Research and Research Governance
- To ensure patients / carers are provided with written information relevant to the research study and are given the opportunity to discuss the research study or clinical trial adequately at the outset and during the course of the research or clinical trial in which they are being asked to participate (i.e. informed consent
- Attend and support patients in the clinical environment for monitoring, assessment and follow up as part of research project
- Where appropriate, to take consent from patients/participants to enter research studies
- To take relevant patient samples for clinical trials; such as blood samples, to centrifuge and separate serum, package and dispatch as per defined protocols, where appropriate
- Maintain accurate patient trial documentation, complete Case Record Forms, including the use of electronic data capture systems and ensure relevant information is recorded in patients’ medical notes
Ensure safety data is reported to required SOPs and study protocols, and reports sent in a timely manner
- To ensure safe and appropriate storage of specimens in accordance with the trial protocol and in conjunction with specialist team
- To record and report any adverse and serious adverse events according to trial protocol and local procedure
- 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
R&I Directorate
1. Identify personal educational needs associated with participation in current clinical trials and ensure these are effectively communicated to the Research Manager. Participates in the development of an agreed personal development plan to meet identified needs
2. Ensure safe standards of practice through identification of areas of risk associated with participation in clinical trials. Ensure clinical trial protocols and appropriate professional guidelines are adhered to
3. Participate in the implementation of research practice standards
4. To undertake mandatory training as required by the individual Trusts and additional clinical, research and IT training as required by the research studies
5. Work to SOP’s, applicable regulatory requirements and laws as per required and applicable to each research study, department and Trust
6. Manages a personal caseload of clinical trials and patients independently with minimal supervision/mentoring from Principle Investigators/senior research nurses/team leaders
7. To ensure relevant approvals are in place prior to commencing each trial
8. To ensure all work is undertaken in line with the research protocol, ICH-GCP and Research Governance guidelines
9. To act as one of the primary points of contact for clinical trials patients/ parents
10. To educate other staff as to the responsibilities of the role and function of the research nurse and disseminate information on specific studies
11. Observe patients and monitor treatment/toxicity side effects; escalating findings accordingly
12. To maintain Professional Accountability for nursing research practice at all times
13. Identifies, screens and recruits patients for the clinical trial using agreed protocols in accordance with ICH-GCP and Research Governance
14. Provides education and support for patients in research trials
15. Work with the lead clinician to evaluate clinical trial proposals, identifying potential patient populations and evaluating cost implications of the trial
16. Work with the Ethics and Governance team to ensure all clinical trial documentation has appropriate ethical committee and Trust approval providing feedback to the lead clinician and research directorate.
17. Participate in set-up/initiation/monitoring visits, site audits and study close-down meetings carried out by sponsoring organisations and regulatory authorities
18. Provide on-going audit reports as required by the trial protocols and Research & Innovation department/ethics committee
19. Responsible for resolving data queries raised by sponsoring organisations
20. Demonstrates commitment to the role of patient advocate for patients and families considering or participating in clinical trials
21. To provide mentorship and supervision for other research professionals and staff within and outside the department
22. Act as a resource for ward based nurses wishing to undertake research once competencies have been achieved
23. Responsible for assisting with the completion of study costing templates along with assisting with invoicing and the recovery of income for commercial research as per financial contract agreement
24. Act as a role model for excellence in research.