Associate Clinical Research Practitioner | University Hospitals of Leicester NHS Trust
We are seeking an experience clinical associate research practitioner to join Research and Innovation (R&I) department at University Hospitals of Leicester NHS Trust, Glenfield hospital as part of the NIHR Biomedical Research Centre – Respiratory and Infection Theme.
The post holder should be adaptable, flexible and show initiative. In addition they need to show good communication skills, be able to liaise with all levels of staff, demonstrate good organisational skills and attention to detail, have good time management skills and be flexible as the working hours may not be fixed.
This post holder will be required to work across sites with the infection team to facilitate clinics predominantly at the Leicester Royal Infirmary and Glenfield Hospital.
The post-holder may be required to work in other research areas across UHL if service needs arise.
This post will predominantly be a Monday - Friday office hours however may need flexibility depending on the study requirements.
The post holder will support current portfolio research staff in ensuring the completeness, accuracy and consistency of the data in order to meet standards expected for reporting to regulatory bodies. The individual 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.A key responsibility of the role will be to support research within the Research Team at Glenfield hospital as part NIHR Biomedical Research Centre- Respiratory and infection theme and take responsibility for the co-ordination and facilitation of concurrent research studies.
The post holder will ensure compliance within UHL Trust policies on data protection, confidentiality and security. The role will provide clinical research assistant support to the ITU Team conducting research at UHL.
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.
Our new strategy, developed with the support and feedback of colleagues, patients, and partners, is our compass for the next seven years (2023-2030).
We have four primary goals:- high-quality care for all,
- being a great place to work,
- partnerships for impact, and
- research and education excellence
And we will embed health equality in all we do - taking active steps to reduce the avoidable differences in healthcare that some people face, working in partnership with communities.
Our strategy is underpinned by new values and we will work to ensure they are an everyday reality for all:- we are compassionate,
- we are proud,
- we are inclusive, and
- we are one team
This is an exciting moment as we look to the future with clarity on what we already do well and where we need to focus our energies to make an even bigger difference for the people we serve.
About the University Hospitals of Leicester NHS Trust:
http://www.leicestershospitals.nhs.uk/aboutus/work-for-us/current-vacancies/- Research Trial Set Up and Initiation
- Assist with the acquisition and distribution of relevant trial documentation/equipment.
- Provide assistance in the preparation and submission of documentation for Ethical Approval and the NIHR CSP and EDGE process
- To establish 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 forms (CRF’s) and to liaise with clinical trial co-ordinators, research nurses and investigators to ensure accurate data collection
- 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 projects
- 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
- Observe patients and monitor treatment toxicity/side effects; escalating findings accordingly
- 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 teams
- To record and report any adverse and serious adverse events according to trial protocol and local procedure.
- Contribute to effective communications within the CRN East Midlands, including preparation and delivery of regular presentations and reports.
- Establish and maintain effective working relationships with all relevant organisations and individuals, including member NHS Trusts, other NIHR Clinical research networks and other providers of NHS services within the CRN, Clinical Trials Units, Industry, and NHS commissioners.
- 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 Friday 4 Oct 2024