We are actively promoting flexible working options, helping you to manage a work / life balance.
Job overview
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 NIHR Biomedical Research Centre- Respiratory 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 clinical specialties conducting research at UHL.
Main duties of the job
* 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 Principal 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.
* 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.
* The post-holder may be required to work in other research areas across UHL if service needs arise.
* This post may involve shift patterns, including internal rotation onto night duty to ensure 24 hour cover (including bank holidays).
Working for our organisation
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:
1. High-quality care for all,
2. Being a great place to work,
3. Partnerships for impact, and
4. 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.
Detailed job description and main responsibilities
* 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.
Person specification
Training & Qualifications
Essential criteria
* Minimum of 5 Grade C or above GCSE/Equivalent to include English and Maths.
* Evidence of on-going professional development.
Experience
Essential criteria
* Minimum 2 years research experience or equivalent.
Desirable criteria
* Experience in respiratory specialty.
* Experience of the clinical care of patients enrolled in research studies.
Skills
Essential criteria
* Clinical skills including vital signs monitoring.
Desirable criteria
* Extended clinical skills such as Venepuncture, cannulation, spirometry or other bespoke research assessments.
Equality, Diversity and Inclusion
Essential criteria
* Able to demonstrate a commitment and understanding of the importance of treating all individuals with dignity and respect appropriate to their individual needs.
Additional Information
Please submit your application form without delay to avoid disappointment; we will close vacancies prior to the publishing closing date if we receive a sufficient number of completed application forms. Please check the email account (including your junk mail) that you supplied as part of your application on a regular basis following the closing date and throughout the recruitment process, as this is how we will communicate with you. UHL is an equal opportunities employer. We aim to employ a workforce that reflects the diverse communities we serve. We welcome applications from people from all backgrounds who match our job criteria. Applicants who have a disability and meet the essential criteria for the job will be interviewed if you indicate you wish to be considered under the Guaranteed Interview Scheme. If you require a reasonable adjustment at any stage of the recruitment process please make the recruitment services team aware as soon as possible. UHL is committed to helping colleagues balance the demands of both their work and personal needs through flexible working arrangements wherever reasonably practicable and subject to service needs.
Disclosure and Barring Service Check
Please note if you are successful in obtaining this position and the post involves regulated activity you will be required to undertake a Disclosure & Barring Service check. The Trust will pay for the check initially and the money will then be deducted from your salary over a three month period commencing on your first month's payment. The current price of a check is £38 for an enhanced and £18 for a standard check.
COVID 19 Risk Assessment
Due to the current Covid pandemic we have introduced a staff risk assessment into our pre-employment process. This now forms part of the mandatory pre-employment checks that will be carried out if you receive a conditional offer. The risk assessment is intended to ensure you are able to safely perform your duties in any of our work areas, and if you have been identified as being particularly vulnerable to coronavirus. Our main aim is to reduce risk and to ensure the safety of all new starters to the Trust as well as current staff, patients and visitors. If it is identified that you are within a vulnerable category, we will endeavor to make reasonable adjustments to accommodate this through discussions with both Occupational Health and your recruiting manager.
Covid Vaccination Status
Covid-19 vaccination remains the best way to protect yourself, family, colleagues and our patients/service users from the Covid-19 virus. We therefore continue to encourage our current and potential colleagues to get vaccinated.
University Hospitals of Leicester NHS Trust holds the principles of equality, diversity and inclusion at the heart of everything it does and all that it stands for. We are committed to developing a workforce that is representative of the community we serve. We welcome applications from the diverse community of Leicester, Leicester and Rutland, to help deliver healthcare services that meets the needs of our diverse communities.
Employer certification / accreditation badges
Applicant requirements
This post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service.
Documents to download
* Job Description (PDF, 592.3KB)
* Understanding your right to work in the UK (PDF, 1.1MB)
* Employee Benefits (PDF, 578.5KB)
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