Employer University Hospitals of Leicester NHS Trust Location Leicester, United Kingdom Salary Competitive Closing date 3 May 2025
Detailed job description and main responsibilities
* To assist with the acquisition and distribution of relevant trial documentation.
* 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.
* To assist in the preparation and submission of documentation for clinical research approvals.
* To create and maintain 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 form (CRF) and to liaise with clinical trials coordinators, research nurses and investigators to ensure accurate data collection.
* To transcribe/export data from medical records (paper or electronic) to CRFs (paper or electronic e-CRFs) as required by the study protocol.
* To ensure safe filing and storage of study documentation in accordance to research governance.
* Conduct quality assurance of documentation.
* To organise and prepare for visits by trial monitors as required by the study protocol.
* To take responsibility for liaising with clinical trial units regarding data queries and for checking and resolving data queries.
* To support the assessment of 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.
* To provide written and verbal information relevant to the research study and support clinical staff in the process of gaining informed consent from participants that are entering into clinical research.
* To deal with telephone enquiries from staff, patients and relatives, ensuring that appropriate personnel are informed in order for actions to be taken.
* To report any adverse events to the appropriate research nurse and/or principal investigator (PI).
* Presenting specific trial information at multidisciplinary team meetings.
* To act in a professional manner at all times when dealing with patients, relatives and representatives from both within and outside of the Trust.
* Co-ordination of specified trials and take responsibility for :
o Organisation of any necessary tests and investigations as detailed within the
o Sample preparation (e.g. blood, urine, tissue and faecal samples): retrieval, centrifuging, pipetting, slide making and preparation for storage, liaising with the hospital and external laboratories when appropriate.
o Undertaking low risk clinical duties.
o Maintaining logs of stored samples and freezer temperatures.
o Maintaining adequate stock levels of sample kits.
o Required to hold a phone for a short period of time to monitor freezer/fridge temperatures including during and out of office hours.
o Organising the logistical aspects of diagnostic specimens, packaging, and shipment, including handling of dry ice.
o Resolving data queries raised by sponsoring organisations.
o Archiving all study related material including patient's notes after study closure.
o Reporting and submitting of Serious Adverse Events (SAEs) from this site within stipulated timeframes to sponsor organisations and the Research and Innovation Office.
o Tracking Serious Unexpected Event reporting.
o Maintaining and updating study specific site files.
o Notifying General Practitioners of their patient's involvement in a clinical trial.
* 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
* Educated to GCSE standard or equivalent, including English and Maths
* Awareness of the importance of data confidentiality
Desirable criteria
* Evidence of further education/development
* GCP training and/or research experience
Communication and relationship skills
Essential criteria
* Excellent communication and interpersonal skills at all levels, both written and verbal
* Ability to work independently and as part of a small research team
Experience
Essential criteria
* Administration experience
* Competent in IT systems (Word, Excel and other Microsoft Office applications)
Desirable criteria
* Experience using research databases
* Experience preparing, handling and processing biological samples
* Experience working in an NHS environment
Planning and organisation skills
Essential criteria
* Ability to work on own with minimal supervision and able to use initiative
* Able to work flexibly as and when required
* Ability to manage time effectively, prioritise work and to deliver results consistently to deadlines
* Proven organisation skills
Desirable criteria
* Able to adapt and work across various specialities
Equality & Diversity
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
Analytic and judgement skills
Essential criteria
* High attention to detail in data collection and inputting
* Ability to problem solve
Commitment to Trust Values and Behaviours
Essential criteria
* Must be able to demonstrate behaviours consistent with the Trust's Values and Behaviours
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
* JD/PS (PDF, 470.4KB)
* Understanding your right to work in the UK (PDF, 1.1MB)
* Employee Benefits (PDF, 578.5KB)
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