Job summary
This is a unique and exciting opportunity to join the Research & Innovation (R&I) workforce at University Hospitals of Leicester (UHL).
This is a great opportunity to become a member of the HOPE cancer trials team. We have an ever changing diverse portfolio of clinical haematology and oncology trials including those exploring compounds at the early stages of development. We offer a commitment to support training and professional development needs and the opportunity to develop interests and skills in the prevention, diagnosis and treatment of cancer.
There are close relationships between the Biomedical Research Centre (BRC) Themes, University of Leicester and UHL clinical areas across the 3 sites. Funding from the Clinical Research Network (CRN) will support the delivery of research programmes across all specialties at UHL.
Main duties of the job
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 support in clinical trials such as preparing, handling and processing biological samples, and data management and resolution, in accordance with the clinical trial protocol and Good Clinical Practice (GCP). To ensure compliance with UHL policies on data protection, confidentiality and security.
The post holder will provide the highest standards of patient care in line with research protocols and ICH Good Clinical Practice guidelines, safeguarding the well-being and safety of the patients and integrity of the data.
To work alongside Principal Investigators and the research team to assist in the delivery of a high quality research service of clinical expertise, professional advice, support, guidance and education to the multi-professional team, patients and carers within the research service.
The post-holder will ensure the highest standard is delivered to research subjects and, where relevant to their families, in partnership with all members of the multi professional and research teams.
About us
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
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/
Job description
Job 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 arrangingappropriate 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 :
- Organisation of any necessary tests and investigations as detailed within the
- 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.
- Undertaking low risk clinical duties.
- Maintaining logs of stored samples and freezer temperatures.
- Maintaining adequate stock levels of sample kits.
- Required to hold a phone for a short period of time to monitor freezer/fridge temperatures including during and out of office hours.
- Organising the logistical aspects of diagnostic specimens, packaging, and shipment, including handling of dry ice.
- Resolving data queries raised by sponsoring organisations.
- Archiving all study related material including patients notes after study closure.
- Reporting and submitting of Serious Adverse Events (SAEs) from this site within stipulated timeframes to sponsor organisations and the Research and Innovation Office.
- Tracking Serious Unexpected Event reporting.
- Maintaining and updating study specific site files.
- Notifying General Practitioners of their patients 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.
Job description
Job 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 arrangingappropriate 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 :
- Organisation of any necessary tests and investigations as detailed within the
- 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.
- Undertaking low risk clinical duties.
- Maintaining logs of stored samples and freezer temperatures.
- Maintaining adequate stock levels of sample kits.
- Required to hold a phone for a short period of time to monitor freezer/fridge temperatures including during and out of office hours.
- Organising the logistical aspects of diagnostic specimens, packaging, and shipment, including handling of dry ice.
- Resolving data queries raised by sponsoring organisations.
- Archiving all study related material including patients notes after study closure.
- Reporting and submitting of Serious Adverse Events (SAEs) from this site within stipulated timeframes to sponsor organisations and the Research and Innovation Office.
- Tracking Serious Unexpected Event reporting.
- Maintaining and updating study specific site files.
- Notifying General Practitioners of their patients 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
- Educated to GCSE standard or equivalent, including English and Maths
- Awareness of the importance of data confidentiality
Desirable
- Evidence of further education/development
- GCP training and/or research experience
Communication and relationship skills
Essential
- 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
- Administration experience
- Competent in IT systems (Word, Excel and other Microsoft Office applications)
Desirable
- Experience using research databases
- Experience preparing, handling and processing biological samples
- Experience working in an NHS environment
Planning and organisation skills
Essential
- 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
- Able to adapt and work across various specialities
Equality & Diversity
Essential
- 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
- High attention to detail in data collection and inputting
- Ability to problem solve
Commitment to Trust Values and Behaviours
Essential
- Must be able to demonstrate behaviours consistent with the Trust's Values and Behaviours
Person Specification
Training & Qualifications
Essential
- Educated to GCSE standard or equivalent, including English and Maths
- Awareness of the importance of data confidentiality
Desirable
- Evidence of further education/development
- GCP training and/or research experience
Communication and relationship skills
Essential
- 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
- Administration experience
- Competent in IT systems (Word, Excel and other Microsoft Office applications)
Desirable
- Experience using research databases
- Experience preparing, handling and processing biological samples
- Experience working in an NHS environment
Planning and organisation skills
Essential
- 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
- Able to adapt and work across various specialities
Equality & Diversity
Essential
- 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
- High attention to detail in data collection and inputting
- Ability to problem solve
Commitment to Trust Values and Behaviours
Essential
- Must be able to demonstrate behaviours consistent with the Trust's Values and Behaviours
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Additional information
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
