Job summary
This is a unique and exciting opportunity for an experienced clinical assistant with administrative skills to join the Research & Innovation (R&I) research workforce at University Hospitals of Leicester.
To provide research support for individual trials being conducted within the network region. This involves working on more than one project at any time and in more than one clinical speciality as appropriate.
To ensure that training pertinent to role is up to date e.g. GCP-ICH, informed consent as well as mandatory training as required by individual trusts. Attend training to maintain clinical skills as appropriate
To be flexible in their approach to work as the role may require flexibility in terms of timing e.g. for specific treatments
To be accountable for all tasks within their scope of practice and to be aware of their own development needs/limitations, while providing support to others.
To work through a competency based framework to enable to post holder to attain the skills of a competent research practitioner.
Main duties of the job
Have an understanding of the application of ICH GCP Guidelines, the EU Directive on Clinical Research and Research Governance.? 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 follow up as part of research projects. Process 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 medical notes for 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. Ensure safe and appropriate storage of specimens, in accordance with the trial protocol and in conjunction with specialist teams. Record and report any adverse events and serious adverse events according to trial protocol and local procedures
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 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:
http://www.leicestershospitals.nhs.uk/aboutus/work-for-us/current-vacancies/
The detailed job description and main responsibilities are included as an attachment to this advert.
Job description
Job responsibilities
Under supervision the research practitioner will:
Have an understanding of the application of ICH GCP Guidelines, the EU Directive on Clinical Research and Research Governance.
Identify patients suitable for entry into clinical trials and research studies. This may include attending clinics and multidisciplinary team meetings, reviewing medical notes and inclusion/exclusion criteria.
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 follow up as part of research projects.
Process 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 medical notes for 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
Ensure safe and appropriate storage of specimens, in accordance with the trial protocol and in conjunction with specialist teams
Record and report any adverse events and serious adverse events according to trial protocol and local procedures
Job description
Job responsibilities
Under supervision the research practitioner will:
Have an understanding of the application of ICH GCP Guidelines, the EU Directive on Clinical Research and Research Governance.
Identify patients suitable for entry into clinical trials and research studies. This may include attending clinics and multidisciplinary team meetings, reviewing medical notes and inclusion/exclusion criteria.
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 follow up as part of research projects.
Process 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 medical notes for 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
Ensure safe and appropriate storage of specimens, in accordance with the trial protocol and in conjunction with specialist teams
Record and report any adverse events and serious adverse events according to trial protocol and local procedures
Person Specification
Essential
Essential
- 2 years research experience
Desirable
- Cancer knowledge and experience
Desirable
Desirable
Desirable
Desirable
- Able to interpret and transcribe data
Person Specification
Essential
Essential
- 2 years research experience
Desirable
- Cancer knowledge and experience
Desirable
Desirable
Desirable
Desirable
- Able to interpret and transcribe data
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).
