Job summary
Are you an individual who is organised, has an eye for detail and likes to work in a team? If so, you may be the person we are looking for.
The Research & Development Trial Management Unit are seeking an individual who can provide efficient and effective clinical trial coordination, organisation and data management support, for local and multi-centre clinical research trials.
Previous clinical trial coordination or project management experience would be desirable but is not essential for this post. Relevant training will be given to the successful candidate.
This post offers the potential to progress to a Band 5 position on successful completion of core research competencies, relevant training and successful demonstration of required skills and knowledge (usually within 18-24 months).
Please be advised there is a proposed interview date of 27th April 2023.
Main duties of the job
The role will involve the day-to-day coordination of clinical research trials with a dedicated research team, including preparing study documentation, ethics applications and reports, setting up study databases, monitoring data quality and study progress at participating sites, to ensure compliance with the study protocol and recruitment targets are met. As well as communicating with researchers and clinical staff, organising trial meetings and undertaking general administrative tasks. For the right candidate this post offers the opportunity to work in a busy team, gain new skills and knowledge and make a real contribution to improving patientoutcomes through research.
To be successful in this post you will need to be able to demonstrate that you have relevant experience in clinical research and data management. You should be an excellent communicator who is able to display initiative, efficient time management, the ability to prioritise workload activities, have a keen eye for detail and possess good literacy and IT skills.
About us
University Hospitals Coventry and Warwickshire NHS Trust, rated as good by the Care Quality Commission, is one of the largest teaching Trusts in the UK.
We are extremely proud of our employees across our hospital sites, with high quality patient care at the heart of everything we do.
Boasting some of the most modern facilities in Western Europe, the Trust is renowned for being at the forefront of research and innovation as part of its blossoming reputation as a worldwide leader in healthcare.
We are proud to be recognised as a Pathway to Excellence designated organisation - please click the link for further details about this prestigious award. Pathway To Excellence - University Hospitals Coventry & Warwickshire (uhcw.nhs.uk)
By joining our exciting journey, you will form part of a passionate, talented team and will be able to access a wide range of learning and development opportunities. There has never been a better time to join our team.
The Trust is committed to building an organisation that makes full use of the talents, skills, experience, and different perspectives available in our diverse society. We want everyone to feel they are respected, valued, can achieve their potential and receive the most appropriate and relevant care. We will create an environment where the equality and human rights principles of fairness, respect, equality, dignity and autonomy are promoted and are part of the organisation's core values.
Job description
Job responsibilities
Responsibility for the day-to-day coordination of selected non-commercial studies with support from the Trial Manager, including providing support to researchers with their ethics applications. Initiation of studies at participating sites, including obtaining NHS permissions, coordinating signing of contracts and arranging and conducting site initiation meetings, ensuring all necessary documentation is in place prior to commencement of the study. Monitoring compliance of studies with GCP principles, research governance and relevant legislation. Monitoring study progress at participating sites to ensure compliance with the study protocol and recruitment targets are met. Providing regular reports on study progress to the Trial Manager and Lead Investigators/study management teams. Managing the procurement and supply of study consumables and ensuring auditable records are maintained.
- Coordinating the processing of study invoices and ensuring accurate and up-to-date records are kept. Co-ordinating and providing administrative support for study meetings. Delegated responsibility for maintaining study Trial Master Files in line with ICH GCP guidelines. Assisting in preparing and maintaining study documentation and ensuring new versions of documents are implemented at sites. Facilitating the secure storage and archiving of study documentation in accordance with ICH GCP and Research Governance. Implementation and maintenance of efficient filing systems. Coordinating the production of study reports and publications. Coordinating study closure in line with Trust policies and Research Ethics Committee (REC) requirement.
Please see job description attached for further information
Job description
Job responsibilities
Responsibility for the day-to-day coordination of selected non-commercial studies with support from the Trial Manager, including providing support to researchers with their ethics applications. Initiation of studies at participating sites, including obtaining NHS permissions, coordinating signing of contracts and arranging and conducting site initiation meetings, ensuring all necessary documentation is in place prior to commencement of the study. Monitoring compliance of studies with GCP principles, research governance and relevant legislation. Monitoring study progress at participating sites to ensure compliance with the study protocol and recruitment targets are met. Providing regular reports on study progress to the Trial Manager and Lead Investigators/study management teams. Managing the procurement and supply of study consumables and ensuring auditable records are maintained.
- Coordinating the processing of study invoices and ensuring accurate and up-to-date records are kept. Co-ordinating and providing administrative support for study meetings. Delegated responsibility for maintaining study Trial Master Files in line with ICH GCP guidelines. Assisting in preparing and maintaining study documentation and ensuring new versions of documents are implemented at sites. Facilitating the secure storage and archiving of study documentation in accordance with ICH GCP and Research Governance. Implementation and maintenance of efficient filing systems. Coordinating the production of study reports and publications. Coordinating study closure in line with Trust policies and Research Ethics Committee (REC) requirement.
Please see job description attached for further information
Person Specification
Qualifications
Essential
- Meets all essential criteria
Desirable
- Meets all desirable criteria
Experience
Essential
- Meets all essential criteria
Desirable
- Meets all desirable criteria
Knowledge
Essential
- Meets all essential criteria
Skills
Essential
- Meets all essential criteria
Person Specification
Qualifications
Essential
- Meets all essential criteria
Desirable
- Meets all desirable criteria
Experience
Essential
- Meets all essential criteria
Desirable
- Meets all desirable criteria
Knowledge
Essential
- Meets all essential criteria
Skills
Essential
- Meets all essential criteria
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).
