Job summary
Applications are invited for the post of Clinical Trials Manager in the the Academic Respiratory Unit. The unit spans across both North Bristol NHS Trust and the University of Bristol and is based in the Learning & Research building at Southmead Hospital. We design, lead and deliver research into a wide range of respiratory conditions, with a particular focus onclinical studies and trials. Our unit has particular interests in pleural disease, airways diseases such as asthma and COPD, and interstitial lungdisease. Our Unit's objective is to play a positive role in advancing the understanding and treatment of lung disease for people everywhere.
The post holder will be funded to work with the Chief Investigator, Research Manager and other clinical and non-clinical academics within the ARU to ensure that the clinical trials that are assigned to them are delivered to time and target; within budget; and conducted in compliance with regulatory requirements, good clinical practice (GCP), and the study protocol.
Main duties of the job
To lead clinical trial project management for designated trials within the ARU including development, set up and approvals, monitoring of progress, quality and compliance, dissemination and close out.
About us
North Bristol NHS Trust employs over 12,000 staff providing healthcare to the residents of Bristol, South Gloucestershire and North Somerset from our award-winning hospital building at Southmead. We are the regional Major Trauma Centre, and an internationally recognised centre of excellence in a range of services and major specialities. Our vision is that by enabling our teams to be the best that they can be, we will provide exceptional healthcare, personally delivered.
North Bristol NHS Trust values all people as individuals. We aim to be an anti-discriminatory organisation and are committed to building a team that represents a variety of backgrounds, perspectives, and skills. We welcome applicants from all underrepresented groups.
Job description
Job responsibilities
This role is central to the development and delivery of specific NIHR Portfolio trials carried out and sponsored by North Bristol NHS Trust. The post holder will be responsible for the set up, delivery and close down of specific studies adopted onto the NIHR portfolio, in accordance with local, national and international legislation. It will be the post holders responsibility to ensure studies are delivered in line with agreed targets with R&D, including financial planning. Their research knowledge and project management skills will ensure a well informed, coordinated support mechanism is provided to researchers and clinicians in the research team.
Please see attached job description and person specification for full details.
Job description
Job responsibilities
This role is central to the development and delivery of specific NIHR Portfolio trials carried out and sponsored by North Bristol NHS Trust. The post holder will be responsible for the set up, delivery and close down of specific studies adopted onto the NIHR portfolio, in accordance with local, national and international legislation. It will be the post holders responsibility to ensure studies are delivered in line with agreed targets with R&D, including financial planning. Their research knowledge and project management skills will ensure a well informed, coordinated support mechanism is provided to researchers and clinicians in the research team.
Please see attached job description and person specification for full details.
Person Specification
Education/Training/Qualifications
Essential
- BSc / BA in science/pharmacy/nursing/social sciences/research or management or equivalent
Knowledge/Skills/Abilities
Essential
- Evidence of financial and target management for delivery of clinical trials
- Evidence of managing data management and compliance challenges
Education/Training/Qualifications
Essential
- Significant experience working in a research environment
- Knowledge and experience of risk assessments for clinical trials
Work Experience
Essential
- Experience completing IRAS documentation and conducting all aspects of study set up
- Evidence of advanced organisational and project management skills
- Experience monitoring and auditing studies to ensure they comply with all relevant legislation
- Ability to work across both NHS and non-NHS organisations
- Experience of MHRA inspection
Knowledge/Skills/Abilities
Essential
- Advanced communication skills, verbal & written, to include report writing and record keeping
- Advanced knowledge of ICH-GCP (Inc UK Statutory Instruments)
- Understanding of the application of research within clinical and research governance
- Facilitation of development of other staff
Personal Qualities/Special Circumstances
Essential
- Evidence of continuing professional development
Desirable
- Ability to be mobile to meet the demands of the post
Knowledge/Skills/Abilities
Desirable
- Demonstrates an appreciation of how the Trust Organisational Objectives are underpinned by research
Personal Qualities/Special Circumstances
Essential
- Demonstrates an ability to work autonomously while co-ordinating multiple projects
Person Specification
Education/Training/Qualifications
Essential
- BSc / BA in science/pharmacy/nursing/social sciences/research or management or equivalent
Knowledge/Skills/Abilities
Essential
- Evidence of financial and target management for delivery of clinical trials
- Evidence of managing data management and compliance challenges
Education/Training/Qualifications
Essential
- Significant experience working in a research environment
- Knowledge and experience of risk assessments for clinical trials
Work Experience
Essential
- Experience completing IRAS documentation and conducting all aspects of study set up
- Evidence of advanced organisational and project management skills
- Experience monitoring and auditing studies to ensure they comply with all relevant legislation
- Ability to work across both NHS and non-NHS organisations
- Experience of MHRA inspection
Knowledge/Skills/Abilities
Essential
- Advanced communication skills, verbal & written, to include report writing and record keeping
- Advanced knowledge of ICH-GCP (Inc UK Statutory Instruments)
- Understanding of the application of research within clinical and research governance
- Facilitation of development of other staff
Personal Qualities/Special Circumstances
Essential
- Evidence of continuing professional development
Desirable
- Ability to be mobile to meet the demands of the post
Knowledge/Skills/Abilities
Desirable
- Demonstrates an appreciation of how the Trust Organisational Objectives are underpinned by research
Personal Qualities/Special Circumstances
Essential
- Demonstrates an ability to work autonomously while co-ordinating multiple projects
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).
