Job summary
North Bristol Trust is seeking to recruit to an important and exciting role within Research & Development department as a Clinical Trials Officer Band 6.
The clinical trials officer role sits within our sponsorship team, whose function is to have oversight for all NBT sponsored research studies.
The role will involve conducting appropriate risk assessments and identifying risk mitigations of proposed research studies. The post holder will provide ongoing support to researchers in preparation for HRA submissions and will also be responsible for maintaining ongoing oversight of the study throughout its delivery.
In the role you will promote and develop a research culture that supports high quality research by helping and supporting research leaders and their teams.
We are looking for someone who has relevant experience of managing research within healthcare settings with up-to-date knowledge and understanding of local and UK regulatory requirements relating to research, as well as someone who enjoys collaborating and providing support to a variety of different people. You will need to be a good communicator and be diligent, showing attention to detail, whilst being a proactive problem solver. If you think this is you and you are looking for a new challenge working as part of a friendly team then please get in touch to find out more and have an informal chat about the role.
Main duties of the job
The post holder is required to provide support to the Research Compliance Manager to implement systems and standard operating procedures to support and monitor clinical research studies within the organisation in line with the current UK Policy Framework for Health and Social Care, the Medicines for Human Use (Clinical Trials) Regulations (2004), ISO 14155 and any subsequent amendments and ICH - GCP regulations.
The post holder will be responsible for ensuring appropriate assessment of the risks to NBT when acting as sponsor for research studies.
The post holder will be responsible for monitoring the quality of research, by attending regular meetings with the research team and conducting risk-based monitoring visits.
The Clinical Trials Officer (CTO) will need to monitor the data produced, as well as participant safety and experience.
The CTO will be responsible for facilitating trial set-up, by supporting the research facilitation team and wider teams to ensure efficient set up whilst meeting required standards and regulatory requirements.
The CTO will be responsible for the quality of data maintained within R&D database.
The CTO will act as a resource regarding study delivery, SOP development, Pharmacovigilance, and training.
The CTO will be expected to work in a team and resolve complex issues around research collaboration, material and data transfer and handling of samples as per the guidelines provided by the framework of health and social care.
About us
The role is based within the successful & welcoming Research & Development (R&D) team at North Bristol NHS Trust. Working alongside the 170 plus departmental staff you will have the opportunity to network with other researchers and have access to our supportive training and development structure. The R&D team have been awarded the Investors in People Silver Award (2022-2025), making it a great place to work.
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.
We commit to treating each patient as an individual with respect and dignity, aiming to deliver excellent clinical outcomes and a first-class experience for everyone who uses our services.
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
Please review the job descrition for more detailed information regarding main responsibilities:
Ares of key responsibilities relate to the following areas:
Clinical trial set up and running
Reviewing research proposals and associated study documentation, appraise risk and undertake sposnorship review on behalf of NBT. Working with stakeholders to ensure all governance and regulatory checks have been carried out prior to R&D approvals.
Overseeing study delivery and ensure research compliance and reporting is adhered to
Performance management.
Oversee performance of NBT sponsored studeies working with stakeholders to identify and address poor recruitment.
Be responsible for fulfulling the trust monitoring obligations in line with the Reesarch Governance Framework and Clinica Trials Regulations
To be responsible for identifying corrective and preventative action and ensuring this is implemented to address the findings of study monitoring activities.
Compile safety monitoring data for MHRA, regulatory authorities, the Trust board and for R&D internal review
Other
Accountable for own actions in accordance with appropriate Code of Professional Conduct, Trust policies and procedures
Maintain responsibility for own professional and specialist development
Responsible for the quality of data maintained within R&D pertaining to studies registered on the R&D IT system, currently EDGE
Assist Research Compliance Manager in developing, implementing, and maintaining a networked approach as a local response to national developments in Research and Development
Job description
Job responsibilities
Please review the job descrition for more detailed information regarding main responsibilities:
Ares of key responsibilities relate to the following areas:
Clinical trial set up and running
Reviewing research proposals and associated study documentation, appraise risk and undertake sposnorship review on behalf of NBT. Working with stakeholders to ensure all governance and regulatory checks have been carried out prior to R&D approvals.
Overseeing study delivery and ensure research compliance and reporting is adhered to
Performance management.
Oversee performance of NBT sponsored studeies working with stakeholders to identify and address poor recruitment.
Be responsible for fulfulling the trust monitoring obligations in line with the Reesarch Governance Framework and Clinica Trials Regulations
To be responsible for identifying corrective and preventative action and ensuring this is implemented to address the findings of study monitoring activities.
Compile safety monitoring data for MHRA, regulatory authorities, the Trust board and for R&D internal review
Other
Accountable for own actions in accordance with appropriate Code of Professional Conduct, Trust policies and procedures
Maintain responsibility for own professional and specialist development
Responsible for the quality of data maintained within R&D pertaining to studies registered on the R&D IT system, currently EDGE
Assist Research Compliance Manager in developing, implementing, and maintaining a networked approach as a local response to national developments in Research and Development
Person Specification
Education/Training/Qualifications
Essential
- Graduate qualification (e.g. BSc) in social sciences/research or management or equivalent Experience
- ICH - GCP (inc. UK statutory instruments)
- Evidence of continuing professional development
Work Experience
Essential
- Recent NHS / UK Clinical Trial and/or other clinical research experience
- Significant, recent, and demonstrable UK / NHS research management experience
- Proven project management abilities
- Experience of working as part of a team for a significant proportion of relevant work experience
Desirable
- Experience of conducting or participating in UK / NHS research risk assessments
- Experience in NHS / UK clinical trials regulatory inspections / monitoring / audit
Knwoledge/Skills/Abilities
Essential
- Good understanding, and significant practical experience of the implications of the UK policy Framework for Health and Social Care, Research Governance and regulatory research requirements within the NHS and its application
- Up to date knowledge and understanding of local, national and international regulatory requirements relating to research
- Excellent communication skills - with an ability to demonstrate an ability to negotiate, and form and maintain good relationships with peers, colleagues in difficult circumstances
- Good analytical skills: able to digest, analyse, interpret and communicate complex information
- A good working knowledge of the full range of Microsoft Office 360 applications (Word, PowerPoint, Access, Excel, Publisher).
Personal Qualities/Special Circumstances
Essential
- Effective interpersonal and influencing skills
- Ability to be mobile to meet the demands of the post- this post may involve travel to external sites to monitor, where required
- Ability to proactively problem solve
- Ability to establish and maintain collaborative relationships.
Person Specification
Education/Training/Qualifications
Essential
- Graduate qualification (e.g. BSc) in social sciences/research or management or equivalent Experience
- ICH - GCP (inc. UK statutory instruments)
- Evidence of continuing professional development
Work Experience
Essential
- Recent NHS / UK Clinical Trial and/or other clinical research experience
- Significant, recent, and demonstrable UK / NHS research management experience
- Proven project management abilities
- Experience of working as part of a team for a significant proportion of relevant work experience
Desirable
- Experience of conducting or participating in UK / NHS research risk assessments
- Experience in NHS / UK clinical trials regulatory inspections / monitoring / audit
Knwoledge/Skills/Abilities
Essential
- Good understanding, and significant practical experience of the implications of the UK policy Framework for Health and Social Care, Research Governance and regulatory research requirements within the NHS and its application
- Up to date knowledge and understanding of local, national and international regulatory requirements relating to research
- Excellent communication skills - with an ability to demonstrate an ability to negotiate, and form and maintain good relationships with peers, colleagues in difficult circumstances
- Good analytical skills: able to digest, analyse, interpret and communicate complex information
- A good working knowledge of the full range of Microsoft Office 360 applications (Word, PowerPoint, Access, Excel, Publisher).
Personal Qualities/Special Circumstances
Essential
- Effective interpersonal and influencing skills
- Ability to be mobile to meet the demands of the post- this post may involve travel to external sites to monitor, where required
- Ability to proactively problem solve
- Ability to establish and maintain collaborative relationships.
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).
