Job summary
An exciting and rare has become available within the Newcastle Joint Research Office (NJRO). The vacancy is maternity cover for the role of Regulatory Compliance Specialist. The post holder will work with a dynamic team ensuring Good Clinical Practice and regulatory compliance for research trials sponsored by The Newcastle upon Tyne Hospitals NHS Foundation Trust. As part of the NJRO there is opportunity to work closely with our partner, Newcastle University and also other organisations on a national scale. The role acts as a sponsor representative on behalf of Newcastle Hospitals and will work closely with Clinical Trials Units across the country. Applicants will need to have excellent interpersonal skills and attention to detail. Applicants should also be able to work under pressure and to tight deadlines within the restriction of clinical trials regulations. They will support process development, external vendors and manage a small team. For those looking to further their skills within the clinical research landscape, this position offers an excellent opportunity to be involved at a local and national level.
- Interview Date Tuesday, 17 September 2024
- 37 Hours 30 Minutes/Week
- You will be redirected to Trac to apply for the vacancy. Please expand the job details section and read all of the information before applying for the vacancy
Main duties of the job
- Review of applications to sponsor clinical trials
- Support regulatory compliance in-line with GCP requirements
- Provide support and oversight of contracted Clinical Trials Units
- Provide expert and specialist advice to colleagues
- Ensure process is followed and developed as applicable
- Support local Chief Investigators with trial set-up and management
- Support local and national R&D departments as required
- Provide training
- Support inspection readiness processes for Newcastle Hospitals
- Development of standard operating procedures
- Enable Newcastle Hospitals research strategy
- Sponsor representative for Newcastle Hospitals on a national and international scale
- Support the Regulatory Compliance Manager
- Support the wider functions and colleagues within Newcastle Joint Research Office
About us
Newcastle Hospitals NHS Foundation Trust is one of the busiest, largest and most successful teaching NHS foundation trusts in the country, with around 16,000 staff and an annual income of £1 billion.
We have a long history of providing high quality care, clinical excellence, and innovation in medical research regionally, nationally and internationally.
We're also proud to be the second largest provider of specialised services in the country. This means we support people with a range of rare and complex medical, surgical and neurological conditions, cancers and genetic orders.
Our staff oversee around 2 million patients 'contacts' each year, delivering high standards of healthcare.
Please see attached information on what Staff Benefits we have to offer at our Trust.
We are committed to promoting equality and diversity and recognise the benefit in providing an inclusive environment. We value and respect the diversity of our employees and aim to recruit a workforce which reflects the communities we serve, and is equipped to deliver the best service to our patients. We welcome all applications irrespective of people's race, disability, gender, sexual orientation, religion or belief, age, gender identity, marriage and civil partnership, pregnancy and maternity and in particular those from under- represented groups.
Job description
Job responsibilities
- As part of a wider team, the Regulatory Compliance Specialist will play a key role in co-ordinating the sponsor and/or HRA process by ensuring research is conducted in accordance with external and internal regulations, SOPs and policies.
- Evaluate studies to establish their suitability for Sponsorship under the UK Policy for Health Research Governance Framework for Health and Social Care, and ensure ongoing oversight of Sponsored studies.
- Working closely with the respective Regulatory Compliance Manager or Deputy Regulatory Compliance Manager to provide specialist support by ensuring sponsored research is appropriately risk assessed, fully funded, peer reviewed and based on realistic feasibilities
- Where appropriate, maintain robust systems to ensure adequate sponsor oversight of pharmacovigilance and safety aspects of sponsored Clinical Trials
- Responsible for maintaining and improving processes to ensure that sponsorship applications are processed efficiently, that Ethical, MHRA and HRA applications are robust, obtained in a timely manner, and that oversight is maintained throughout the life of the project to publication and archiving of the study data
- Responsible for providing direction and overseeing the quality of work of more junior team members
- To provide advice, support and guidance to Chief Investigators, Principal Investigators and the research delivery teams in relation to research governance responsibilities and ensure compliance with legislative frameworks
- Responsibility for maintaining and archiving of Sponsor Trial Master Files in accordance with SOPs and Regulation
- Work collaboratively with wider NJRO Team, providing support where required
As a flexible working friendly organisation, we want to be sure that you can work in a way that is best for us and for our patients, and for you. Speak to us about how we might be able to accommodate a flexible working arrangement. If it works for the service, we will do our best to make it work for you.
Please note it is a requirement of The Newcastle upon Tyne Hospitals NHS Foundation Trust that all successful candidates who require a DBS for the post they have been offered pay for their DBS certificate. The method of payment is a salary deduction from your first months pay.
Job description
Job responsibilities
- As part of a wider team, the Regulatory Compliance Specialist will play a key role in co-ordinating the sponsor and/or HRA process by ensuring research is conducted in accordance with external and internal regulations, SOPs and policies.
- Evaluate studies to establish their suitability for Sponsorship under the UK Policy for Health Research Governance Framework for Health and Social Care, and ensure ongoing oversight of Sponsored studies.
- Working closely with the respective Regulatory Compliance Manager or Deputy Regulatory Compliance Manager to provide specialist support by ensuring sponsored research is appropriately risk assessed, fully funded, peer reviewed and based on realistic feasibilities
- Where appropriate, maintain robust systems to ensure adequate sponsor oversight of pharmacovigilance and safety aspects of sponsored Clinical Trials
- Responsible for maintaining and improving processes to ensure that sponsorship applications are processed efficiently, that Ethical, MHRA and HRA applications are robust, obtained in a timely manner, and that oversight is maintained throughout the life of the project to publication and archiving of the study data
- Responsible for providing direction and overseeing the quality of work of more junior team members
- To provide advice, support and guidance to Chief Investigators, Principal Investigators and the research delivery teams in relation to research governance responsibilities and ensure compliance with legislative frameworks
- Responsibility for maintaining and archiving of Sponsor Trial Master Files in accordance with SOPs and Regulation
- Work collaboratively with wider NJRO Team, providing support where required
As a flexible working friendly organisation, we want to be sure that you can work in a way that is best for us and for our patients, and for you. Speak to us about how we might be able to accommodate a flexible working arrangement. If it works for the service, we will do our best to make it work for you.
Please note it is a requirement of The Newcastle upon Tyne Hospitals NHS Foundation Trust that all successful candidates who require a DBS for the post they have been offered pay for their DBS certificate. The method of payment is a salary deduction from your first months pay.
Person Specification
Skill
Essential
- Educated to degree level or equivalent qualification and/or experience of working in clinical research
- Advanced knowledge and expertise (to post graduate level equivalent) of sponsor, safety and/or HRA related issues in a variety of types of clinical trials and research studies
- Advanced knowledge and expertise regarding the laws, guidelines and frameworks which govern the set up and conduct of clinical research within the UK (includes, but not limited to: Statutory Instruments; Good Clinical Practice (GCP); applicable Frameworks; EU Directive; Health Research Authority (HRA))
- Advanced knowledge of terminology used in clinical research
- Advanced organisational skills and ability to oversee multiple projects at various stages of development
Desirable
- A thorough understanding of research-related processes, particularly within the NHS
- Experience of producing high quality documents e.g. SOPs
- Excellent interpersonal skills in dealing with a diverse range of staff
- Ability to problem solve/make decisions
Personality / Potential
Essential
- Advanced organisational skills and ability to oversee multiple projects at various stages of development.
- Excellent interpersonal, communication (both written and verbal) and leadership skills and ability to facilitate collaborative working relationships
- Self-directed and ability to meet deadlines
- To promote team working in all aspects of work, which will in turn contribute to the health and well-being of the workforce
- Ability to lead on all aspects of the research approval process
- Strong organisational skills and clear self-motivation
- Strong understanding of risk management issues
- Adaptable/flexible approach to work
- Excellent written and oral communication skills, including presentations
- Advanced IT skills, specifically in use of Microsoft Office Applications, to underpin the ability to create and/or develop reporting tools
Desirable
- Ability to demonstrate team approach
Experience
Essential
- Specialist knowledge and experience of the laws, guidelines and frameworks which govern the set up and conduct of clinical research within the UK
- Knowledge and understanding of Trust confidentiality policies and procedures (includes, but not limited to: Data Protection Act; Caldicott Guidelines.)
- Ability to communicate effectively, written and verbally, with colleagues and with stakeholders both internal and external to the Trust
- Ability to prioritise, distribute and manage an increasing workload between themselves and the admin team
- Understanding of the sensitivities, needs and requirements of individual organisations, research teams and colleagues
Attitude / Aptitude
Essential
- Adaptable/flexible approach to work
- Excellent interpersonal, communication and leadership skills and ability to facilitate collaborative working relationships
- A motivated and enthusiastic approach with the commitment to providing a professional service
Desirable
- Ability to contribute to a team approach
Knowledge
Essential
- Educated to degree level or equivalent higher level qualification or equivalent professional experience
- Advanced knowledge and expertise (to post graduate level equivalent) of sponsor, safety and/or HRA related issues in a variety of types of clinical trials and research studies
- Advanced knowledge and expertise regarding the laws, guidelines and frameworks which govern the set up and conduct of clinical research within the UK (includes, but not limited to: Statutory Instruments; Good Clinical Practice (GCP); Research Governance Framework; EU Directive; Health Research Authority (HRA))
- Advanced knowledge of terminology used in clinical research
- An awareness of the national health research strategy within the NHS
Desirable
- A thorough understanding of health research issues, particularly within the NHS
Person Specification
Skill
Essential
- Educated to degree level or equivalent qualification and/or experience of working in clinical research
- Advanced knowledge and expertise (to post graduate level equivalent) of sponsor, safety and/or HRA related issues in a variety of types of clinical trials and research studies
- Advanced knowledge and expertise regarding the laws, guidelines and frameworks which govern the set up and conduct of clinical research within the UK (includes, but not limited to: Statutory Instruments; Good Clinical Practice (GCP); applicable Frameworks; EU Directive; Health Research Authority (HRA))
- Advanced knowledge of terminology used in clinical research
- Advanced organisational skills and ability to oversee multiple projects at various stages of development
Desirable
- A thorough understanding of research-related processes, particularly within the NHS
- Experience of producing high quality documents e.g. SOPs
- Excellent interpersonal skills in dealing with a diverse range of staff
- Ability to problem solve/make decisions
Personality / Potential
Essential
- Advanced organisational skills and ability to oversee multiple projects at various stages of development.
- Excellent interpersonal, communication (both written and verbal) and leadership skills and ability to facilitate collaborative working relationships
- Self-directed and ability to meet deadlines
- To promote team working in all aspects of work, which will in turn contribute to the health and well-being of the workforce
- Ability to lead on all aspects of the research approval process
- Strong organisational skills and clear self-motivation
- Strong understanding of risk management issues
- Adaptable/flexible approach to work
- Excellent written and oral communication skills, including presentations
- Advanced IT skills, specifically in use of Microsoft Office Applications, to underpin the ability to create and/or develop reporting tools
Desirable
- Ability to demonstrate team approach
Experience
Essential
- Specialist knowledge and experience of the laws, guidelines and frameworks which govern the set up and conduct of clinical research within the UK
- Knowledge and understanding of Trust confidentiality policies and procedures (includes, but not limited to: Data Protection Act; Caldicott Guidelines.)
- Ability to communicate effectively, written and verbally, with colleagues and with stakeholders both internal and external to the Trust
- Ability to prioritise, distribute and manage an increasing workload between themselves and the admin team
- Understanding of the sensitivities, needs and requirements of individual organisations, research teams and colleagues
Attitude / Aptitude
Essential
- Adaptable/flexible approach to work
- Excellent interpersonal, communication and leadership skills and ability to facilitate collaborative working relationships
- A motivated and enthusiastic approach with the commitment to providing a professional service
Desirable
- Ability to contribute to a team approach
Knowledge
Essential
- Educated to degree level or equivalent higher level qualification or equivalent professional experience
- Advanced knowledge and expertise (to post graduate level equivalent) of sponsor, safety and/or HRA related issues in a variety of types of clinical trials and research studies
- Advanced knowledge and expertise regarding the laws, guidelines and frameworks which govern the set up and conduct of clinical research within the UK (includes, but not limited to: Statutory Instruments; Good Clinical Practice (GCP); Research Governance Framework; EU Directive; Health Research Authority (HRA))
- Advanced knowledge of terminology used in clinical research
- An awareness of the national health research strategy within the NHS
Desirable
- A thorough understanding of health research issues, particularly within the NHS
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).
