Job summary
Guy's and St Thomas' NHS Foundation Trust Research and Development Department are recruiting for a Research Governance Specialist. This is an exciting opportunity to join a dynamic R&D non-commercial team.
The post-holder will be working alongside our other highly valued Research Governance Specialists, and together will line manage a diverse and high-performing team of Research Governance Facilitators, Research Governance Coordinators and R&D administrators. They will be responsible for developing department policies and guidance and managing a portfolio of complex trials/studies that are under sponsor / co-sponsor review by Guy's and St Thomas (GSTT) and King's College London (KCL). As a governance specialist in the R&D department, the post-holder will be the key point of contact for the set-up of complex / high risk of our studies and to ensuring that GST R&D always has up to date process in the ever-changing regulatory landscape. The post-holder will also oversee the sponsorship and confirmation of capacity (C&C) of those they line-manage.This will include sponsor risk-assessments, ensuring the trust's compliance with national regulations in our local policies and standard operational procedures (SOPs).
Main duties of the job
Studies will include but are not limited to: clinical trials of medicinal products, device trials, and multi-centre Trials including international collaboration, along with student projects, qualitative and interventional studies.
You will be an experienced line-manager with excellent communication skills who is able to support world-class researchers, and influence those that you work with and line-manage. You will be highly organised and methodical approach to your work, be able to project manage service improvements and be able to support and develop junior members of the team. You will have pragmatic and solution-focused approach to set-up of research studies. You will have attention to detail and the writing skills to convey complex regulations in simple guidance researchers and training materials for R&D staff.
About us
Candidates should be aware that the R&D department staff are required to work in the R&D office, based at Guy's hospital a minimum of 3-days per week and travel between hospitals as required. Other flexible working will be considered as per Trust policies.
In line with our Trust Values the postholder will be:
Caring - we put patients firstWe provide patient and person-centred care. We care about others' needs and wellbeing. We listen. We are compassionate to ourselves and others. We reflect on our actions. We are respectful and welcoming.
Ambitious - we innovate and strive for excellenceWe innovate and strive for excellence. We act with integrity. We act on staff and patient feedback. We seek ways to improve the care and experience of others. We are efficient. We are committed to growth. We find new ways to deliver excellence.
Inclusive - we respect each other and work collaborativelyWe respect each other and work collaboratively. We act on diverse views. We put ourselves in 'others' shoes'. We are building an anti-racism organisation. We seek opportunities to collaborate. We show sensitivity towards diversity of culture.
Job description
Job responsibilities
You will be an experienced line-manager with excellent communication skills who is able to support world-class researchers, and influence those that you work with and line-manage. You will be highly organised and methodical approach to your work, be able to project manage service improvements and be able to support and develop junior members of the team. You will have pragmatic and solution-focused approach to set-up of research studies. You will have attention to detail and the writing skills to convey complex regulations in simple guidance researchers and training materials for R&D staff.
The successful candidate will have significant experience of working in an R&D department in an NHS or university and have in-depth knowledge of the HRA and NIHRs latest strategic developments as well as the approval processes for clinical research in the UK.
Interviews will be held in person at Guys Hospital.
Job description
Job responsibilities
You will be an experienced line-manager with excellent communication skills who is able to support world-class researchers, and influence those that you work with and line-manage. You will be highly organised and methodical approach to your work, be able to project manage service improvements and be able to support and develop junior members of the team. You will have pragmatic and solution-focused approach to set-up of research studies. You will have attention to detail and the writing skills to convey complex regulations in simple guidance researchers and training materials for R&D staff.
The successful candidate will have significant experience of working in an R&D department in an NHS or university and have in-depth knowledge of the HRA and NIHRs latest strategic developments as well as the approval processes for clinical research in the UK.
Interviews will be held in person at Guys Hospital.
Person Specification
Knowledge/Qualifications
Essential
- Relevant degree or professional qualification or equivalent experience
Desirable
- Postgraduate qualification
Experience
Essential
- Significant post-qualification work experience (5 years +) in medical/clinical research/R&D department.
- Specialist / in depth knowledge relating to HRA, MHRA NHS Ethics processes.
- Knowledge of HR / line-management, including relating to Research.
- Knowledge of the UK Policy Framework for Health and Social Care Research and other regulatory issues relating to medical/clinical research, including GDPR, data protection act, and clinical trials regulations (drug and medical devices).
- Excellent verbal and written
- Experience of managing administrative projects/project management.
- Competent to develop R&D guidelines/SOPs/policies.
Skills
Essential
- Ability to use own initiative when working independently and also to be able to work effectively as a member of a team and influence others
Person Specification
Knowledge/Qualifications
Essential
- Relevant degree or professional qualification or equivalent experience
Desirable
- Postgraduate qualification
Experience
Essential
- Significant post-qualification work experience (5 years +) in medical/clinical research/R&D department.
- Specialist / in depth knowledge relating to HRA, MHRA NHS Ethics processes.
- Knowledge of HR / line-management, including relating to Research.
- Knowledge of the UK Policy Framework for Health and Social Care Research and other regulatory issues relating to medical/clinical research, including GDPR, data protection act, and clinical trials regulations (drug and medical devices).
- Excellent verbal and written
- Experience of managing administrative projects/project management.
- Competent to develop R&D guidelines/SOPs/policies.
Skills
Essential
- Ability to use own initiative when working independently and also to be able to work effectively as a member of a team and influence others
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).
