Job summary
An exciting opportunity has arisen for an exceptional individual to be appointed as the Research Governance Manager within thegrowing R&D Office at the Royal Free Hospital.
The successful applicant will have excellent interpersonal and written communication skills, be practical, methodical and organised
Main duties of the job
The post-holder will be responsible for the provision of a comprehensive, high quality research management and governance (RM&G) service at the Royal Free London NHS Foundation Trust (RFL). Acting as an expert on research governance and research compliance matters, they will lead on the effective implementation of research regulatory standards at the trust and ensure MHRA inspection readiness at all times.
They will manage the implementation and maintenance of proportionate systems to ensure the highest standards of health research are met and ensure delivery of a high standard of RM&G service support to the trust.
They will play a leading role in the set-up, monitoring and reporting of RM&G Key Performance Indicator's (KPI's) and the performance management of these KPI's.
The post holder will manage and lead the trust R&D Office Research Governance team and ensure that the team is supported in meeting good research governance and ethical standards and is maintained as an effective, motivated and responsive team.
About us
The Trust is within the top 10 nationally for recruitment into NIHR adopted studies (2022_23). The R&D Office operates agile working for staff members and places the Trust's values at the heart of how we conduct our relationships with our staff, patients and stakeholders.
Job description
Job responsibilities
The post-holder will be responsible for the provision of a comprehensive, high quality research management and governance (RM&G) service at the Royal Free London NHS Foundation Trust (RFL). Overseeing the Research Governance section of the R&D Office, the successful candidate will act as an expert on research governance and research compliance matters and will lead on the effective implementation of research regulatory standards at the trust and ensure MHRA inspection readiness at all times.
For the full job description and responsibilities please refer to the PS and JD.
Job description
Job responsibilities
The post-holder will be responsible for the provision of a comprehensive, high quality research management and governance (RM&G) service at the Royal Free London NHS Foundation Trust (RFL). Overseeing the Research Governance section of the R&D Office, the successful candidate will act as an expert on research governance and research compliance matters and will lead on the effective implementation of research regulatory standards at the trust and ensure MHRA inspection readiness at all times.
For the full job description and responsibilities please refer to the PS and JD.
Person Specification
Operational
Essential
- Team player
- Performance management of others including objective setting
- Line management experience
- Evidence of teaching or training others
- NHS experience
Desirable
- Evidence of writing own training material or presenting to external parties
QMS Experience
Essential
- Expert knowledge of UK research regulations inclucding Medicines for Human Use (Clinical Trials) Regulations, Mental Capacity Act, HTA, GCP, the UK policy framework for health and social care research , GDPR and DPA
- Auditing or monitoring experience
- SOP writing and implementation experience
Desirable
- MHRA or FDA inspection experience
- Evidence of understanding of risk based approach to research
- Experience of SOP life cycle, writing, releasing, teaching, withdrawal
Communication
Essential
- Stakeholder engagement experience
- Ability to simplify complex information
- Knowledge of NIHR
Desirable
- Evidence of communication skills eg report writing or newsletter production
Information Management
Essential
- Management of data eg EDGE, EDC
Desirable
- Implementation of innovative electronic systems to streamline service
Person Specification
Operational
Essential
- Team player
- Performance management of others including objective setting
- Line management experience
- Evidence of teaching or training others
- NHS experience
Desirable
- Evidence of writing own training material or presenting to external parties
QMS Experience
Essential
- Expert knowledge of UK research regulations inclucding Medicines for Human Use (Clinical Trials) Regulations, Mental Capacity Act, HTA, GCP, the UK policy framework for health and social care research , GDPR and DPA
- Auditing or monitoring experience
- SOP writing and implementation experience
Desirable
- MHRA or FDA inspection experience
- Evidence of understanding of risk based approach to research
- Experience of SOP life cycle, writing, releasing, teaching, withdrawal
Communication
Essential
- Stakeholder engagement experience
- Ability to simplify complex information
- Knowledge of NIHR
Desirable
- Evidence of communication skills eg report writing or newsletter production
Information Management
Essential
- Management of data eg EDGE, EDC
Desirable
- Implementation of innovative electronic systems to streamline service
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).
