Job summary
An exciting opportunity has arisen for an exceptional individual to be appointed as the Quality Assurance Manager for the NIHR Royal Free Clinical Research Facility.
The Quality Assurance Manager is responsible for the development, implementation and maintenance of systems to assure the quality of clinical research undertaken within the Royal Free Hospital Clinical Research Facility.
The successful applicant will have in depth knowledge of clinical trial regulations and possess excellent interpersonal and written communication skills as well as being practical, methodical and organised.
Main duties of the job
Under the guidance of the CRF General Manager, the post holder will be responsible for the development, implementation and maintenance of systems to assure the quality of clinical research undertaken within the Royal Free Hospital Clinical Research Facility, in accordance with the International Conference on Harmonisation Good Clinical Practice Guidelines (ICH-GCP), Good Laboratory Practice (GLP) principles, the UK policy framework for health and social care research (2017) and the Medicines for Human Use (Clinical Trials) Regulations 2004, Medical Devices Regulations 2002 and subsequent amendments. The post holder will have a key role in co-ordinating working practices and policy implementation, ensuring the CRF is compliant with internal Standard Operating Procedures (SOPs), polices and external regulatory frameworks at all times.
The post holder will coordinate all necessary preparation for external audit and regulatory inspection by the Medicines and Healthcare Products Regulatory Agency (MHRA).
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
Develop and maintain systems to ensure that clinical trials carried out within the CRF are conducted in accordance with the new UK policy framework for health and social care research (2017), ICH GCP guidelines, GCLP principles and the Medicines for Human Use (Clinical Trials) Regulations 2004 and subsequent amendments.
Implement and monitor systems to ensure regulatory compliance throughout the lifecycle of all clinical studies, developing Quality Assurance (QA) procedures to support study initiation, study implementation, study close down and study archiving.
Interpret complex legislation relating to clinical research, identify implications for CRF operation and act to initiate necessary changes to practice in order to ensure that the CRF remains compliant with statutory regulations at all times.
See full JD/PS for comprehensive list of responsibilities
This vacancy has been advertised in accordance with the new NHS pay rate which will take effect from autumn 2024. Please note if your employment starts before the 24/25 pay scales are implemented you will be paid under the 23/24 pay scales and any backpay will be adjusted accordingly. Further information can be found athttps://www.nhsemployers.org/articles/pay-scales-202425.
Job description
Job responsibilities
Develop and maintain systems to ensure that clinical trials carried out within the CRF are conducted in accordance with the new UK policy framework for health and social care research (2017), ICH GCP guidelines, GCLP principles and the Medicines for Human Use (Clinical Trials) Regulations 2004 and subsequent amendments.
Implement and monitor systems to ensure regulatory compliance throughout the lifecycle of all clinical studies, developing Quality Assurance (QA) procedures to support study initiation, study implementation, study close down and study archiving.
Interpret complex legislation relating to clinical research, identify implications for CRF operation and act to initiate necessary changes to practice in order to ensure that the CRF remains compliant with statutory regulations at all times.
See full JD/PS for comprehensive list of responsibilities
This vacancy has been advertised in accordance with the new NHS pay rate which will take effect from autumn 2024. Please note if your employment starts before the 24/25 pay scales are implemented you will be paid under the 23/24 pay scales and any backpay will be adjusted accordingly. Further information can be found athttps://www.nhsemployers.org/articles/pay-scales-202425.
Person Specification
Knowledge and Qualifications
Essential
- First degree or equivalent in clinical or life sciences
- Evidence of further education / CPD
- Good knowledge of Research Governance
Desirable
- Formal Training / Certification in Quality Management
Experience
Essential
- Significant experience of undertaking, co-ordinating or managing clinical research
- Experience of developing and implementing QA procedures in clinical research
- Experience of undergoing an inspection and audit by an external authority
Desirable
- Experience of managing QA systems for early phase trials
- Experience of providing training in GCP
Skills & Abilities
Essential
- Excellent written and verbal communication skills
- Ability to interpret complex information in order to facilitate change
- Good negotiating skills and ability to influence others
- Confident in making autonomous decision relating to QA
Person Specification
Knowledge and Qualifications
Essential
- First degree or equivalent in clinical or life sciences
- Evidence of further education / CPD
- Good knowledge of Research Governance
Desirable
- Formal Training / Certification in Quality Management
Experience
Essential
- Significant experience of undertaking, co-ordinating or managing clinical research
- Experience of developing and implementing QA procedures in clinical research
- Experience of undergoing an inspection and audit by an external authority
Desirable
- Experience of managing QA systems for early phase trials
- Experience of providing training in GCP
Skills & Abilities
Essential
- Excellent written and verbal communication skills
- Ability to interpret complex information in order to facilitate change
- Good negotiating skills and ability to influence others
- Confident in making autonomous decision relating to QA
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).
