R&I Quality Assurance Manager

Job summary

Are you an enthusiastic, dynamic and self-motivated clinical research professional looking for a new and exciting challenge? Why not considercontributing to research by joining the Research and Innovation department at London North West University Healthcare NHS Trust.


An exciting opportunity has arisen for a highly motivated Quality Assurance Manager with proven research experience who is capable of driving and maintaining the quality of clinical research across R&I within our Trust

Main duties of the job

The post holder will provide assurance that all research conducted in the Trust and across the wider R&I department is delivered to a consistentstandard of quality, through a programme of regular review and audit. They will develop and maintain a robust understanding of researchregulations and legislation.


The post holder will be based primarily within Northwick Park Hospital; however, they will be expected to engage with and maintain a visiblepresence across all LNWH sites and act as a primary point of contact for escalation of quality queries.

About us

London North West University Healthcare NHS Trust (LNWH) cares for the people of Brent, Ealing, Harrow and beyond.


Our team of more than 8,200 clinical and support staff serve a diverse population of almost one million people.


We run major acute services at:


o Northwick Park Hospital: home to one of the busiest emergency departments (A&E) in the country. The hospital provides a full range of services including the country's top-rated hyper-acute stroke unit and one of only three hyper-acute rehabilitation units in the UK


o St Mark's Hospital: an internationally renowned specialist centre for bowel disease


o Ealing Hospital: a busy district general hospital providing a range of clinical services, as well as 24/7 emergency department and urgent care centre, and specialist care at Meadow House Hospice


o Central Middlesex Hospital: our planned care site, hosting a range of surgical and outpatient services and collocated with an urgent care centre.


We are a university teaching NHS trust, in recognition of the important role we play in training clinicians of the future and bringing the benefits of research to the public.

Job description

Job responsibilities

To view the main responsibility, please see the attached the Job Description and Person Specification.

Job description

Job responsibilities

To view the main responsibility, please see the attached the Job Description and Person Specification.

Person Specification

Education/Qualifications

Essential

• Educated to Master's level or equivalent level of professional experience and knowledge
• Project Management qualification

Desirable

• Re

Knowledge Experience

Essential

• Extensive experience of auditing and/or monitoring
• Working to the UK Statutory Instruments for clinical trials and ICH Good Clinical Practice either a pharmaceutical company, contract research organisation, NHS or academic setting
• Experience of reviewing standard operating procedures
• Management of aspects of GCP operations including responsibility for one or more system, process or activity in a quality capacity e.g. SOP administration
• Project management experience including use of project management tools and presentation of project plans to senior colleagues
• Experience of all aspects of the research process
• Report writing skills using funding portals and national databases

Desirable

• Experience of writing and implementing standard operating procedures.
• Experience in project managing grants
• Line management experience
• know

Skills, Abilities and Attributes

Essential

• Excellent presentation / teaching skills
• To engage staff and work collaboratively
• Computer literate especially Microsoft Word, Excel and PowerPoint
• Demonstrates a high level of written and verbal communication conveying complex information, teaching, and presentation.
• Basic understanding of statistics
• Ability to work alone and as part of a team

Desirable

• Experience of training and mentoring staff

Person Specification

Education/Qualifications

Essential

• Educated to Master's level or equivalent level of professional experience and knowledge
• Project Management qualification

Desirable

• Re

Knowledge Experience

Essential

• Extensive experience of auditing and/or monitoring
• Working to the UK Statutory Instruments for clinical trials and ICH Good Clinical Practice either a pharmaceutical company, contract research organisation, NHS or academic setting
• Experience of reviewing standard operating procedures
• Management of aspects of GCP operations including responsibility for one or more system, process or activity in a quality capacity e.g. SOP administration
• Project management experience including use of project management tools and presentation of project plans to senior colleagues
• Experience of all aspects of the research process
• Report writing skills using funding portals and national databases

Desirable

• Experience of writing and implementing standard operating procedures.
• Experience in project managing grants
• Line management experience
• know

Skills, Abilities and Attributes

Essential

• Excellent presentation / teaching skills
• To engage staff and work collaboratively
• Computer literate especially Microsoft Word, Excel and PowerPoint
• Demonstrates a high level of written and verbal communication conveying complex information, teaching, and presentation.
• Basic understanding of statistics
• Ability to work alone and as part of a team

Desirable

• Experience of training and mentoring staff

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.

Certificate of Sponsorship

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 .


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. .


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.

Certificate of Sponsorship

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 .


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. .

Employer details

Employer name

London North West University Healthcare NHS Trust

Address

Northwick Park Hospital

Harrow

HA13UJ



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