Job summary
GCP and Research Governance Manager
Applications are invited from individuals with strong background and experience in Good Clinical Practice and MHRA regulated trials management to join the Joint Research Management Office (JRMO). The JRMO is a joint research and development office which manages clinical research on behalf of Barts Health NHS Trust and Queen Mary University London.
This is a very busy department and the GCP and Research Governance Manager is an integral role linking the teams in the JRMO with our researchers to ensure the Research Management and governance objectives of both organisations are met.
The post holder will provide expert advice and guidance to researchers in the set-up, oversight and management of MHRA regulated studies sponsored by the Trust and/or University from set up to close out. They will also have oversight of sponsors monitoring activities and line management responsibilities of the clinical trial monitors.
Main duties of the job
The successful applicant will have substantial experience of undertaking or managing health research, including managing MHRA regulated clinical trials with the NHS, academic institution, pharmaceutical company, or contract research organisation.
You must have expert knowledge of UK CTIMP, ATMP and Clinical investigation legislation and regulations and GCP requirements and research governance requirements. A working knowledge of research quality assurance systems and Sponsor oversight activities (including monitoring) are also essential.
The role includes a large amount of training delivery so the ability to prepare and deliver confidently and excellent communication skills are needed.
The post holder will support the Senior GCP and Compliance Manager within the GCP and Compliance team.
The post is full-time starting salary (NHS Band 7 subject to final AfC Job Matching outcome) will be in the range of £ (HR add in the range) per annum exclusive of London Allowance.
About us
The Barts Health group of NHS hospitals is entering an exciting new era on our improvement journey to becoming an outstanding organisation with a world-class clinical reputation. Having lifted ourselves out of special measures, we now have the impetus and breathing space to chart a fresh course in which we are continually striving to improve all our services for patients.
Our vision is to be a high-performing group of NHS hospitals, renowned for excellence and innovation, and providing safe and compassionate care to our patients in east London and beyond. That means being a provider of excellent patient safety, known for delivering consistently high standards of harm-free care and always caring for patients in the right place at the right time. It also means being an outstanding place to work, in which our WeCare values and behaviours are visible to all and guide us in how we work together.
We strive to live by our WeCare values and are committed to promoting inclusion, where every staff member has a sense of belonging. We value our differences and fully advocate, cultivate and support an inclusive working environment
We are dedicated to being an outstanding place to work and will work with you to get the best experience. We know flexible working is not a one size fits all and will mean something different to everyone. We are inclusive, so if you are interested in flexible working, please speak to the recruiting manager.
Job description
Job responsibilities
The post is based at the Joint Research Management Office, Barts Health, Whitechapel campus.
Candidates must be able to demonstrate their eligibility to work in the UK in accordance with the Immigration, Asylum and Nationality Act 2006. Where required this may include entry clearance or continued leave to remain under the Points Based Immigration Scheme
Informal enquiries about this post can be made to Dr Mays Jawad, Research Governance Operations Manager via m.jawad@qmul.ac.uk or 02078827279.
To apply please visit [BLT HR to add weblink to NHS Jobs]
The full job description provides an overview of the key tasks and responsibilities of the role, and the person specification outlines the qualifications, skills, experience, and knowledge required. For both documents, please view the attachment/s below.
Job description
Job responsibilities
The post is based at the Joint Research Management Office, Barts Health, Whitechapel campus.
Candidates must be able to demonstrate their eligibility to work in the UK in accordance with the Immigration, Asylum and Nationality Act 2006. Where required this may include entry clearance or continued leave to remain under the Points Based Immigration Scheme
Informal enquiries about this post can be made to Dr Mays Jawad, Research Governance Operations Manager via m.jawad@qmul.ac.uk or 02078827279.
To apply please visit [BLT HR to add weblink to NHS Jobs]
The full job description provides an overview of the key tasks and responsibilities of the role, and the person specification outlines the qualifications, skills, experience, and knowledge required. For both documents, please view the attachment/s below.
Person Specification
Qualifications
Essential
- Degree level qualification in a health related or scientific subject
- Recognised GCP course
Desirable
Experience
Essential
- Extensive experience in coordination or oversight of clinical health research, including clinical trials
- Experience of working on behalf of a sponsor on MHRA regulated Clinical trials
- Experience of working on behalf of a sponsor in the NHS, and academic institution, pharmaceutical company or contract research organization
- Experience of monitoring clinical trials (including site visits and report writing) and regulating research in the UK
- Experience of direct line management
Desirable
- Experience of working in NHS or Academic R&D
- Experience of undertaking or managing early phase trials
- Experience of undertaking or managing Clinical Investigations
Knowledge
Essential
- Robust and indepth knowledge of UK CTIMP, ATMP, Clinical investigation legislation and regulations and Research Governance and GCP requirements
- Good working knowledge of United Kingdom regulatory approval systems.
- Thorough working knowledge of processes for sponsors oversight of starting up clinical trials of medicinal products and clinical investigations through to completion.
Desirable
- Awareness of NHS and governmental research policy and strategy including (NIHR/HRA/MHRA/EMA)
Skills
Essential
- Attention to detail, including numerical and written word
- IT literate
- Problem solving skills
Desirable
- Evaluation or audit skills
Other
Essential
- Able to deal calmly and confidently with all professional groups
- Good organisational skills with the ability to manage and priorities own workload and meet deadlines
- Ability to work independently without direct supervision
- Decisive and assertive
- Flexible and proactive approach
- Self-Motivated
Person Specification
Qualifications
Essential
- Degree level qualification in a health related or scientific subject
- Recognised GCP course
Desirable
Experience
Essential
- Extensive experience in coordination or oversight of clinical health research, including clinical trials
- Experience of working on behalf of a sponsor on MHRA regulated Clinical trials
- Experience of working on behalf of a sponsor in the NHS, and academic institution, pharmaceutical company or contract research organization
- Experience of monitoring clinical trials (including site visits and report writing) and regulating research in the UK
- Experience of direct line management
Desirable
- Experience of working in NHS or Academic R&D
- Experience of undertaking or managing early phase trials
- Experience of undertaking or managing Clinical Investigations
Knowledge
Essential
- Robust and indepth knowledge of UK CTIMP, ATMP, Clinical investigation legislation and regulations and Research Governance and GCP requirements
- Good working knowledge of United Kingdom regulatory approval systems.
- Thorough working knowledge of processes for sponsors oversight of starting up clinical trials of medicinal products and clinical investigations through to completion.
Desirable
- Awareness of NHS and governmental research policy and strategy including (NIHR/HRA/MHRA/EMA)
Skills
Essential
- Attention to detail, including numerical and written word
- IT literate
- Problem solving skills
Desirable
- Evaluation or audit skills
Other
Essential
- Able to deal calmly and confidently with all professional groups
- Good organisational skills with the ability to manage and priorities own workload and meet deadlines
- Ability to work independently without direct supervision
- Decisive and assertive
- Flexible and proactive approach
- Self-Motivated
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).
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website (opens in a new window).
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).
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website (opens in a new window).
