Job summary
Applications are invited from individuals with experience of working in research governance and a sound knowledge of clinical research. The CRDC Research Governance Officer sits within the Research Governance & Performance team in the Barts Health-Queen Mary University of London (QMUL) Joint Research Management Office (JRMO), which provides comprehensive support for study setup, research governance, finance, contracts, and other core functions. All trials will be reviewed by the CRDC Research Governance Officer to ensure compliance with the UK Policy Framework for Health & Social Care Research and current clinical trial and/or device regulations. The officer will ensure that trial conduct adheres to Good Clinical Practice (GCP), local Clinical Research Facility (CRF) policies, and standard operating procedures.
Main duties of the job
The Commercial Research Delivery Centre (CRDC) Research Governance Officer will support the setup and performance management of commercial studies taking place at Barts Health NHS Trust (Barts Health), Barking, Havering & Redbridge University Hospitals NHS Trust (BHRUT) and Homerton Healthcare NHS Foundation Trust (Homerton). This role is part of the North East London Commercial Research Delivery Centre (NEL CRDC), which operates collaboratively from Barts Health in partnership with BHRUT and Homerton. The NEL CRDC follows a unified approach to trial setup, industry engagement, governance, and monitoring procedures.
About us
Barts Health is one of the largest NHS trusts in the country, and one of Britain's leading healthcare providers.
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.
Job description
Job responsibilities
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 interestThe 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.ed in flexible working, please speak to the recruiting manager.
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
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 interestThe 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.ed in flexible working, please speak to the recruiting manager.
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
Experience
Essential
- Experience of clinical and/or NHS research management.
- Experience of managing multiple projects within a team
Desirable
- Clinical research experience in commercial life sciences industry
- Experience of working across multiple health care organistions
- Experience in providing training and guidance to researchers
- Experience in drafting R&D guidance documents
Skills
Essential
- Proven interpersonal skills
- Excellent ability to analyse and interpret research management information.
- Excellent IT skills, particularly in the use of Web applications and MS Office applications.
- Attention to detail.
Desirable
- Knowledge of systems and structures for the management of clinical research in the NHS
- Ability to design, map out, and implement effective governance approval pathways and processes.
Knowledge & Qualifications
Essential
- Educated to Degree level or equivalent experience in research governance and/or the conduct of research.
- Knowledge of governance and legislative framework for conducting clinical research studies
- Knowledge of the regulatory approvals process within the UK.
Desirable
- Specialist knowledge of ICH GCP and EU Clinical Trials Directive, Medicines for Human Use Regulations, UK Policy Framework for Health and Social Care Research.
- Understanding of commercial contract research feasibility processes.
Communication
Essential
- Ability to communicate complex information simply both orally and in writing
- Experience providing support and training to junior staff to develop their knowledge & skill
- Ability to negotiate in a tactful and confident manner to achieve the desired results
Desirable
- Prepare and deliver reports to a high standard
Specific Requirements
Essential
- Ability to prioritise & organise own workload
- Ability to work independently efficiently & as a member of a multi-professional team
- Sufficient to perform the duties of the post with any aids and adaptations
- Willingness to work flexibly
- Willingness to work across sites and research facilities within Barts Health NHS Trust and partner organisations as per service needs.
Person Specification
Experience
Essential
- Experience of clinical and/or NHS research management.
- Experience of managing multiple projects within a team
Desirable
- Clinical research experience in commercial life sciences industry
- Experience of working across multiple health care organistions
- Experience in providing training and guidance to researchers
- Experience in drafting R&D guidance documents
Skills
Essential
- Proven interpersonal skills
- Excellent ability to analyse and interpret research management information.
- Excellent IT skills, particularly in the use of Web applications and MS Office applications.
- Attention to detail.
Desirable
- Knowledge of systems and structures for the management of clinical research in the NHS
- Ability to design, map out, and implement effective governance approval pathways and processes.
Knowledge & Qualifications
Essential
- Educated to Degree level or equivalent experience in research governance and/or the conduct of research.
- Knowledge of governance and legislative framework for conducting clinical research studies
- Knowledge of the regulatory approvals process within the UK.
Desirable
- Specialist knowledge of ICH GCP and EU Clinical Trials Directive, Medicines for Human Use Regulations, UK Policy Framework for Health and Social Care Research.
- Understanding of commercial contract research feasibility processes.
Communication
Essential
- Ability to communicate complex information simply both orally and in writing
- Experience providing support and training to junior staff to develop their knowledge & skill
- Ability to negotiate in a tactful and confident manner to achieve the desired results
Desirable
- Prepare and deliver reports to a high standard
Specific Requirements
Essential
- Ability to prioritise & organise own workload
- Ability to work independently efficiently & as a member of a multi-professional team
- Sufficient to perform the duties of the post with any aids and adaptations
- Willingness to work flexibly
- Willingness to work across sites and research facilities within Barts Health NHS Trust and partner organisations as per service needs.
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).
