Approvals Specialist Development role
NHS AfC: Band 5
- NHS AfC: Band 5
- 6 months (Internal secondment - 6 x 0.5 FTE)
- Part time - 18.75 hours per week
- Redman Place
- £25,655 - £31,534 pro-rata
- 05/12/2021 23:59
The HRA is a Non Departmental Public Body with the remit to protect and promote the interests of patients and the public in health and social care research. We do this by supporting and promoting a robust and efficient regulatory and governance framework in the UK. We provide the Research Ethics Service (RES), Confidentiality Advice function, assessments and assurances on behalf of the NHS, and learning, guidance and advice for the research community. Our ambition is to make the UK a great place to do research, where more money invested in research goes into carrying out relevant, good quality research.
Our purpose is to ensure that research involving NHS patients and members of the public is approved through a proportionate and robust system, that they are provided with the information they need to help them decide whether they wish to take part, and that their opportunity to do so is maximised by simplifying the processes by which high quality research is assessed. We have already delivered significant improvements by centralising and simplifying the approval of research in the NHS in England, and are undertaking a range of significant programmes to deliver further improvements.
This is a developmental post to provide a development framework/pathway for the Approvals Specialist role. The post-holder will undertake training to establish a foundation in terms of the considerations involved in conducting HRA/HCRW assessments as per HRA Standards, legislation and legal governance framework. They will enhance awareness of centralised and local governance structures and the wider research environment as well as an understanding of governance and ethics surrounding the Approvals Service.
The expectation is that by the end of the part-time secondment, the post holder will have followed an established training plan and completed appropriate assessments of modules to establish learning progress as well as have a thorough understanding of what the Approvals Specialist role entails to support the post-holder personal progression and development.
The post-holder will have responsibility for the management of applications through the HRA Approval process. The post-holder will conduct HRA assessments as a key part of HRA Approval for research in the NHS to ensure that the study as proposed meets the HRA Standards. This will include the support of Research Ethics Committees and working with Approvals Officers/Administrators to ensure each study receives an appropriate review and is correctly documented.
Main duties of the job
The post holder will:
- Process research applications, undertaking elements of the review and ensuring coordinated communication with the applicant
- Conduct study assessments to HRA standards, recording review data in line with agreed processes
- Attend REC meetings
- Advise RECs on matters of procedure and standards in review of applications
- Advise Approvals Officers/Administrators on finalising information to be requested from applicants after review
- Advise on and appropriately triage/manage applications between those requiring Full REC review, Proportional review REC review, No REC review required, and those requiring HRA/HCRW Approval
- Advise on applicant queries
- Assess amendments requiring expert input
- Contribute to collection of accurate metrics and data to evaluate progress against Key Performance Indicators and compliance with procedures.
- Provide feedback and contribute to implementation of action plans for process modifications, and engage positively with such discussions and implementation of change
Working for our organisation
Working at the HRA, we are reminded daily of how important life is. As a flexible
working friendly organisation, we want to be sure that you can work in a way that is
best for you, not just us and the work we do.
We are committed to creating an inclusive workplace that promotes and values
diversity. We know from experience that different ideas, perspectives and
backgrounds create a stronger, more creative workplace that helps us to deliver the
best services. We welcome applications which represent the rich diversity of our
community: age, disability, gender identity and expression, ethnicity, religion or
belief, sex, sexual orientation and other diverse characteristics, and we have policies
in place to ensure that all applicants are treated fairly and consistently at every stage
of the recruitment process.
When applying to work here, speak to us about how we might be able to
accommodate a flexible working arrangement – if it works for us, we will do our best
to make it work for you.
Detailed job description and main responsibilities
This role sits within the HRA Approvals Service directorate which consists of various
teams that all work together to provide the appropriate approval for health research
in England and, for some applications, across the UK.
This directorate is responsible for:
- Delivering HRA Approval
- Supporting the Confidentiality Advisory Group and advising on the use of
confidential patient information without consent
- Working to refine the systems and processes researchers need to follow to
ensure a swift, robust and simple experience
- Providing guidance to applicants
- Providing training
- Working collaboratively with external partners to improve the research
To find out more and to understand the full duties of the role, please refer to the job
In submitting your application with us, please note the following:
We currently do not accept applications via recruitment agencies.
We do not hold a sponsorship licence and are unable to offer employment under any
Where applicants fail to demonstrate how they meet any one of the essential criteria
of the person specification, the application will not be shortlisted. You will be
considered based only on the information in your application form. CVs will not be
The HRA reserves the right to close this vacancy early should it receive a sufficient
number of applications.
- Degree-level qualification or evidenced ability to work at a similar intellectual level
Knowledge, Skills and Expertise
- Thorough understanding of the HRA role and remit
- Knowledge of principles and processes for approving and conducting health research in England, including legal and ethical requirements relating to research, and the ability to apply this knowledge practically
- Broad understanding of research methodologies and appropriate legislative and research management arrangements for different research types
- Excellent organisational skills with the ability to prioritise against a background of change and uncertainty
- Problem solving and analytical skills, including ability to interpret and prepare reports
- Computer literate, competent in the use of Microsoft programs
- Ability to work to frequent deadlines and to manage multiple processes and cases simultaneously
- Ability to work in a dynamic, rapidly evolving environment
- Knowledge of relevant legislation and national policy including Human Tissue Act, Mental Capacity Act, Data Protection Act, General Data Protection Regulation, Clinical Trials Regulations, which impacts on conduct of research
- Some understanding of NHS research funding and contracting arrangements
- Awareness of NIHR clinical research network structures in England
- Data analytical skills (both quantitative and qualitative) including the analysis of multiple sources of information to ensure compliance with targets and performance indicators
- Experience of working with people at all levels in an organisation
- Experience of working to tight deadlines
- Practical experience in research approvals systems (HRA, regulatory body, NHS R&D, Clinical Research Network, or university), or as a coordinator or facilitator of health research studies in the UK
- Highly self-motivated, confident, pro-active, innovative, with ability to work independently and on own initiative
- Flexible working approach, with proactive approach to change
- Commitment to team working and respect and consideration for the skills of others
- Interpersonal skills to include: • diplomacy and sensitivity • negotiating and influencing including ability to be assertive whilst maintaining a positive approach to managing workload • ability to work well with others, at all levels in an organisation including senior staff
- Ability to develop good communications with REC Chairs and Members and the extended research community
Applications from job seekers who require sponsorship to work in the United Kingdom (UK) are welcome and will be considered alongside all other applications. Please note that from January 2021, to work in the UK all candidates who are not UK or Republic of Ireland (RoI) nationals require sponsorship unless you have permission to work via another route. Non UK / RoI candidates wishing to apply can self-assess the likelihood of obtaining a Certificate of Sponsorship here. It is vital that you provide full and accurate details of your current immigration status on the application form. Overseas applicants applying for entry clearance into the UK must present a criminal record certificate from each country they have resided in continuously or cumulatively for 12 months or more in the past 10 years. Guidance can be found here. Not everyone needs a ‘Skilled Worker’ visa. If you are applying for a vacancy in health or adult social care, check if you’re eligible to apply for the Health and Care Worker visa instead. It’s cheaper to apply for and you do not need to pay the annual immigration health surcharge
Documents to download
Further details / informal visits contact
- Agnieszka Ziolek
- Job title
- Appovals Operations Manager
- Email address
- Telephone number