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Research Regulation Specialist

NHS AfC: Band 7

Main area
Admin
Grade
NHS AfC: Band 7
Contract
Fixed term: 24 months
Hours
Full time - 37.5 hours per week
Job ref
980-HRA514-C
Site
3rd Floor – Barlow House,
Town
Manchester
Salary
£40,057 - £45,839 per annum
Salary period
Yearly
Closing
Today at 23:59
Interview date
27/09/2021

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.

Job overview

An internal vacancy has arisen in the Coordination and Standardisation team for a full-time Band 7 Research Regulation Specialists on a fixed term basis of two years.  Applications are invited from staff with significant experience in the research regulation and management environment. The successful applicant will take responsibility for a number of projects designed to streamline the application, approval and set-up of research across the UK, interacting at senior levels within and outside the HRA. If you are interested in learning more about the post please contact alastair.nicholson@hra.nhs.uk for an informal discussion.

Main duties of the job

The Research Regulation Specialist is a varied and complex role that will require an in depth knowledge of NHS research regulatory and governance systems and experience of managing the review of research through at least one part of current UK systems.

Your expertise will be needed to help the HRA in developing content for policy documents, guidance and training materials.

Collaborative working with stakeholders across the UK and with those engaged on related HRA projects will be key.

Working for our organisation

The Coordination and Standardisation Team works with internal and external stakeholders on projects and process development to standardise facilitative research management and regulation across the UK, in line with HRA responsibilities under the Care Act (2014).

Detailed job description and main responsibilities

KEY RESPONSIBILITIES

Communication

·       Develop and maintain good relationships with the HRA’s external stakeholders

·       Engage with stakeholders on specific pieces of work in line with agreed engagement approach/plan

·       Create and maintain professional relationships with HRA staff, and volunteer members of Research Ethics Committees and the Confidentiality Advisory Group, including writing reports or preparing responses for consideration by staff or members.

·       Adapt existing knowledge and experience to work within the unique context of the HRA.

·       Develop written content for the HRA website, operational policies, guidance and other written communications to address gaps, revisions, or clarifications of policy or good practice nationally

·       Take and transcribe formal minutes of complex and contentious meetings

 Planning and Organisational Skills / Analytical Skills

·       Plan and organise own work in line with agreed activities, interdependencies and deadlines

·       Respond to highly complex queries and ensure the responses are in line with existing policy and guidelines

·       Analyse complex applications or queries where there is no existing policy or guidance and advise on development of new national policy or guidance

·       Advise independently on the interpretation and compliance with statutory or regulatory matters and the interpretation of HRA policies and procedures to members of HRA staff and to researchers.

·       Actively keep up to date with all changes to relevant research guidance and legislation and pro-actively provide updates and training on the statutory and regulatory framework to researchers and HRA staff.

·       Develop training materials for delivery in online or face to face formats on statutory, regulatory or good practice aspects of health research.

 Responsibility for Patient / Client Care

·       Incidental, if any

Responsibility for Policy and Service

·       Identify the need for guidance, policies or other written information relating to statutory, regulatory or good practice requirements nationally to address areas where there may be differing interpretations, lack of clarity or novel issues.

·       Map and analyse process and synthesise recommendations and road map or action plan

·       Evaluate evidence and the legal basis for operational policy and guidance and draft for discussion

Responsibility for Finance

·       No budgetary responsibility

 Responsibility for Staff HR Leadership / Training

·       Required to demonstrate own work to others on routine basis for others’ development, or on occasion to support with temporary staff.

·       Devise and provide training to groups of staff on implementation of agreed process

Information Resources

·       Responsible for business input to systems development to support HRA and UK-wide working

·       Create work instructions on processes or policy implementation ensuring interoperability with other stakeholders, including Devolved Administrations

·       Use of HARP and IRAS to generate, or inform reports on work in progress, or proposals.

Research and Development

·       Undertake gap analysis or audits on new processes as part of testing and implementation

·       Plan and execute desktop research to synthesise evidence for projects, process and policy

 Freedom to Act

·       Acts with minimal supervision, but in line with agreed plan

·       Decision to act within agreed parameters of a project or specifically delegated decision-making

 Physical Effort / Physical Skills / Working Conditions

·       Job will require post holder to sit at a desk and use a VDU for most of their day.

Mental Effort / Emotional Effort

·       The post holder will be required to communicate difficult decisions to the research community which can cause distress. The post holder will need to communicate information both tactfully and tenaciously

Other

·       Work collaboratively as part of a team and be sensitive to the characteristics of working in an open plan office environment

·       Undertake other duties commensurate with the responsibilities of the position in discussion with line manager

·       Fulfil mandatory requirements for continuous professional development ensuring that a high level of current professional knowledge and expertise is maintained.

SPECIAL CONDITIONS:

Equal Opportunities

The post holder must comply with and promote equal opportunities and accordingly must avoid any behaviour which discriminates either directly or indirectly against colleagues, potential employees, patients or clients on the grounds of age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion and belief, sex and sexual orientation, trade union membership, offending background or any other personal characteristic. 

The post holder must, at all times, carry out their responsibilities with due regard to the equal opportunities policies.

 

Health and Safety

Under the Health and Safety at Work Act (1974), it is the responsibility of individual employees at every level to take care of their own health and safety and that of others who may be affected by their acts at work.  This includes co-operating with the organisation and colleagues in complying with health and safety obligations to maintain a safe environment and particularly by reporting promptly any defects, risks or potential hazards.

 

All employees are required to act in accordance with their responsibilities under the Health and Safety at Work Act.

The post holder must be aware of the responsibilities placed upon them under the Health and Safety Act 1974 to ensure that agreed procedures are carried out and that a safe working environment is maintained for patients, visitors and employees.

 

Risk Management

Staff at all levels have a responsibility for ensuring that risks are managed at work group and local level.  This will include, but not be limited to, managing corporate, reputational, operational, financial, business continuity, health & safety and information governance risks. This process will include the assessment and effective control of all acceptable risk situations.

As an employee you will be expected to maintain a high level of awareness and assist in the process of reporting incidents, assessing risks and reporting unsafe occurrences and co-operate with any investigations undertaken.

Employees will be required to adhere to all HRA policies and procedures and to undertake statutory and mandatory training.

Smoke Free Policy   

The HRA has a smoke free policy and it is the responsibility of employees to co-operate fully with management in the implementation of this policy.  The purpose of the policy is to provide a healthy smoke-free environment for the benefit of patients, visitors and staff, and all employees are expected to comply; this includes all premises and grounds.

Person specification

Qualifications

Desirable criteria
  • Masters qualification in legal or ethical aspects of health or medicine

Experience

Essential criteria
  • At least three years’ experience of managing research applications through at least one part of the approvals process (eg REC review or R&D review)
  • Experience of development of quality assurance measures

Qualifications

Essential criteria
  • Degree level education or demonstrable equivalent profession experience

Knowledge, Skills and Exepertise

Essential criteria
  • Expert knowledge of current government policy and relevant legislation such as the Research Governance Framework, Clinical Trials Regulations, Data Protection Act, Mental Capacity Act and the Human Tissue Act
  • Ability to plan and prioritise own workload and manage time effectively
  • Work flexibly and creatively, and quickly and accurately when under pressure, working to tight deadlines

Experience

Desirable criteria
  • Experience of developing or delivering training for researchers

Experience

Essential criteria
  • Service development experience

Analytical and Judgemental Skills

Essential criteria
  • Well-developed analytical capabilities
  • Identifies and evaluates areas for potential service improvement and enables and encourages others to understand reason for change against competing interests and how they can contribute

Interpersonal Skills

Essential criteria
  • Outstanding written communication skills
  • Is able to recognise and reflect on barriers to effective communication, anticipating difficulties and modify communications appropriately
  • Communicates effectively in a wide variety of contexts about difficult matters/or in difficult situations
  • Listens to and respects the needs of stakeholders and/or colleagues
  • Presents a good image of themselves and where they work through their attitude, behaviour, competence and professional appearance e.g. presenting and discussing ideas, sharing views and exploring difficult issues
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Documents to download

Apply online now

Further details / informal visits contact

Name
Alastair Nicholson
Job title
Manager - Coordination and Standardisation
Email address
alastair.nicholson@hra.nhs.uk
Telephone number
Teams