Job description & person
specification
Last updated:
04 September 2015
JOB DESCRIPTION
Post title:
Research Integrity and Governance Manager
Academic Unit/Service:
Research and Innovation Services
Faculty:
-
Career pathway:
MSA
Level:
5
*ERE category:
Posts responsible to:
Head: IP, Contracts and Policy (L6)
Posts responsible for:
Research Integrity Officers x 2 (L4)
Research Governance Officer (L3)
Post base:
Office-based
Job purpose
To lead the Research Integrity & Governance team (RIG Team) which provides specialist advice, guidance and
training to University staff to on all matters relating to research integrity and regulatory compliance.
Coordinate and manage the development, implementation and awareness raising of policies and procedures
to ensure the University’s compliance with the Research Integrity Concordat (Concordat), Department of
Health Research Governance Framework (RGF), Clinical Trials legislation, and other regulations applicable to
research.
Act as the University Representative for Sponsor obligations (in accordance with RGF and Health Regulatory
Authority) and key point of contact for Research Integrity (in accordance with the Concordat)
Key accountabilities/primary responsibilities
% Time
1. Foster and promote a culture of research integrity across the University.
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
Increase understanding amongst researchers of the need for compliance of
sometime complex legal requirements.

Raise the visibility and understanding of the ethical issues across the full breadth of
research undertaken including cultural, social sensitivity and environmental, security
sensitive, defence as well as human participant and animal research.

Develop comprehensive information resources and training programmes

Design an effective communications campaign and marketing materials to increase
awareness across the University.
Key accountabilities/primary responsibilities
% Time
2. Provide, and ensure the RIG Team provides, comprehensive support and guidance for all
staff and students on matters relating to research integrity, ethics and research governance,
using expert knowledge to resolve queries in a timely and professional manner.
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3. Lead on the development of all policies, processes and guidance to ensure best practice, to
foster a culture and understanding of research integrity and compliance with the Research
Integrity Concordat, wider policy and legal requirements.
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
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Providing advice and expertise to key committees including Research Integrity &
Governance Committee and the University Ethics Committee.
Ensuring coordination across relevant professional services and Faculties to policy
development and implementation.
Input to development of policies and implementation programmes to policies
relating to research lead by a different professional service department.
Ensure currency of policies by providing regular review and updating where
necessary to meet best practice and regulatory changes.
4. Act as the University Sponsor Representative for all research when required under the RGF,
or by the Medicines Health Regulatory Authority and/or Health Regulatory Authority.

Ensure standards and procedures are in place to meet the regulatory requirements
for ethical approval (including through NHS Research Ethics Committees (NRES)) and
for compliance with regulatory obligations including ongoing monitoring of studies.

Provide expert advice and guidance to staff on applying and amending applications
for NRES approval as well as for obtaining NHS R&D approvals.
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5. Maintain a close relationship with key NHS partners including UHS R&D, Solent NHS R&D,
Primary Care and Wessex AHSN. Maximising cooperation to ensure a streamlined approach
to supporting researchers including through joint office operations where appropriate.
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6. Responsibility for reporting and provision of advice on investigations of allegations of
research misconduct and academic integrity
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
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
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Work with Deans and Faculty HR Managers to formalise the annual research
misconduct reporting process.
Develop a standardised approach to support transparency and compliance with the
Concordat
Provide advice to investigations of allegations of misconduct.
Provide advice to Academic Integrity Officers in respect of research misconduct and
ethics investigating breaches of Academic Integrity by students.
7. Management of the RIG Team

Provide support, mentorship and guidance to the Research Integrity Officers and
Research Governance Officer.

Identifying areas for staff development and conduct PPDRs.
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8. Oversee the development, implementation and operation of University ethics and governance 5
systems including ERGO (www.ergo.soton.ac.uk). Ensure RIG Team provides expertise and
advice to researchers working with online systems used by NHS Trusts for clinical trial
management, or NRES for ethical approval and other regulatory approval systems.
9. Any other duties as allocated by the line manager following consultation with the post
holder.
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Special Requirements
Travel to attend meetings (primarily UK occasionally EU)
Willingness to work non-standard hours as reasonably required to fulfil the role
Internal and external relationships
Research Integrity & Governance Committee, University Ethics Committee ad Faculty Ethics Committee
Associate Deans Research, Academic Integrity Officers
Southampton Clinical Trials Unit and Human Tissue Act named licence holders and persons designate
Home Office Licence holder and Animal Welfare and Ethical Review Board
Professional Services - Legal Services, Library & colleagues in RIS
Academic, Researchers and students
Regulatory authorities – MHRA, HRA, NRES and the Export Control Office
Funders – especially NIHR and US Public Health Funders
NHS and Academic Collaborators in particular R&D personnel
Other external: ARMA, UKRIO, AFRE, Russell Group Research Integrity Forum
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PERSON SPECIFICATION
Criteria
Essential
Desirable
Qualifications,
knowledge &
experience
Skill level equivalent to
achievement of a professional
qualification or postgraduate
degree.
Understanding and awareness
of the wider regulatory
environment including: export
controls, anti-corruption and
bribery.
Proven experience of managing a
research integrity and/or
compliance function.
Detailed knowledge of the
Research Integrity Concordat and
of ethics and governance
standards.
Expert knowledge of Research
Governance Framework, Clinical
Trials legislation, Human Tissue
Act and Data Protection Act.
Thorough understanding and
experience working in an
academic environment or with
Universities.
Planning &
organising
Able to plan and manage major
new projects or significant new
activities, ensuring plans
complement broader
organisational strategy.
Problem
solving &
initiative
Able to identify broad trends to
assess deep-rooted and complex
issues.
How to be assessed
Application/Interview
Experience of the development
of guidance and procedures in
response to compliance with
new regulations or funder
requirements.
Understanding of policies
applicable to Research and
Funder requirements including:
Research Data Management,
conflicts of interest, security
and defence
Able to apply originality in
modifying existing approaches to
solve problems.
Experience of analysing complex
regulatory policy information
quickly and accurately, and
providing robust yet pragmatic
solutions
Management &
teamwork
Proven people management skills.
Able to manage team dynamics,
ensuring any potential for conflict
is managed effectively.
Able to formulate development
plans for own staff to meet
current and future skill needs.
Able to provide expert guidance
and advice to colleagues to
resolve complex problems.
Communicating Able to persuade and influence in
& influencing
order to foster and maintain
relationships.
Able to resolve tensions and
difficulties as they arise.
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Able to explain complex
regulatory and policy information
and presenting in an appropriate
format for target audience
Other skills &
behaviours
Special
requirements
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JOB HAZARD ANALYSIS
Is this an office-based post?
☒ Yes
If this post is an office-based job with routine office hazards (eg: use of VDU), no further
information needs to be supplied. Do not complete the section below.
☐ No
If this post is not office-based or has some hazards other than routine office (eg: more than use
of VDU) please complete the analysis below.
Hiring managers are asked to complete this section as accurately as possible to ensure the safety
of the post-holder.
## - HR will send a full PEHQ to all applicants for this position. Please note, if full health clearance is required
for a role, this will apply to all individuals, including existing members of staff.
ENVIRONMENTAL EXPOSURES
Occasionally
Frequently
Constantly
(<30% of time)
(30-60% of time)
(> 60% of time)
Outside work
Extremes of temperature (eg: fridge/ furnace)
## Potential for exposure to body fluids
## Noise (greater than 80 dba - 8 hrs twa)
## Exposure to hazardous substances (eg: solvents, liquids, dust, fumes,
biohazards). Specify below:

Frequent hand washing
Ionising radiation
EQUIPMENT/TOOLS/MACHINES USED
## Food handling
## Driving university vehicles(eg: car/van/LGV/PCV)
## Use of latex gloves (prohibited unless specific clinical necessity)
## Vibrating tools (eg: strimmers, hammer drill, lawnmowers)
PHYSICAL ABILITIES
Load manual handling
Repetitive crouching/kneeling/stooping
Repetitive pulling/pushing
Repetitive lifting
Standing for prolonged periods
Repetitive climbing (ie: steps, stools, ladders, stairs)
Fine motor grips (eg: pipetting)
Gross motor grips
Repetitive reaching below shoulder height
Repetitive reaching at shoulder height
Repetitive reaching above shoulder height
PSYCHOSOCIAL ISSUES
Face to face contact with public
Lone working
## Shift work/night work/on call duties
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