Job Description and Person Specification

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Job description & person
specification
Last updated:
04 September 2015
JOB DESCRIPTION
Post title:
Research Integrity Officer (Policy and Ethics)
Academic Unit/Service:
Research and Innovation Services
Faculty:
-
Career pathway:
MSA
Level:
4
*ERE category:
Posts responsible to:
Research Integrity & Governance Manager
Posts responsible for:
Post base:
Office-based
Job purpose
To provide specialist advice and guidance on all matters relating to achieving and maintaining compliance
with the Research Integrity Concordat and the sometimes complex legal requirements applicable to
research. Support to furthering the University’s commitment to meeting the highest ethical and integrity
standards.
Take a leading role in the implementation of relevant University Policies and development of information
resources to ensure best practice and understanding amongst staff of the ethical requirements (beyond
human participation and animal research).
To provide expert guidance and support to internal and external stakeholders throughout the compliance
reporting process and for obtaining necessary approvals, licences, registrations and certifications.
Key accountabilities/primary responsibilities
1.
% Time
Responsible for providing advice and guidance on a breadth of ethics issues in relation to 20
cultural and social sensitive, environmental, security and defence research, including:
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Using expert knowledge to resolve queries in a timely and professional manner.
Provide robust yet proportionate guidance in relation to category of risk
applicable to the research.
Support and advice to Faculties and Faculty Ethics Committee members to further
consistent and harmonised approach across the University
Support to researchers on applications for ethics review using the University’s
ethics and governance systems including ERGO (www.ergo.soton.ac.uk).
Contribute to the development and maintenance of all policies, processes, and
systems (including ERGO).
Design and undertaken a compliance assessment plan to check compliance with
University Ethics Policy, and current ethical approvals
Key accountabilities/primary responsibilities

2.
% Time
Design a review programme for quality of ethical reviews and approvals given
providing recommendations and guidance to achieve improvement
Provide advice and guidance to staff in relation to a range of policies & codes applicable
to research and enterprise including
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Code of Conduct for researchers
Conflicts of Interests,
Research Integrity,
Procedures for investigation or research misconduct,
Export controls and Dual Use

Support on applications and amendments for licences, permissions and other
registrations

Apply specialist knowledge of the online approval systems used (e.g. Spire for
ECO)
20
3.
Coordinate and contribute to the development, maintenance and implementation of
policies and codes described in section 2 above. Provide expert input and advice to the
development of research and enterprise policies lead outside of the RIG Team to ensure
consistency and harmonised approach across the University.
10
4.
Take a leading role in relation to management and reporting of complaints and
allegations of research misconduct
15
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Develop and implement a system to track and manage complaints and allegations
of misconduct
Work closely with HR and Faculties to ensure status and outcomes of any
investigations are recorded
Report on a project/incident basis as necessary to Funders and external bodies
Report in accordance with Research Integrity Concordat
Communicate with complainants
Provide input to institutional and project audits
5.
Develop and deliver a training programme and awareness raising campaign promoting
understanding of the University research and enterprise policies, regulatory compliance
and ethical review process to all staff and students including to FEC members, and
Supervisors.
15
6.
Maintaining an up-to date intranet resource of information for all staff on all aspects of
Research Integrity, the research and enterprise policies and relevant regulatory
requirements. Develop and maintain publically facing web pages to promote the
University’s record and progress towards compliance with the Research Integrity
Concordat and the quality of University research.
10
7.
Maintain a strong awareness of regularly changing policy and wider governance
environment by working with a range of external stakeholders. Alert senior management
to changes which may impact upon University guidance or procedures.
5
8.
Work cooperatively and effectively in the RIG Team and more widely in RIS
5
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9.
Deputising where necessary for RIG Manager on matters within expertise
Providing continuity and advice where possible in absence of RIG colleagues
Mentoring and support to Research Governance Officer
Advice and support to Faculty based RIS staff especially Research Support Officers
supporting ethics reviews
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)
Internal and external relationships
RIG Team and wider RIS team
Academics, researchers and students
Faculty Ethics Committee members and Academic Integrity Officers
Legal Services – especially Data Protection Officer
Communication & Marketing
Regulatory Authorities – Export Control Office
NHS and Academic Collaborators in particular R&D personnel
Funders – RCUK
UKRIO, AFRE & ARMA
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PERSON SPECIFICATION
Criteria
Essential
Desirable
How to be assessed
Qualifications,
knowledge &
experience
Skill level equivalent to
achievement of HND, Degree,
NVQ4 or basic professional
qualification.
Understanding of the ethical
and regulatory approvals
applicable to clinical research.
Application/Interview
Regulatory compliance, legal
qualification or equivalent
experience.
Experience in applying for or
supporting applications for
NRES, MHRA and other
approvals applicable to clinical
trials regulation and
governance requirements.
In depth appreciation of how to
identify actual or potential
conflicts of interest and strategies Knowledge and understanding
to assist with managing the same. of relevant legislation including
Human Tissue Act, Data
Detailed knowledge and
Protection Act, EU Clinical Trials
understanding of Research
Directive, Good Clinical Practice
Integrity Concordat
(GCP) and any other legislation
Understanding of export controls,
which could influence and
dual use and security sensitive
affect the conduct of research
research issues.
Demonstrable understanding and
experience of best practice in
relation to the development of an
ethical review process which is
proportionate to different types
and risk categories of research.
Experience working in a research
intensive University and/or an NHS
research support role.
Planning &
organising
Able to seek opportunities to
progress a broad range of
activities within professional
guidelines and in support of
University policy.
Experience in coordinating and
undertaking a programme of
monitoring and compliance
checking activity
Experience of successful project
management.
Problem
solving &
initiative
Experience of analysing complex
regulatory policy information
quickly and accurately, and
providing robust yet pragmatic
solutions.
Management &
teamwork
Able to proactively work with
colleagues in other work areas to
achieve outcomes.
Able to provide expert guidance
and advice to colleagues to
resolve complex problems.
Able to delegate effectively in a
matrix working environment,
understanding the strengths and
weaknesses of team members to
build effective teamwork.
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Communicating Able to persuade and influence in
& influencing
order to foster and maintain
relationships.
Able to resolve tensions and
difficulties as they arise.
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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