Job Description and Person Specification (HR5)
Job Description
School/Department:
Post Title:
Please enter Level under
appropriate Career
Pathway
ERE Category
School of Medicine Cancer Sciences Division Clinical Trials
Unit
Clinical Trial Coordinator
ERE
TAE
MSA
CAO
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Academic Posts
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(mixed)
Research
only
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Clinical
Non-Academic Posts
Teaching
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Education
Development
Posts Responsible to (and Level):
Clinical Trials Manager
Posts Responsible for (and Level):
Where appropriate and as required:
Data officer, Level 2b
Clinical Trials Assistant, Level 2a
Job Purpose:
The University of Southampton Clinical Trial Unit (CTU) designs, initiates, conducts and
analyses high quality national and international clinical trials of treatments to directly
influence routine clinical practice.
The appointed person will take responsibility for the development and operational
management of one or more clinical trials within the CTU.
Key Accountabilities/Primary Responsibilities:
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Assisting with trial development in collaboration with Chief
Investigators, the Trials Manager and other relevant personnel.
Identifying when protocol amendments become necessary and taking
appropriate action.
Ensuring regulatory requirements are fulfilled and that all approvals
and authorisations are secured. Taking responsibility for applications
as appropriate and assisting/advising participating investigators with
local requirements.
Ensuring the appropriate randomisation service is available and
assisting with this service as necessary
Taking responsibility for trial set up and activation; identifying
appropriate centres and a clinical lead in each, establishing links with
key members of staff and ensuring essential documentation is in
place.
Visiting clinical centres and monitoring trial conduct as appropriate to
ensure protocol compliance and good patient management
Acting as the main point of contact for the relevant trial/s.
Explaining and promoting the trial (including newsletter production,
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website updates) to ensure wide participation and good accrual of
patients.
Ensuring the trial recruits at an acceptable rate at each centre.
Suggesting and implementing strategies for improving recruitment.
Responsibility for monitoring drug accountability at trial clinical sites
and ensuring Good Clinical Practice guidelines are adhered to.
Visiting laboratories to ensure that specimens are being received,
processed, and stored efficiently and in accordance with the protocol
and Good Clinical Practice guidelines.
Organising and participating in relevant trial specific and CTU
meetings, including Investigator meetings
Writing and submitting trial progress reports as and when required
As appropriate assist with the development and maintenance of SOPs
Establishing good working relationships with the Research Networks
across the UK; providing regular updates and trial information as
appropriate. Ensuring network managers are familiar with the trial.
Supporting research nurses provided from the networks.
Providing support to the Clinical Trial Manager/s for the management
of other research trials
Participation in the development and maintenance of quality systems
and clinical audit of research activity.
Ensuring practice adheres to all relevant University policies and
procedures
Any other duties appropriate to the band assigned by the Clinical Trial
Manager
Internal & External Relationships: (nature & purpose of relationships)
Other staff within Southampton CTU to ensure good working relationships
Trial Chief Investigator and other members of Trial Management Group
Trial investigators
Research nurses
Pharmacists
Other staff at participating centres
Trial funders
Trial oversight committees (DMEC, TSC)
Special Requirements: The Clinical Trial Coordinator will be based at Southampton
General Hospital within the CTU. There will however be a requirement to travel to
participating centres and Investigators across the UK and possibly internationally.
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Person Specification
How to be
assessed
Criteria
Essential
Desirable
Qualifications,
Knowledge and
Experience:
Degree (or equivalent)
in relevant subject
Postgraduate
qualification in
relevant area.
Application
Health care
background / Nursing
qualification
Application
Knowledge and
experience of medical
research methodology
and statutory clinical
trial regulations, GCP
and research
governance
requirements.
Evidence of continuing
professional
development
Application /
Interview
GCP training within
last 2 years.
Application /
Interview
Planning and
Organising:
A high degree of
organisation
Good attention to
detail
Problem Solving and
Initiative:
Ability to prioritise
tasks
Management and
Teamwork:
Project management
experience
Communicating and
Influencing:
Good interpersonal
skills
Ability to liaise with
individuals at all levels
at different
establishments
Communicates
effectively in both
spoken and written
English
Other Skills and
Behaviours:
Personal drive and
initiative
Special Requirements:
Flexible working
arrangements
Ability to travel
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Job Hazard Analysis Form - Appendix to Job and Person Specification
Please tick one of the following statements:
This post is an office-based job with routine office hazards e.g. use of VDU (if ticked, no
further information needs to be supplied)

This post has some hazards other than routine office e.g. more than use of VDU
Please tick all those that apply, and put N/A if not applicable
Environmental Exposures
O*
Outside work
N/A
Extremes of temperature (eg fridge/ furnace)
N/A
Potential for exposure to body fluids
##
N/A
Noise (greater than 80 dba - 8 hrs twa)
##
N/A
Exposure to hazardous substances (eg solvents, liquids, dust, fumes,
biohazards). Specify ………………………………………………………….
##
F
C
N/A
Frequent hand washing
N/A
Ionising radiation.
N/A
Equipment/Tools/Machines used
Food Handling
##
N/A
Driving university vehicles(e.g. car/van/LGV/PCV)
##
N/A
Use of latex gloves (note: prohibited unless specific clinical necessity)
##
N/A
Vibrating tools ( e.g. strimmers, hammer drill, lawnmowers)
##
N/A
Physical Abilities
Load manual handling.
N/A
Repetitive Crouching/Kneeling/Stooping
N/A
Repetitive Pulling/Pushing
N/A
Repetitive Lifting
N/A
Standing for prolonged periods
N/A
Repetitive Climbing i.e. steps, stools, ladders
N/A
Fine motor grips (e.g. pipetting)
N/A
Gross motor grips
N/A
Repetitive reaching below shoulder height
N/A
Repetitive reaching at shoulder height
N/A
Repetitive reaching above shoulder height
N/A
Psychosocial Issues
Face to face contact with public
N/A
Lone working
N/A
Shift work/night work/on call duties
##
N/A
O – Occasionally (up to 1/3 of time); F – Frequently (up to 2/3 of time); C – Constantly (more than 2/3 of
time) ## denotes to HR the need for a full PEHQ to be sent to all applicants for this position.
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