Job Description and Person
Specification
Last updated:
02/11/2015
JOB DESCRIPTION
Post title:
Clinical Trials Laboratory Technician
Academic Unit/Service:
WISH Laboratory, Cancer Sciences Unit
Faculty:
Faculty of Medicine
Career Pathway:
Technical and Experimental (TAE)
*ERE category:
n/a
Posts responsible to:
Research Fellow in WISH laboratory, Cancer Sciences Unit
Posts responsible for:
None
Post base:
Office-based/Non Office-based (see job hazard analysis)
Level:
3
Job purpose
To co-ordinate (under the direction of the line manager/s) the collection, logging, processing, and storage of
patient samples for clinical trials and other research projects within the WISH laboratory, complying with all
legal requirements within an ICH-GCP compliant regulated area. To carry out clinical trial associated endpoint
and research assays. To contribute to clinical trial reports and sponsor update meetings. To be responsible
for clinical trial equipment maintenance (in liaison with the Divisional Laboratory Manager) and clinical trial
laboratory stocks and consumables.
Key accountabilities/primary responsibilities
% Time
1.
To liaise with UHS research nurses to be responsible for the collection of human
samples when required from the Southampton General Hospital site, and with CRUK
clinical trial administrators, to coordinate the collection and processing/storage of
samples from external centres.
2.
To process and store samples using standard operating procedures within an ICH-CGP 20 %
compliant sample management system, requiring meticulous record keeping and
database management for all processes undertaken. Techniques to include peripheral
blood mononuclear cell (PBMC) isolation and cryopreservation, and storage of serum as
well as tumour disaggregation and sorting by flow cytometry.
3.
To carry out a range of tests using well defined protocols, analysing and evaluating the 30 %
results, and contributing to the interpretation of results and the development of
techniques, specifically enzyme linked immunosorbant assay (ELISA) for anti-vaccine
antibodies ELISPOT for anti-vaccine T cells, and flow cytometric analysis of PBMC
populations and phosphorylation of signalling proteins.
5%
Key accountabilities/primary responsibilities
% Time
4.
High degree of meticulous record keeping of sample processing and analysis.
Contribution to clinical trial report writing and sponsor update teleconferences.
Administrative tasks associated with specified research funding, for example risk
assessment of research activities, organisation of project meetings and
documentation. .
15 %
5.
To take a proactive role in the day-to-day organisation of the clinical trial laboratory,
specifically clinical trial equipment maintenance and logs, and writing and updating
Standard Operating Procedures associated with all work, processes and procedures
relating to clinical trial activities.
5%
6.
To advise on the pricing and purchasing of consumables and ensure adequate stocks
of supplies.
5%
7.
To ensure accurate completion of all documentation, reports and records according to
GCP for laboratories.
5%
8.
To ensure compliance with health and safety processes within work environment,
including equipment maintenance in accordance with technical and health and safety
procedures.
5%
9.
To train students or new staff members in techniques, procedures, and safe and
effective use of equipment.
5%
10.
Any other duties as allocated by the line manager following consultation with the post
holder.
5%
Internal and external relationships



ECMC Director and Research Fellow within WISH facility as Line Managers
Principal Investigator for trial and external trial administrators/managers for contributions to
reporting on trial progress
Collaborative/administrative working with other WISH staff, UHS research nurses, and QA
management
Special Requirements
Able to work outside of core hours
Willing to undergo vaccination against Hep B for occupational health
PERSON SPECIFICATION
How to be
assessed
Criteria
Essential
Desirable
Qualifications:
Skill level equivalent to HNC, A
Level, NVQ3
BSc Degree
Evidence /
certificate
Knowledge:
Relevant laboratory experience in a
responsible role.
Knowledge of and training in GLP /
GCP or similar.
CV
Application
Interview
Working to SOPs under/ within a
regulated laboratory environment.
Experience:
Knowledge of Clinical Trial
Directive.
CV
Application
Interview
Experience of working within a
quality management system.
CV
Application
Interview
Relevant research experience to
include flow cytometry, ELISA and
PBMC extraction from blood
Planning and
Organising:
CV
Application
Interview
Experience of co-ordinating the
Influencing the organisation of a
organisation and implementation of project on multiple sites.
new process and procedures.
CV
Application
Interview
Able to organise own research
activities to deadlines and quality
standards
Problem Solving
and Initiative:
Able to offer or accept appropriate
level of assistance, to allow for
effective progress.
Willing to express constructive
ideas.
Management and
Teamwork:
Propose initiatives and ideas with
the ability to positively accept /
acknowledge or implement new
proposals.
Interview &
probation
Ability to accurately analyse and
interpret specialist data, presenting
summary information in a clear and
concise format
Able to work alone or within a small Experience of providing training to
team complying within regulatory
colleagues and students in relation
frameworks.
to technical tasks.
Interview &
Probation
Understand the strengths and
weaknesses of others to help
teamwork development.
Communicating
and Influencing:
Effective communication across
participating sites including ability
to liaise with senior staff, including
managers, nurses.
Positive motivational influence on
all parties concerned with this role,
internal and external.
Interview &
Probation
Able to present research results at
group meetings, and to trial
management/
principal investigators
Other Skills and
Behaviours:
Meticulous attention to detail for
sample tracking via paperwork and
databases.
Positive attitude to work, and
colleagues
Interview &
Probation
Computer skills including data
input / information retrieval via
databases.
Special
Requirements:
(Training given for
all processes
undertaken)
Willing and able to work with
biological human materials to
include blood/blood products and
tissue.
Ability to undertake out of hours
working
Willing and able to work with liquid
nitrogen for purposes of sample
processing and storage.
Willingness to attend any necessary
training, courses or seminars
related to the post.
Interview &
Probation
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
N/A
Extremes of temperature (eg: fridge/ furnace)


## Potential for exposure to body fluids
## Noise (greater than 80 dba - 8 hrs twa)
N/A
## Exposure to hazardous substances (eg: solvents, liquids, dust, fumes,
biohazards). Specify below:


Frequent hand washing
Ionising radiation
N/A
EQUIPMENT/TOOLS/MACHINES USED
## Food handling
N/A
## Driving university vehicles(eg: car/van/LGV/PCV)
N/A
## Use of latex gloves (prohibited unless specific clinical necessity)
N/A
## Vibrating tools (eg: strimmers, hammer drill, lawnmowers)
N/A
PHYSICAL ABILITIES
Load manual handling

Repetitive crouching/kneeling/stooping
N/A
Repetitive pulling/pushing
N/A
Repetitive lifting
N/A

Standing for prolonged periods
Repetitive climbing (ie: steps, stools, ladders, stairs)
N/A

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
N/A