Job responsibilities
KNOWLEDGE,
SKILLS AND EXPERIENCE REQUIRED
Qualifications
Literate and numerate
Good standard of education to a minimum of GCSE level
Experience
Previous administrative experience
IT skills
Familiar with the process of clinical trials
Training
Willing to undergo training as required
Specialist
Knowledge
Insight into role and responsibilities of post
Disposition/Attitude
Able to work as part of a multidisciplinary team
Committed to working with people
Practical
Skills
Good interpersonal skills
Effectively communicate with multidisciplinary team members
CORE
BEHAVIOURS AND SKILLS
Motivated
Professional
attitude and behaviour
Able
to adapt to service led changes
Flexible
approach to working practices and duties
Able
to work on own or as part of a team
Attention
to detail
Good
time keeping
Time
management skills
Organisation
skills
Able
to use own initiative
Good
written and oral communication skills with the ability to communicate with
staff
at all levels
Reliable,
trustworthy and honest approach to work and colleagues
Fair
approach when dealing with colleagues and team
CORE
KNOWLEDGE AND UNDERSTANDING
The
post holder will ideally have an understanding of the principals of clinical
research
and be expected to develop a working knowledge of clinical research.
The
post holder will have the ability to comply with ICH GCP guidelines for
clinical
research as well as the LTH Trust guidelines and policies.
The
post holder will ideally be familiar with the process of clinical trials and
be
willing
to undergo further training as required to gain the knowledge shortly after
entering
the post.
PRINCIPAL
DUTIES & AREAS OF RESPONSIBILITY
Patient
support;
To assist in the evaluation of patient eligibility, in liaison with other
appropriate
health
care professionals for clinical trial entry, involving the co-ordination of
tests,
obtaining results and arranging transport and documentation of specific
specimens
as per clinical trial protocols
To assist the co-ordination of the patients journey through the clinical
trial
protocol
e.g. requisition and organisation of any necessary investigations,
procurement
of patient notes.
Team
Working;
To ensure that all members of the multidisciplinary team are aware of the
current
trials
portfolio; status of studies, and any trial amendments.
To provide feedback to MDT members on issues relating to recruitment,
protocol
amendments
and trial results.
To disseminate information from Senior Research Nurse/Midwife to the MDT.
The post holder will demonstrate the ability to manage their own
administrative
case-load,
working as part of the multidisciplinary team.
In conjunction with all members of the research team and appropriate
healthcare
professionals,
develop a cohesive and flexible team working environment across
the
service.
Arrange departmental meetings, including booking venues, sending out papers
and
taking minutes
Administration;
To coordinate the maintenance of all documentation required in site files,
including
archiving arrangements. .
To assist with the collection and collation of trial data and completion of
trial
documentation
in accordance with trial protocols.
To ensure that all data entry is compliant with protocol requirements.
To ensure that all trial data is submitted to the study sponsor within the
specified
time
constraints.
To manage and respond to any data queries received.
To ensure timely entry of recruitment figures to all relevant data bases.
To
report monthly to the Senior Research Nurse accrual data on all patients
recruited
into the study portfolio highlighting local activities that might impact on
achievement
of the departments aims.
Maintain an agreed level of supplies required across the clinical trials team
and
complete
orders in line with departmental requirements
General;
To contribute to the development of the portfolio of trials.
To help implement local and national and international quality standards,
professional
standards, recommendations and guidelines from national reports.
The post holder will adhere to the Data Protection Act and maintain patient
confidentiality
at all times.
The post holder will act in a professional manner at all times when dealing
with
patients,
their relatives and representatives from both external and internal
sources.
The post holder will deal with telephone enquiries from staff, patients and
carers
ensuring
that appropriate personnel are informed in order for actions to be taken.
The post holder will be expected to represent the research team in a
professional
manner
at meetings and events.
The post holder will be expected to work to ICH GCP guidelines at all times.
As a new post holder, an induction and training programme will be provided
for
key
aspects of this role, however the post holder will be expected to take
advantage
of opportunities to attend meetings and workshops to enhance their
knowledge
of Clinical Research and clinical care.
The staff member will ensure that (s)he follows the Trusts hospital
infection
prevention
and control policies and procedures to protect patients, staff and
visitors
from healthcare-associated infections. He or she will ensure that(s)he
performs
the correct hand hygiene procedures, when entering clinical areas.
To undertake any other duties deemed appropriate to the role, including
interaction
with patients and families when this is deemed appropriate.
Health
and Safety/Risk Management
All
staff are responsible for working with their colleagues to maintain and
improve
the
quality of services provided to our patients and other service users. This
includes
complying at all times with the Leeds Teaching Hospitals NHS Trust
Policies,
including Health and Safety policies, in particular by following agreed
safe
working procedures, and reporting incidents using the Trust Incident
Reporting
system.
Infection
Control
The
jobholder must comply at all times with the Leeds Teaching Hospitals NHS
Trust
Infection Control policies, in particular by practising Universal Infection
Control
Precautions. Hand hygiene must be performed before and after contact
with
patients and their environment.
Equality
and Diversity
The
jobholder must comply with all policies and procedures designed to ensure
equality
of employment and that services are delivered in ways that meet the
individual
needs of patients and their families. No person whether they are staff,
patient or visitor should receive less favourable treatment because of their
gender,
ethnic origin, age, disability, sexual orientation, religion etc.
Patient
and Public Involvement
The
Trust has a statutory duty to involve patients and public in evaluating and
planning
services. All staff have a responsibility to listen to the views of patients
and
to contribute to service improvements based on patient feedback.
Training
and Personal Development Continuous Professional
Development
The
jobholder must take responsibility in agreement with his/her line manager for
his/her
own personal development by ensuring that Continuous Professional
Development
remains a priority. The jobholder will undertake all mandatory
training
required for the role.
Respect
for Patient Confidentiality
The
jobholder should respect patient confidentiality at all times and not divulge
patient
information unless sanctioned by the requirements of the role.
COMMUNICATION
& WORKING RELATIONSHIPS
Internal:
Consultants,
All
members of the clinical multidisciplinary team
Lab
Staff,
Regulatory
Committees,
R
& I,
Research
Nurses/Midwives,
Management,
Other
Trust departments
External:
Pharmaceutical/Device Companies
Clinical
Trials Units e.g. MRC
NIHR
Clinical Research Network
Other
Trials Networks
HRA
Other
Hospitals
Universities
