NIHR Research Support Services framework - competencies for Research and Development staff
Research Support Services (RSS) framework
The NIHR Research Support Services framework helps to make the initiation and delivery of research studies faster and easier. The framework of
tools includes an operational capability statement, study planning and risk assessment, guidelines for effective local standard operating procedures
(SOPs) and a competency framework to help develop consistent, streamlined and risk-proportionate research management practice across the NHS in
England. (www.nihr.ac.uk/systems/Pages/Research_Support_Services.aspx)
Competencies
This set of practical competencies has been developed by a team of experienced NHS R&D managers who understand what an effective research
support team needs to know, understand and be able to do, in order to provide an effective service for health research in an organisation.
How to use the competencies
These competencies recognise the diversity of roles within organisations and can be used in a “pick and mix” style to suit individual requirements.
Each competency has five levels to reflect a range of abilities from a new or inexperienced team member to a proactive leader of activity.
The competencies are an aid to identifying and developing skills but it is for managers and team members to decide how they are used and to what
level. They are designed to be usable for:
 Developing job descriptions
 Assessing current skill levels
 Working towards new skills and objectives
 Staff appraisal, performance review and personal development
1
Competencies for R&D staff – November 2013
Level
E
D
C
B
A
A. Supporting (the growth and delivery of) NHS Research within own organisation
A1. Strategic context
A1.1 National
objectives and
priorities.
Is unaware of
national objectives
and priorities for
research.
Is aware of national
objectives and
priorities for research
but is not involved in
articulating them.
Is able to advise
researchers on national
objectives and priorities
for research.
Promotes national
objectives and priorities
for research.
Develops local strategy
for research in line with
national objectives and
priorities.
A1.2 Local strategic
direction.
Is unaware of the
local strategy for
research.
Is aware of the local
strategy for research
but is not involved in
developing or
articulating it.
Is able to advise
researchers on the local
strategy for research in
their organisation.
Promotes the local
strategy for research
through presentations
and training.
Sets the local strategy for
research in line with
national objectives and
priorities and ensures its
implementation.
A1.2 Promotion of
research.
Is unaware of the
need to promote
research.
Understands the
Actively promotes
importance of
research within own
promoting research
department.
but is not part of their
role.
Promotes the use of
research in evidence
based practice and the
importance of research
to patients and the
organisation at an
executive level.
Engages with external
bodies to promote the
conduct of research
within own and
partner organisations.
2
Competencies for R&D staff – November 2013
Level
A1.3 Chief
executive/Board
engagement to
support research
activity.
E
Is unaware of the
need and benefits of
chief
executive/Board
engagement in
research.
D
C
B
A
Understands the
need and benefits of
chief executive/Board
level engagement in
research but is not
part of their role.
Understands and is
proactive in
promoting/seeking chief
executive/Board
engagement to support
research in the
organisation.
Leads on the
organisation’s R&D
Operational Capability
Statement (OCS) for
Board consideration and
sign off and publication.
Understands the
importance of keeping
the Board aware of key
performance indicators
(KPIs) for research and
keeping the OCS up to
date.
Identifies and presents
opportunities and risks at
executive level for
consideration and takes
proactive action to
implement the decisions.
Is aware of the
organisation’s
stakeholders and
partnerships but
does not understand
their role
Is aware of the
organisation’s immediate
stakeholders and
partnerships and works
effectively with them at a
transactional level.
Understands how own
role and others fit
within and complement
the range of
stakeholders and
partnerships and the
wider health research
agenda (e.g. the NIHR
and Health Research
Authority).
Is able to work
strategically with the
range of stakeholders
and partnerships to
deliver the organisation’s
objectives.
A2. Working with external Partners
A2. Stakeholders &
Partnerships.
Is unaware of the
organisation’s
immediate
stakeholders and
partnerships.
3
Competencies for R&D staff – November 2013
Level
E
D
C
B
A
A2.2 Research
networks.
Is unaware of
research networks.
Is aware of research
networks but unclear
of their role.
Is aware of and
understands the role of
research networks and
works with them to
support researchers and to
share information.
Works collaboratively
with research networks
to implement new local
initiatives.
Takes an active
leadership role in driving
continuous improvement
across research networks
to which the organization
belongs.
A2.3 Industry.
Is unaware of the
difference between
commercial and
non-commercial
research studies.
Is aware of the
difference between
commercial and noncommercial research
studies but is not part
of their role.
Facilitates the opening of
commercial studies at
sites. Takes part in
feasibility and site
selection visits.
Facilitates the opening
of and extends the
oversight of commercial
studies to ensure
projects are recruiting
to time and target.
Applies proactive
commercial insight to the
delivery of R&D in the
organisation and takes a
strategic view on the
importance of working
with industry.
Understands the wider
role of individuals in the
team in working
effectively and takes care
to understand the roles
and workloads of others.
Actively manages team
working and delegates
responsibilities where
appropriate.
Ensures roles and
responsibilities for
research are clear within
the team working
environment and
facilitates wider
collaborative team
working between R&D
and other departments
within own organization
and bridging
A3. Working as a team to deliver successful research projects
A3.1 Team working.
Does not
understand the role
of team working.
Understands the role
of team working and
is supportive of the
team helping others
where necessary.
4
Competencies for R&D staff – November 2013
Level
E
D
C
B
A
organizational
boundaries.
A3.2 Good customer
Service.
Is unaware of the
need for good
customer service in
the department.
Understands the
need for good
customer service and
applies it within their
role.
Promotes and delivers a
culture of good customer
service across the team.
Promotes good
customer service and
takes action where
expectations fall.
Is able to create,
establish and monitor a
good customer service
culture in the
department and wider
stakeholder and
partnerships.
A3.3 Standard
Operating Procedures
(SOPs).
Is unaware of SOPs
in the office.
Is aware of the SOPs
that are relevant to
their role but does
not understand the
wider implications.
Uses SOPs that are
relevant to their post, can
train others in their use
and is proactive in
identifying any changes
required.
Has a full understanding
of all SOPs in the
department and any
updating required and
can train others in their
use.
Reviews and challenges
SOPs on local and
national merit.
A3.4 Role of service
support departments.
Is unaware of the
role of service
support
departments.
Is aware of the role of
service support
departments in the
delivery of research.
Is aware of and ensures
investigators and other
users are aware of the role
of service support
departments in their
research. Uses early
assessment tools (e.g. the
Research Support Service
Framework planning tool).
Works with investigators
and service support
departments from an
early point to ensure
research gets
undertaken and
delivered effectively.
Engages with support
departments to ensure
research is appropriately
supported and delivered
at a strategic level. Takes
remedial actions when
necessary.
5
Competencies for R&D staff – November 2013
Level
E
D
C
B
A
B. Supporting research projects throughout their lifecycle and managing research delivery
B1 Supporting development of new studies – early stages
B1.1 Protocol advice.
Is unaware of the
purpose of a
protocol.
Is aware of the
purpose of a protocol
but unable to advise
on content.
Understands the
importance of a robust
protocol. Can signpost
researchers to research
design and other support
services.
Liaises with the NIHR
Research Design Service
or other sources of
advice and researcher to
help ensure a robust
protocol is developed.
Provides advice to
researchers on research
methodology and
protocol design.
B1.2 Sponsorship
decisions.
Is unaware that
decisions are made
around sponsorship.
Is aware of the
information required
in deciding to sponsor
but is not part of their
role.
Is able to advise and
explain to researchers the
information required for
the decision to sponsor.
Is able to make the
sponsorship decision for
defined studies.
Undertakes the final
decision on whether to
sponsor a study and
ensures that a
mechanism for oversight
of project is in place.
B1.3 Intellectual
Property (IP).
Is unaware of the
meaning of IP.
Is aware of IP but
does not understand
its implications.
Has a good understanding
of IP.
Is able to advise
researchers on the
organisation’s IP policy.
Manages and negotiates
research IP on behalf of
the organisation.
B1.4 Scientific Peer
Review.
Is unaware of the
scientific
requirements of a
research project.
Is aware that
research needs to be
safe and scientifically
sound.
Understands the role of
peer review.
Able to advise others on
how to obtain peer
review.
Has a good working
relationship with
academic partners and
actively promotes
scientific review.
6
Competencies for R&D staff – November 2013
Level
E
D
C
B
A
B2 Supporting good financial and contractual management
B2.2 Funding for
research.
Is unaware of the
need for research to
be financed.
Is aware that
research needs to be
financially supported
but unsure of the
mechanisms for this.
Aware of the different
funding avenues for
commercial and noncommercial studies.
Understands the role of
funding bodies, their
requirements and the
importance of
appropriate research
funding being available.
Actively sources funding
solutions locally and
nationally for research.
B2.3 Funding for
research support.
Is unaware of the
various methods of
financially
supporting researchrelated services.
Is aware that
research-related
services can be
supported from
different sources but
unsure which is
appropriate.
Is able to signpost
researchers to relevant
information on financial
support for researchrelated services.
Is able to advise
researchers on local and
NIHR support funding
streams.
Is able to explain and
apply AcoRD and the
NIHR funding streams
including e.g. Research
Capability Funding (RCF).
B2.4 Costing a project.
Is unaware of the
importance of
costing a research
project.
Is aware of relevant
costing templates
(e.g. NIHR) but does
not use them every
time.
Has a good understanding
of research costs, NHS
support costs and
treatment costs. Can
signpost people to the
relevant member of
staff/source of
information.
Is able to advise
researchers and staff on
costing a project. Can
complete a simple
costing template and
negotiate realistic costs.
Has a relationship with
the service support
departments. Ensures
that there are agreed
processes in place for
calculating and accepting
project costs. Can
negotiate on realistic
costs with external
partners/ commissioners.
7
Competencies for R&D staff – November 2013
Level
E
D
C
B
A
B2.5 Contracts for
research.
Is unaware of the
need for contracts
for research
activities.
Is aware that
contracts can be
required but has
limited understanding
of how contracts
affect the study
management or the
process for creating
them.
Has a good understanding
of contracting with
commercial companies
and non-commercial
organisations. Aware how
contracts affect the
management of a study
and can signpost people to
the relevant member of
staff/source of
information.
Works with commercial
companies and noncommercial
organisations and is
aware of when a
contract is needed. Can
administer noncommercial agreements.
Forms a good working
relationship with the
company and can
negotiate a commercial
contract and advise
researchers on noncommercial contracts.
B2.6 Invoicing
requirements.
Is unaware of the
need to invoice for
services related to
research.
Is aware that
invoicing is important
but is not part of their
role.
Understands the
importance of appropriate
invoicing to the
organisation and their role
in the invoicing process.
Proactively manages the
invoicing process with
colleagues.
Oversees systems for
invoicing for
commercial/other
income generating
studies.
Applies the study
planning tools to
highlight potential
problems/risks.
Escalates issues and
delegates work to
others.
Promotes the use of the
study planning tools to
identify and mitigate
risks to research
initiation and delivery
and reports on their
impact. Deals with
escalated problems
B3. Supporting Feasibility and risk assessments of proposed research
B3.1 Research Support Is unaware of study
Services (RSS) (includes planning tools
other similar in-house
variations) planning
tools.
Is aware of study
planning tools but is
not part of their role.
Understands study
planning tools and takes
delegated actions from
others.
8
Competencies for R&D staff – November 2013
Level
E
D
C
B
A
B3.2 Feasibility
process.
Is unaware of the
need for project
feasibility.
Is aware that studies
should be delivered
well but not of the
process for deciding
the number of
participants or
resources.
Understands the
importance of feasibility
and is able to deliver a
robust method for
deciding appropriate
numbers of participants
and resources.
Is able to develop and
deliver a robust
feasibility review
system. Engages with
researchers on the
importance of
feasibility.
Manages the feasibility
process and ensures
researchers are fully
aware of their
responsibilities around
project delivery.
B3.3 Proportionate
Risk management.
Is unaware that
projects may have
risks and that they
need to be treated
differently
(proportionately).
Is aware that projects
may have risks that
need to be treated
differently
(proportionately) but
does not understand
why.
Understands what a
proportionate risk
management assessment
is and their own role in
making an assessment.
Is able to lead a risk
management
assessment taking
pragmatic actions and
escalating concerns
based upon the results.
Is able to advise on
legislation and risk and is
able to manage study
risks proportionately.
B3.4 Project
recruitment strategy.
Is unaware of the
need to develop
recruitment
strategies.
Is aware that there is
a different
recruitment strategy
and recruitment
process for every
study.
Understands what can
prevent or improve
recruitment and can
advise on avoiding pitfalls.
Is able to explore
options with research
team and collectively
decide on best
recruitment strategy.
Promotes the
development of
recruitment strategies.
9
Competencies for R&D staff – November 2013
Level
E
D
C
B
A
B4. Supporting Research Study Management and Delivery
B4.1. Research study
set-up.
Is unaware of what
needs to be in place
before a research
study can start
recruiting.
Is aware of what
needs to be in place
before recruitment
can start.
Is able to advise
researchers on what needs
to be in place before
recruitment can start.
Is able to work with
researchers to ensure
that set up processes
are completed in a
timely way and allow a
prompt start to
recruitment.
Establishes a system
which ensures prompt
study set up (post
approval) and research
team readiness to start
recruitment.
B4.2 First patient first
visit metric.
Is unaware of the
time within which
the first patient
should be recruited.
Is aware of the first
patient metric but is
not part of their role.
Is able to remind and
advise researchers on how
to ensure patients are
available to a study
through robust feasibility.
Is able to engage with
the research team to
ensure patients are
available and meet the
study criteria. Reports
on first patient metric
results.
Establishes a system for
recording and reporting
the first patient into a
study. Delegates the
delivery of the system.
B4.3 Meeting the NIHR
metrics and contract
benchmarks.
Is unaware of the
NIHR metrics and
contract
benchmarks.
Is aware of the NIHR
metrics and contract
benchmark
requirements at team
level but not of any
wider implications.
Is aware of the NIHR
metrics and contract
benchmark requirements
and their wider
importance and impact
and is able to advise
others.
Is able to implement
processes and solutions
that allow the
organisation and
investigators to meet
the NIHR metrics and
contract benchmark
requirements.
Works with senior staff
to develop the strategy
to meet the NIHR metrics
and contract benchmark
requirements and
communicates the
impact of metrics on the
organisation.
B4.4 Using internal key
performance
indicators (KPIs) to
Is unaware of the
purpose and usage
Is aware of KPIs but is
not involved in their
Is aware of KPIs and uses
them at team level to
Develops KPIs to report
to senior managers on
Develops and oversees
KPIs and local strategy to
ensure performance is
10
Competencies for R&D staff – November 2013
Level
E
D
C
B
A
monitor performance.
of KPIs.
usage.
monitor performance.
performance.
monitored and reported
to the chief
executive/Board.
B4.5 Supporting
research delivery.
Is unaware that
researchers need to
be supported in
order to deliver the
objectives of the
research.
Is aware of the need
to support
researchers to meet
the objectives and
metrics but not the
mechanism for doing
so.
Understands the
importance of supporting
research, study
recruitment and delivery.
Monitors recruitment and
escalates concerns.
Acts on escalated
concerns about delivery
and performance and is
able to support research
teams in developing
remedial action plans.
Takes an overview of
successful and
unsuccessful studies and
leads on determining the
future of those research
projects.
B4.6 Research
management advice
for all types of
research in which the
organisation[s]
participate.
Is unaware of the
requirements of a
researcher facing
role.
Is able to give
signposting advice to
senior R&D
colleagues or to
service departments
providing support.
Is able to provide advice to
research teams on good
research practice and
responsibilities, referring
to study protocols and
contractual agreements
when necessary.
Manages the overall
delivery of research
advice for the
organisation.
Promotes a holistic view
of research and ensures
the team has the skills
and abilities to support
research management.
B4.7 Internal and
external
auditing/monitoring
requirements.
Is unaware of the
need for and
learning from robust
auditing and
monitoring of work
undertaken by and
of the office.
Is aware that regular
auditing and
monitoring checks
need to be carried
out but does not
understand why.
Understands the reasons
and information required
for audit and monitoring
and their role.
Is able to implement
and advise others on
audit and monitoring
systems.
Establishes an auditing
and monitoring system
and report on the system
outputs to assure key
stakeholders of robust
governance.
11
Competencies for R&D staff – November 2013
Level
E
D
C
B
A
B4.8 Research
Misconduct.
Is unaware of the
concept of research
misconduct.
Is aware of the
concept of research
misconduct but not
of the policies and
guidance.
Is aware of and able to
follow policies and
guidance on research
misconduct and can seek
guidance on potential
research misconduct
issues.
Is able to advise staff on
the types of situation
which may lead to
research misconduct.
Instigates the
appropriate actions in
cases of research
misconduct.
B4.9 Research study
closure.
Is unaware of the
need to close a
research study
internally.
Is aware that
research studies need
to be closed on
internal systems but
does not understand
how.
Is able to monitor the
closure of research studies
on internal systems.
Ensures that
appropriate final
reporting and close out
measures are taken on a
study.
Ensures research studies
are closed and accurate
activity reports are made
available to the Trust
Board and NIHR
Networks (B4.3, B4.4).
B4.10 Publication and
communication of
research findings.
Is unaware that
research findings
should be published.
Is aware that
research findings
should be published
and can signpost staff
to relevant articles.
Is able to discuss and
advise researchers on the
publication of research
findings for the Trust and
lay audience.
Ensures that research
findings are published
and evidence is
acknowledged
throughout the life of
the project.
Through local and
national channels
actively supports the
publication and adoption
of research findings into
practice.
12
Competencies for R&D staff – November 2013
Level
E
D
C
B
A
C. Understanding Governance and Good Practice for NHS Research (national)
C1. Understanding and assessing the regulatory and legislative compliance of a study
C1.1 Complying with
the Research
Governance
Framework.
Is unaware of the
Research
Governance
Framework (RGF).
Is aware of the RGF
but cannot describe
its purpose.
Understands the sections
of the RGF that are
appropriate to their role.
Understands how the
framework applies to
what they do and can
relate it to the role of
others in the team.
Advises others on the
content and application
of the RGF.
C1.2 NHS local decision
process.
Is unaware of the
local decision
process required
before a research
project can proceed
in the organisation.
Is aware of their role
in the local decision
process but cannot
describe what others
do.
Deals with queries relating
to their role only but
knows who in the
department deals with
other aspects of a study
and can signpost people
effectively.
Can identify and handle
queries relating to their
role, understand wider
queries and issues and
effectively resolve issues
in the decision process
where required.
Manages the decision
process as a whole,
ensuring it is
proportionate to risk and
seeks continuous
improvement and
simplification.
C1.3 Regulatory
submissions.
Is unable to advise
or assist with
regulatory
submissions.
Is aware of the
process for regulatory
submission. Is unable
to provide assistance
but can signpost
people to help.
Is able to advise and assist
researchers with the
completion of regulatory
submissions.
Is able to develop
training and support for
researchers on the
regulatory submission
process.
Ensures the team
supports researchers in
all aspects of the
regulatory submission
process.
13
Competencies for R&D staff – November 2013
Level
E
D
C
B
A
C1.4 Regulation and
Legislation.
Is unaware of the
regulations and
legislation that apply
to research.
Is aware that there
are regulations and
legislation that apply
to research but
cannot describe the
requirements in
general terms.
Is aware of the need for
legal and regulatory
compliance (in particular
CTIMPs, HTA, DPA, role of
Caldicott guardian, MCA,
IRMER and ARSAC) and is
able to describe in broad
terms what is required.
Is able to apply the
appropriate regulations
and legislation
pragmatically and
proportionately to their
work.
Advises others on
appropriate legislation
and regulations
applicable to their
research and is confident
in challenging
inappropriate or
unnecessary application.
C1.5 Awareness of
Regulatory Bodies in
research.
Is unaware of the
existence of
regulatory bodies.
Is aware of regulatory
bodies but not what
they do and/or why.
Is aware of regulatory
bodies and their role.
Understands the role of
regulatory bodies, how
applications are made
and the requirements
for approval.
Works effectively with
regulatory bodies
including ethics and
MHRA, is confident in
understanding their
requirements and roles
and is able to advise staff
appropriately.
C1.6 Research
Management and
Governance systems
(IRAS, CSP, NIHR
Portal, local research
management system).
Is unaware of the
research
management and
governance systems
and databases used
by R&D.
Uses research
management and
governance systems
within their role.
Uses research
management and
governance systems
pragmatically and
proportionately within
their role and can run
reports from the systems.
Understands research
management and
governance systems and
can explain their use to
others.
Fully understands and
actively promotes the
use of research
management and
governance systems and
explores their strategic
use in supporting the
management of research
activity and reporting
metrics.
14
Competencies for R&D staff – November 2013
Level
C1.7 Research in the
NHS – HR Good
Practice Resource Pack
(Research Passport
System).
E
Is unaware of the HR
Good Practice
Resource Pack.
D
C
B
Is aware of the HR
Good Practice but is
not part of their role.
Is able to operate the HR
Good Practice Resource
Pack system effectively
and is able to escalate
issues where necessary.
Is able to advise and
guide others on all
aspects of the HR Good
Practice Resource Pack.
A
Deals with escalated
problems associated with
wider HR contractual
processes.
C2. Understanding the principles of Good Clinical Practice and Good Research Practice within R&D
C2.1 Good Clinical
Practice (GCP) and
good research
practice.
Is unaware of the
principles and
requirements of GCP
and good research
practice..
Is aware of the
principles and
requirements of GCP
and good research
practice but does not
understand their
application.
Understands the principles
and requirements of GCP
and good research
practice and how they
apply to different studies
i.e. GCP is a legal
requirement for regulated
clinical trials.
Understands all the
principles and
requirements of GCP
and good research
practice and promotes
training and adherence
as applicable.
Challenges poor practice
according to GCP and
good research practice
principles and
requirements and
recommends and secures
the necessary
improvement.
C2.2 Adverse Event
Reporting.
Is unaware of
adverse event
reporting.
Is aware of adverse
event reporting but
unsure of the
process.
Is aware of adverse event
reporting and able to
handle basic queries about
the reporting of adverse
events.
Is able to handle queries
about the reporting of
adverse events and can
administer the process
for reporting adverse
events.
Acts and advises on the
process and
requirements for adverse
event reporting.
C2.3 Breaches of Good
Clinical Practice (GCP).
Is unaware of GCP.
Is aware of GCP but
unsure of the process
Is aware of GCP and able
to handle queries about
the reporting of GCP
Is able to handle queries
about the reporting of
GCP breaches and can
Is able to act and advise
on the requirements of
reporting GCP breaches
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Competencies for R&D staff – November 2013
Level
C2.4 Training for
researchers.
E
Is unaware of the
different training
requirements for
different types of
research studies.
D
C
B
A
relating to breaches.
breaches.
administer the process
for reporting GCP
breaches.
and can secure the
necessary improvement.
Is aware that
different types of
training requirements
may be needed but is
unsure about the
detail.
Is able to identify different
training requirements for
different types of research
studies and can
recommend options.
Is able to promote
appropriate training and
ensure its delivery for
appropriate staff.
Is able to provide advice
on, source and/or deliver
training on good research
practice.
Understands the roles and
responsibilities of their
organisation as a sponsor
and/or host and is able to
apply them to their role.
Is able to advise others
on the roles and
responsibilities of
sponsor and hosts.
Is confident in
challenging inappropriate
delegation of roles and
responsibilities and any
breaches of sponsor and
host roles and
responsibilities.
C3 Understanding Research Responsibilities and Roles
C3.1 Roles &
Responsibilities of
Sponsors and Hosts.
Is unaware of the
roles and
responsibilities of
sponsors and hosts.
Is aware of the roles
and responsibilities of
sponsor and hosts
and that they are
different but does not
apply them in their
role.
16
Competencies for R&D staff – November 2013