MMMMMMMMM

Maximising the potential of the

clinical research nurse workforce

to promote research and

innovation

Gail Woodburn – Lead Nurse Research and Innovation

Janette Dunkerley – Clinical Research Nurse Manager

Clinical Research Nursing at CMFT

• Who are we?

• What do we do?

• How and why we

do it well

Who are we?

‘Nurses employed principally to

undertake research within the

clinical environment’

(UKCRC subcommittee for nurses in clinical

research

(workforce) page 32)

‘Undertake work associated with the

efficient and successful conduct of clinical trials’ (Johnson & Stevenson 2010)

Historically BENEFITs

• Travelling to investigator meetings and conferences nationally and

internationally

• Eating at good restaurants to discuss the research project/s and to network

• No shift work

AN INVISIBLE- HARD TO REACH GROUP

• Frequently working in isolation – NO-ONE KNOW’s WHERE WE ARE

• Drowning in a sea of research jargon

• Often viewed just as a data collector

• Short term contracts with ad hoc funding

• Sometimes have to arrange holidays around studies in progress

• No employment rights/career progression

What do we do?

• Study Preparation

– reviewing protocols for key elements of nursing care, risk, patient safety issues

– Carrying out literature reviews

– Contributing to ethics submissions

• Research Conduct

– Patient recruitment and enrolment

– Ensuring protocol compliance

– Data collection and management

• Clinical expertise

– Patient assessment

– Co-ordination of patient treatment and patient/family/staff support

• Education

– Gaining informed consent

– Providing education about the research/trial to patient, family and staff

• Management

– Budgets

– Trial co-ordination, management and liaison

– Involvement in multi-disciplinary team meetings and research related committees

The CMFT Experience

• One of only a few Trusts nationally to have a leadership

and management structure in place to support clinical

research nursing (similar model now in place for

research support staff)R&I Organogram

• Centrally employ Clinical Research Nurses through the

R&I division, developing teams of nurses to work

flexibility across studies

• Clear lines employment and professional

accountabilityAccountability Framework

• Clinical Research Nurse Development Framework in

place - induction through to leadership and management

development

• Various models of providing research nurse expertise

– Support for studies run through CRFs

– In reach

– Out reach

– Support for studies run in CMFT

• Career pathway in development – many more opportunities, improved access to CPD opportunities

• Hub and spoke approach to providing student nurse placements – now being developed into multi-professional placement hub

• We do new and exciting things

Successes

• CLRN Nurse of the year award for impact on recruitment

• Highest recruiting Trust in Greater Manchester and

second Nationally (2013/14)

• Host GMLCRN – professionally responsible for CRNs

• Advanced Practitioner roles in research – first in the

country

• Nurses taking informed consent on CTiMPs

• Research nurses care pledge – values and behaviours

work

• Regional and national work

Advanced Practitioner role

• First in the Country

• Lead on participant care for the duration of a study, including assessment for inclusion in a study, medical history taking, medical examinations, management of drug infusions, prescribing and reviewing and refining participant care throughout the study

• Demonstrate enhanced clinical skills including arterial bloods, biopsies, management of central lines, minor surgical procedures, ultrasound in the vascular system, management of anaphylaxis, pulse wave analysis, analysis and decisions relating to test results and ealry warning scores

• Provide clinical leadership to the team of nurses, focusing on enhanced practice development

Consent on CTiMPs

• Organisational support

• Policies and procedures (SOP )

• Be at least band 6 practitioners with experience of taking informed

consent on non-CTiMPs and/or experience of working on CTiMPs

• Be accredited NIHR GCP trained

• Have completed the half day in-house study day – ‘Seeking non-

medical consent on CTIMPs ’

• Be able to demonstrate and document competency through

observation and assessment

• Understand the specific trial protocol fully

• Recognise and practice within own limits and professional

boundaries

• Be able to demonstrate on-going competency through personal

portfolio

CMFT Nursing Strategy - Living the Values

Compassion

Dignity

Respect

Consideration

Empathy

Pride

Research Nurse Pledge - I promise I will…

Listen

Care and be sensitive to your needs

Be accommodating and flexible

Understand you and your situation

See you as a person and not as a patient

Treat you equally and not make assumptions

Be knowledgeable about the study in which you are taking part

explaining procedures clearly

Be well presented, polite and punctual

Be patient

Be prepared and organised

Has the research nurse kept the

promise of this pledge today?

100% said yes

Do you feel this pledge has had a positive impact on your care?

96% said yes

Accountability Framework

Medical

Director

Chief Nurse

Head of

Division R&I

Team leader/Clinical Research Nurse Manager

Clinical Research Nurse

PI

Director of Nursing

Divisional

Director R&I

Lead Nurse

R&I Lead Nurse R&I

Professional Accountability Research Accountability

R&I Organogram

Clinical Research Nurse Manager - 8A

Emerging

Band 7 x2

Rheumat

Band 7

Renal

Band 7

Gynae

Band 7

MHC

Band 7

CVTU/Diabe

tes

Band 7

Adult

Oncology

Band 7 X 1

BAND 6

POSTS

Sexual health

(2)

Immunology

Endocrinolgy

Opthalmology

Surgery (2)

Andrology

Band 6 X

3

Band 6 X

2

Band 5 X

1

Band 6 X

6

Band 6 X

3

Band 6 X

5

Band 5 x 1

Band 6 X

5

Adult CRF

Band 7 X 3

Band 6 X

13

Band 5 X 4

Band 4 X 1

Band 3 X 1

Band 2 X 1

Band 6 X 4

RENAL

Band 7

Specialist

post

Lead Nurse 8B

Adult Advanced

Practitioner

Paediatric Advanced

Practitioner

LCRN

Lead Nurse – 8A

CCRF (B6/B5/B4/B2)

Paediatric Oncology/LCRN

Nurses

MCRF Clusters

Emerging

Kellgren

Sex. Health

(2)

Adult Oncology

Gastro (1) - outreach

Haematology (1) - outreach

Surgery (1)

Ophth. (1)

Renal

MHC

CVTU

Diabetes

Endo. (2)

Paed.

Oncology

Genetics

Obs &

Gynae

Trust Teams