Mater Misericordiae University Hospital Dublin

Mater Misericordiae University Hospital
Dublin
Post Information Job Title / Grade: Research Nurse CNM1
Post Title
Clinical Research Nurse
Grade CNM 1
Applications are invited from suitably qualified candidates for a position as a Clinical
Research Nurse. This position will be based in the Clinical Trials Research Unit (CTRU),
Institute for Cancer Research, 48 Eccles Street.
The CTRU is a self-funding unit within the Cancer and Surgery Directorate of the Mater
Misericordiae University Hospital.
The CTRU aims to provide patients with a clinical trial option, thereby advancing treatment for
patients with cancer. The CTRU comprises both Oncology and Haematology Clinical Trials
across the Mater Campus with includes the Mater Private Hospital.
Department / Division: Clinical Trials Research Unit CTRU
Directorate: Cancer and Surgery Directorate
Location: Institute for Cancer Research, 48 Eccles Street
Reporting Relationship: Ms. Martina Smith CNM3 in the CTRU
Responsible to: Prof John McCaffrey, Clinical Director, CTRU
Purpose of Post
The successful candidate will work as part of a multi-disciplinary team who engage with
researchers and clinicians to support clinical research within the CTRU.
Within the remit of this post, the successful individual will have responsibility for a caseload of
patients on clinical trials and research projects. The individual will be expected to lead under
direction of the Clinical Director and CNM3 in areas such as audit and staff education and to
make an important contribution to papers arising from studies undertaken by the CTRU. The
Job Description, Clinical Research Nurse, CTRU, Version 3.0 Jan 2017
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Clinical Research Nurse will support the ongoing strategic development of the CTRU in
expanding our service to include selected phase I clinical trials.
Mandatory
Must be registered with the general division of An Bord Altranais
Have a minimum of 5 years post registration experience
Hold a recognised Post graduate Oncology/Haematology Nursing course
Prior experience in nursing care of patients participating in clinical trials
Have Proven Clinical skills
Have excellent oral and written communication skills
Have good organisational and ‘problem solving’ skills
Have the management and interpersonal skills required to integrate as part of a
diverse research team and work as part of a multi disciplinary team
Have good IT skills including Microsoft Office Suite
Competence in phlebotomy and cannulation procedures
Desirable
Prior ICH-GCP training
General Responsibilities
Report directly to CMN3 of the CTRU
Work in collaboration with the other members of the CTRU team and Consultant
Oncologist’s and Haematologists.
Ensure strict adherence to hospital policies and procedures
Ensure strict adherence to department standard operating procedures to ensure
protection of patient rights, interests and well being
Become a member of Cancer Trials Ireland and undertake training in Good Clinical
Practice (GCP)
Specific Responsibilities
Attend various Multi Disciplinary meetings to screen for potential patients for current
and upcoming clinical trials
Attend weekly ward rounds where participating and potential patients are discussed
with the oncologist’s and haematologists
Attend various requisite meetings including: weekly team meetings to prepare for the
week ahead, monthly strategic team meetings where current and future trials are
discussed
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Maintain documentation for screening potential patients, eligibility checklists and
enrolment checklists to ensure all required study related data is source verified in
compliance with the clinical trial protocol
Attend Investigator meetings as relevant
Attend site initiation meetings as relevant
Patient Management
Organise patient treatment schedules and ensure all required tests, procedures and
assessments are performed in accordance with the protocol requirements during
screening, treatment and follow up period
Discuss study participation with patients and their families ensuring the informed
consent process is adhered to
Educate patients and their families on treatment schedules, potential benefits and
side effects in accordance with clinical trial protocol
Enrol eligible patients to clinical trials in accordance with study protocol
Review participating patients in the oncology day wards at treatment visits ensuring
all protocol related assessments are conducted in compliance with the clinical trial
protocol
Ensure adherence to the clinical trial protocol with regard to dose modifications where
necessary
Review participating patients in study follow up at clinic visits ensuring all protocol
related assessments are conducted in compliance with the clinical trial protocol
Ensure blood and tissue samples are obtained, processed, stored and sent to central
facilities in accordance with patient consent and clinical trials protocol
Maintain stock control of Clinical trial supplies
Liaise with relevant Clinical Trial Associate (CRA) with regard to eligibility, scheduling
and protocol adherence queries ensuring all communication is saved both
electronically and in hard copy in the site file
Data Management
Ensure relevant information is acquired and documented during screening, treatment
and follow up visits to facilitate accurate data capture from clinical notes
Edit for errors in accordance with ICH GCP
Ensure for compliance with the obligations required by the Data Protection Act
Report and discuss Serious Adverse Event’s (SAE’s) with the PI in accordance with
the clinical trials protocol
Monitoring Visits: Be available to receive CRA’s and answer any queries that may
arise
Review and prepare the clinical notes for inspection during monitoring and audits
Training and Education
Attend Investigator meetings
Attend Site initiation meetings
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Read the Clinical Trial protocol and have a clear understanding of its objectives and
requirements
Read and be familiar with User Manuals for central laboratory blood and /or tissue
testing
Educate and train oncology/haematology nursing staff within the service on the
clinical trial protocol, the objectives and required procedures at study visits
Complete all training requirements on subject enrolment and data management using
electronic systems
Display evidence of continuing professional development
General Responsibilities and Accountabilities
1. Confidentiality
You will be aware of the confidential nature of Hospital work and in particular, the right of
patients to confidentiality.
2. Policies & Procedures
You are required to familiarise yourself with and adhere to all policy and procedural
documents relevant to your position.
3. Hygiene Standards
The highest standard of hygiene must be maintained in the Hospital at all times and all
staff members are responsible for ensuring compliance with the Hospitals requirements
and standards with regard to hygiene. It is the responsibility of all staff to have a
fundamental understanding of their individual responsibility in maintaining departmental &
site hygiene standards.
4. Health and Safety
Ensure that effective safety procedures are in place to comply not only with the Safety,
Health and Welfare at Work Act 2005 but also within the spirit of the Hospital’s mission,
vision and values, and they are known and followed by staff. You are required to
familiarise yourself with the requirements of employees under the Safety, Health and
Welfare at Work Act 2005 and to promote a work environment that is compliant with the
Safety, Health and Welfare at Work Act 2005. Each staff member is individually
responsible for ensuring that the Hospital remains a safe place to work.
5. Information Technology
Ensure the most effective and efficient use of developments in information technology for
administrative support in a manner, which integrates well with systems throughout the
organisation.
6. Business Continuity Management
Business Continuity Management (BCM) is a holistic management process that identifies
potential impacts that threaten an organisation and provides a framework for building
resilience and the capability for an effective response that safeguards the interests of its
key stakeholders and reputation” (BS 25999) All Staff employed in the Mater
Misericordiae University Hospital are obliged to:
- make themselves familiar with the Organisational BCM Policy
- attend BCM education sessions provided for them
- make themselves familiar with their individual roles as set out in their
departmental business continuity plan if applicable and or the Organisational
business continuity plan
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Note:
These duties and responsibilities are reflection of the present service requirements
and may be subject to review and amendment to meet the changing needs of the
Hospital. The incumbent CNM 1 will be required to maintain, enhance and develop
their professional knowledge, skills and aptitudes necessary to respond to a changing
climate. The job description must be regarded as an outline of the major areas of
accountability at the present time, which will be reviewed and assessed on an on-going
basis.
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