Post Title:
Quality and Regulatory Affairs Manager (QRAM), Health
Research Board Clinical Research Coordination Ireland
Post Status:
Six year fixed term contract from date of appointment
Organisation:
Molecular Medicine Ireland
Location:
Molecular Medicine Ireland, Newman House, 85a St. Stephens
Green, Dublin 2, Ireland
Reports to:
Chief Operations Officer HRB CRCI and HRB CRCI Chair
Salary:
Negotiable
Closing Date:
No later than 12 Noon (GMT) on 19 May
Application Process
Curriculum Vitae and covering letter containing names of 3
referees
to
be
sent
to
Fionnuala
Keane
at
info@molecularmedicineireland.ie
POST SUMMARY
With the support of Health Research Board, Enterprise Ireland and Molecular Medicine
Ireland, the five University-based Clinical Research Facilities/Centres (CRFs/Cs) in the
Republic of Ireland are developing an integrated clinical trials network, the Health Research
Board Clinical Research Co-ordination Ireland (HRB CRCI).
The aim of the HRB CRCI is to enhance Ireland’s capacity for conducting innovative high
quality clinical research for the benefit of people’s health and the economy. It will advance
the care of patients by enabling a connected and coordinated Clinical Trial Network. This
network will provide the skills, expertise and infrastructure to design, conduct and analyse
multi-centre clinical trials involving human participants in Ireland. It will support both
academic or industry initiated clinical trials involving pharmaceuticals, nutriceuticals or
clinical care pathways as well as the clinical investigation of medical devices.
The HRB CRCI now wishes to appoint a Quality and Regulatory Affairs Manager (QRAM)
(QRAM) to implement the quality elements of the agreed HRB CRCI 5 year business plan.
The position is for a high-calibre experienced candidate to deliver the quality elements of the
HRB CRCI’s 5 year business plan working in close collaboration with the HRB CRCI Chief
Operations Officer (COO), the HRB CRCI Chair and the HRB CRCI team both in the central
office and at a local level.
The HRB CRCI QRAM position will be funded by the Enterprise Ireland grant award for the
implementation of the HRB CRCI. The successful candidate will be based within the central
office of the HRB CRCI at Molecular Medicine Ireland and will travel to the CRF/C’s, sites
and other locations when necessary to carry out their duties. The HRB CRCI QRAM will
report to HRB CRCI COO and to the Chair of the HRB CRCI. The employment and HR
policies of Molecular Medicine Ireland will apply to the employment of the successful
candidate.
Key tasks and deliverables
The HRB CRCI Quality and Regulatory Affairs Manager (QRAM) will:















Take the lead on the development of Standard Operating Procedures (SOP’s) for the
HRB CRCI for its own central activities and for its service delivery to ensure that
activities carried out within the HRB CRCI are conducted in accordance with GCP
guidelines, local legislation and the Clinical Trials Directive where appropriate
Assist in coordinating the national Quality and Training work force across the CRF/C’s
Advise on the interpretation of complex legislation relating to clinical research,
identifying the implications for HRB CRCI operations and acting to initiate necessary
changes to practice in order to ensure that the HRB CRCI remains compliant with
statutory regulations
Provide professional advice relating to the regulation, management and conduct of
clinical research
Assist in the development of submission documentation (i.e. protocol, patient
information sheet and consent) for companies, organisations or individuals that do not
have such services available locally.
Be responsible for sign off on all HRB CRCI regulatory and ethics submissions.
Oversee all web portal resource content for HRB CRCI prior to uploading
Coordinate clinical trial submissions to the relevant competent authorities for
companies, organisations or individuals that do not have such services available locally
Be experienced in site auditing and monitoring, and develop and implement an auditing
and monitoring service for the HRB CRCI
Provide guidance on mandatory research training (GCP, Medicines for Human Use
(Clinical Trials) Regulations, etc.)
Work with the HRB CRCI COO in liaising with university and hospital ethics and
approval committees to work to improve hospital and ethical approval processes
nationally
Coordinate the development and implementation of a long-term HRB CRCI Quality
Management System in order to ensure that the HRB CRCI maintains a system of
continuous quality improvement that meets the requirements of evolving clinical
research legislation
Assist and input into the development of progress and grant reports for the HRB CRCI
Participate as HRB CRCI ECRIN-ERIC observer when required
Carry out any other duties that arise during the ambit of the post
Requirements








Degree level qualification in a clinical or life sciences related subject
A minimum of 5 years of experience in quality assurance in the biomedical or
pharmaceutical industry
Understanding of current Irish medical, academic and health services research
environment
Knowledge of GCP and of relevant national and international clinical trial regulations
Experience in GCP training
Experience within a commercial/academic clinical research environment
Clinical trial monitoring and auditing experience
Proven project management and organisational skills





Experience in developing quality strategies
Excellent communication skills (oral, written & presentation) with proven ability to work
effectively as part of a team.
Strong leadership and communication skills
Self-motivated and able to work independently, showing initiative and good judgment.
Good IT skills
It would be desirable that post holder would have:

Master’s degree in clinical or life science related subject
Competencies:








Leadership
Initiative
Ability to work well in a team
Excellent interpersonal and communication skills
Ability to meet deadlines and work under pressure
Problem analysis and resolution skills
Ability to effectively communicate the vision and values of the HRB CRCI
Excellent planning and organising abilities
An applicant must be an EU citizen or be from outside the EU with permanent Irish resident
status or a valid work permit.
MMI is an equal opportunities employer
Post Title:
Clinical Trials Liaison Officer, CTLO, Health Research Board
Clinical Research Coordination Ireland
Post Status:
Five year fixed term contract from date of appointment
Organisation:
Molecular Medicine Ireland
Location:
Molecular Medicine Ireland, Newman House, 85a St. Stephens
Green, Dublin 2, Ireland
Reports to:
Chief Operations Officer HRB CRCI and HRB CRCI Chair
Salary:
Negotiable
Closing Date:
No later than 5:00 pm (GMT) on Tuesday 19 May 2015
Application Process
Curriculum Vitae and covering letter containing names of 3
referees to be sent to info@molecularmedicineireland.ie
Clinical Trial Liaison Officer, CTLO, HRB CRCI, Job Description
HRB CRCI Background:
With the support of Health Research Board, Enterprise Ireland and Molecular Medicine
Ireland the five University-based Clinical Research Facilities/Centres (CRFs/Cs) in the
Republic of Ireland are developing an integrated clinical trials network, the Health Research
Board Clinical Research Co-ordination Ireland (HRB CRCI).
The aim of the HRB CRCI is to enhance Ireland’s capacity for conducting innovative high
quality clinical research for the benefit of people’s health and the economy. It will advance
the care of patients by enabling a connected and coordinated Clinical Trial Network. This
network will provide the skills, expertise and infrastructure to design, conduct and analyse
multi-centre clinical trials involving human participants in Ireland. It will support both
academic or industry initiated clinical trials involving pharmaceuticals, nutriceuticals or
clinical care pathways as well as clinical investigation of medical devices.
The HRB CRCI now wishes to appoint a Clinical Trial Liaison Officer.
The position is for a high-calibre experienced candidate to deliver the HRB CRCI Clinical
Trial support services as per the HRB CRCI’s 5 year business plan working in close
collaboration with the HRB CRCI Chief Operations Officer, the HRB CRCI Chair and the
HRB CRCI team both in the central office and at a local level.
The HRB CRCI Clinical Trial Liaison Officer position will be funded by HRB funding award
for the implementation of the HRB CRCI. The successful candidate will be based within the
central office of the HRB CRCI at Molecular Medicine Ireland will travel to the CRF/C’s, sites
and other locations when necessary to carry out their duties. The HRB CRCI Clinical Trial
Liaison Officer will report to the HRB CRCI COO and to the Chair of the HRB CRCI. The
employment and HR policies of Molecular Medicine Ireland will apply to the employment of
the successful candidate.
Key deliverables:
The HRB CRCI Clinical Trials Liaison Officer will:













Provide professional advice and support relating to the regulation, management and
conduct of clinical research in Ireland
Assist in the development of submission documentation (i.e. protocol, patient
information sheet and consent) for companies, organisations or individuals that do not
have such services available locally
Assist in the coordination of clinical trial submissions to the relevant ethics and
competent authorities for companies, organisations or individuals that do not have such
services available locally
Be experienced in site monitoring and carry out site monitoring services for the HRB
CRCI
Be responsible for the development of the HRB CRCI feasibility delivery SOP
Be the primary point of contact between the HRB CRCI, the investigators, the sites and
the CRF/C’s for the implementation of the HRB CRCI feasibility processing system
Be the primary point of contact for industry for the HRB CRCI feasibility delivery service
Work with the sites and HRB CRCI staff at the CRF/C’s on the efficient delivery of
investigator and site selection
Work with the sites and HRB CRCI staff at the CRF/C’s on the efficient delivery of study
start-up and first patient first visit timelines
Be responsible for the delivery of the HRB CRCI trial management services including
signposting services for study specific requirements such as IMP management,
pharmacovigilance, data management services etc.
Be responsible for information gathering from site for the purpose of recruitment
tracking, study/trial development and progress monitoring and reporting
Assist and input into the development of progress and grant reports for the HRB CRCI
Carryout any other duties that arise during the ambit of the post
Requirements:










Degree level qualification in a clinical or life sciences related subject
A minimum of 5 years of experience in biomedical or pharmaceutical industry
Understanding of current Irish medical, academic and health services research
environment
Knowledge of ICH GCP and of relevant national and international clinical trial regulations
Experience within a commercial/academic clinical research environment
Proven project management and organisational skills
Excellent communication skills (oral, written & presentation) with proven ability to work
effectively as part of a team.
Strong leadership and communication skills
Self-motivated and able to work independently, showing initiative and good judgment.
Good IT skills
Competencies:


Leadership
Initiative






Ability to work well in a team
Excellent interpersonal and communication skills
Ability to meet deadlines and work under pressure
Problem analysis and resolution skills
Ability to effectively communicate the vision and values of the HRB CRCI
Excellent planning and organising abilities