Research Quality & Regulatory Affairs Officer, Grade Vi

Research Quality & Regulatory Affairs Officer, Grade VI

Purpose of the Role:

Children’s Health Ireland is Ireland’s largest paediatric hospital and the leading centre in Ireland for the conduct of clinical trials and studies in children. Clinical research is essential to provide an evidence base for improved medicines and treatment of sick children.

The QRAO is a supporting role for research at CHI. To ensure the delivery of high quality and safe clinical research, quality must be embedded throughout all research activities. As part of the Research Team, they will provide specialist skills and expertise in paediatric regulatory affairs and quality management in clinical research. One of their key responsibilities is to support the ongoing development and implementation of a Quality Management System (QMS) to ensure that all research activity is conducted in accordance with Good Clinical Practice (GCP) guidelines and all relevant legislation and quality standards. As the integration of the clinical research infrastructure progresses, they will support the alignment of processes across sites and rollout of a CHI wide QMS for research.

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As part of ongoing capacity building and strengthening of CHI’s clinical research infrastructure, we are now recruiting a Quality and Regulatory Affairs Officer. The role will provide key support to research teams and will ensure that all research studies are conducted in compliance with Good Clinical Practice (GCP) standards and all applicable legislative and regulatory requirements.

This is a new role within CHI and an exciting opportunity for a highly motivated candidate to work in a rewarding and developing area.

Essential Criteria:

Third level qualification in quality, clinical or life science related subject.

Minimum of three years’ experience in quality assurance and/or regulatory affairs in the biomedical or pharmaceutical industry, or a related healthcare environment.

Understanding of current Irish medical, academic and health services research environment and knowledge of the regulatory and legislative requirements relating to the conduct of clinical research.

Knowledge or experience in the preparation of clinical trial regulatory submissions to competent authorities and ethics committees.

Experience in quality assurance/quality control and/or quality management systems in a healthcare or regulatory environment.

Understanding of the role of academic study Sponsor, including Sponsor pharmacovigilance requirements.

Ability to communicate effectively and in a professional manner.

Excellent written and verbal communication, interpersonal, analytical and negotiation skills.

An individual with initiative and good judgement, capable of problem solving and working independently.

Proven project management and organisational skills.

Team player with the ability to mentor colleagues and promote a positive learning environment.

Thorough knowledge of Good Clinical Practice and of relevant national and international clinical trial regulations.

Strong planning and organising abilities.

Versatility and ability to work to tight deadlines and regulatory timeframes.

How to Apply & Informal Enquiries:

Applications for this post must be accompanied by a cover letter, setting out relevant experience that illustrates how the essential criteria listed above is met.

The criterion for short listing is based on the requirements of the post, as outlined in the eligibility criteria.

• Please note that you must submit a cover letter with your CV, this forms part of your application and CV’s will not be accepted without a detailed cover letter.

The closing date for submissions of CV’s and cover letter is 4th December 2024 by 11:45 p.m. Applications must be completed through the advertised post on CHI.jobs by clicking ‘Apply for Job’.

Applications will not be accepted through direct email or any other method.

For informal enquiries for this specialty/department, please contact rio@nchg.ie

For other queries relating to this recruitment process, please contact recruitment@nchg.ie