National Office for Research Ethics Committees

Permanent full-time position

HRB Grade VII Job Family (consisting of R&I IV, Services IV & Research Officer grades).

 

Background

The National Office for Research Ethics Committees (National Office) is a business unit within the Health Research Board (HRB), with a statutory function in the regulation of health research (www.nrecoffice.ie) and works under the auspices of the Department of Health. The primary function of the National Office is to support a robust and transparent system of National Research Ethics Committees (NRECs), which provide robust and timely ethics assessment of regulated research studies to ensure the safety, dignity and wellbeing of research participants. The NRECs adhere to international best practice and the highest standards in research ethics review to protect the safety, dignity and well-being of research participants

Established in 2021, the NRECs are mandated under legislation, to return ethics opinions that are respected nationally (‘single national ethics opinion’) and specifically to meet Ireland’s Member State obligations under the Medical Devices Regulation (MDR: EU No 2017/745) , the In Vitro Diagnostic Medical Devices Regulation (IVDR: EU No 2017/746) and Clinical Trial Regulations (CTR: EU No 536/2014).

The Committees we support and areas of research that fall under the remit of these committees are:

  • National Research Ethics Committee for Medical Devices (NREC-MD) for clinical investigations of medical devices and performance studies of in vitro diagnostic medical devices,
  • National Research Ethics Committee for Clinical Trials (NREC-CT; A, B, C, D) for Medicinal Products for Human Use,

Currently, the National Office supports approximately 100 members across these five committees. Following a restructuring in January 2024, there are four NRECs for clinical trials for medicinal products (NREC-CT A, B, C, D) and constituted in total with just over 70 members. In 2025, the NREC-CTs delivered 111 opinions on new clinical trial study applications and 311 opinions on substantial modification applications, over the course of 49 meetings.

The CTR has introduced complex assessment process for Member States, such that it defines two parts of a clinical trial application dossier:

  • Part I: a coordinated scientific assessment of the trial (Investigator brochures, protocols etc) by the Reporting Member State (RMS) RMS and all Member States Concerned (MSCs).
  • Part II: an ethical assessment of country-specific and site-specific documents by each MSC according to its own national requirements

The National Office receives applications for ethics approval on behalf of the NRECs and supports the Committees’ independent ethics review processes. Sponsors of clinical trials conducted under the Clinical Trials Regulation, must submit ethics applications for assessment, through the pan-European online portal Clinical Trial Information System (CTIS), which the National Office interfaces with.

The mission and vision for the National Office team is to ensure the national research ethics system is sustainable, agile and has capacity within a fast-evolving regulatory research landscape in Ireland and across Europe. Core to this mission is to ensure the National Office represents Ireland and its ability to meet the regulatory requirements under the European Union (EU) Regulations, in line with other EU member states.

 

Key responsibilities of the Programme Officer (NREC-CT) post

A vacancy has arisen in the National Office and the HRB is now seeking to recruit a permanent full time Programme Officer to the National Office support the NREC-CTs and the clinical trial application portfolio.

The Programme Officer role within the National Office is a key enabler in supporting the NREC-CTs to deliver high-quality ethics opinions on the complex scientific and technical aspects of clinical trial studies.

The Programme Officer will work closely with their fellow clinical trials Programme Officer and management within the National Office to ensure consistency of operations and strategic alignment for all work related to the clinical trials portfolio. They will primarily support two of the four NREC-CTs in the course of committee business, to deliver a single national ethics opinion for clinical trials, in accordance with EU legislative timelines.

This role integrates several strands of the National Office agenda under the CTR including committee operations and training, CTIS operations, and EU representation on associated working groups and other related fora. The appointed individual will occupy a high visibility role in relation to the NREC system’s work in the CTR environment and will have to coordinate the input of others, both internally and externally, in the execution of their role.

This role is crucial to ensure the work of the NREC-CT is supported to meet the CTR requirements operationally, including the committees’ ethics assessment of ‘Part I and ll’ of clinical trial application dossier where appropriate, in both the ‘reporting member state’ and ‘member state concerned’ scenarios. This support includes providing expertise on the technical content of clinical trial protocols, Investigator Brochures, and other supporting documentation.

The Programme Officer will retain a skilled familiarity with the clinical trial dossier format under the CTR including the requirements for NREC-CT input into Part II and where appropriate, Part I components. The Programme Officer will take a lead role in interfacing with the new EU portal, the Clinical Trial Information System (CTIS), on behalf of the NREC system for Part I, and liaising with the national competent authority, the Health Products Regulatory Authority (HPRA), to ensure the coordination and organisation necessary to deliver an Irish ‘single national decision’ on clinical trials in line with the CTR.

The role will involve working in close partnership with colleagues in the HPRA, forming a critical collaborative relationship that ensures a coordinated national approach and effective representation of Ireland within the EU clinical trials framework.

The Programme Officer will support the ethics assessment of safety notifications and serious breach notifications as they may arise, including coordinating the NREC Safety Committee and liaising with the HPRA assessment and inspections teams as necessary.

The National Office will be preparing for the forthcoming European Biotech Act which will bring important amendments to the CTR, including a reduction in clinical trial assessment timelines by one third. The Programme Officer will work closely with the National Office management team to develop robust policies and procedures to support the NREC-CT and their work in preparation for future legislative amendments under the Biotech Act as required.

The Programme Officer will lead on the development, implementation, and continuous improvement of (SOPs) within the National Office, with a focus on clinical trials. Drawing on their subject matter expertise and operational experience, they will be responsible for designing and maintaining procedures that ensure consistency, quality, and compliance across all aspects of the Office’s work. This includes translating legislative requirements, regulatory guidance, and best practices into clear and practical processes that support decision-making and service delivery. Duties will include:

The Programme Officer will play a leading role in the design, development, and implementation of a comprehensive training programme to support the onboarding of new Committee members and National Office team members.

The Programme Officer should be able to multi-task and manage a varied workload, including but not limited to the following:

Operations under the CTR and CTIS

  • Act as the National Office main point of contact for the HPRA in relation to Part I dossier assessments and safety notifications.
  • Support the delivery of CTIS actions include completion of subtasks raised by the HPRA, uploading considerations from the NREC, consolidating considerations when reporting member state, completing relevant sections in the Draft Assessment report (DAR).
  • Work with National Office team to resolve any queries or challenges raised by other Member States related to the NREC-CT assessment of Part I.
  • Keep abreast of CTIS development and deliver training on the CTIS to ensure that a current and sufficient proficiency is embedded across the National Office team;
  • Work with National Office team to ensure coordination of timelines for NREC meetings and deadlines within the CTIS.
  • Monitor notifications (i.e., serious breaches, adverse events, urgent safety measures) and ad-hoc assessments (i.e., review of such events) submitted to the CTIS.
  • Assist with facilitation of NREC-CT comments for Part II assessment of new trials and substantial modifications;
  • Prepare accurate and succinct review summaries of Part I documentation to facilitate review by the NREC-CT;
  • Coordinate the contribution of NREC-CT comments for Part I assessment for new trials and substantial modifications, and analyse and consolidate comments where necessary from other MSCs;
  • Respond to queries related to CTR and CTIS
  • Regular review of processes related to CTR and CTIS

Supporting NREC ethics assessments

  • Attend NREC-CT meetings to ensure an informed and accurate understanding of the committees’ views, and requests where relevant, relating to the applications under their review;
  • The Programme Officer will support NREC-CT members with specialist scientific, technical, and regulatory expertise in the assessment of the Part I information.
  • Coordinate the contribution of NREC-CT comments for Part I assessment for new trials and substantial modifications, and analyse and consolidate comments where necessary from other MSCs;
  • Support and drive the ethics assessment of safety notifications when required, utilising the skillset of the newly established NREC Safety Committee.
  • Work with the HPRA on the implementation of corrective measures arising from GCP inspections, as requested.
  • Lead on the redesign of National Office support functions for the NREC-CTs, developing required SOPs and training the wider team to effectively implement these new processes and responsibilities.
  • Liaise with the NREC Safety Committee, in relation to committee notifications on safety and corrective actions, to ensure appropriate measures are taken on behalf of the NREC-CT.
  • Support the NRECs in assessing combined regulated studies, involving both medicinal products and medical devices, in collaboration with the National Office team supporting the NREC-MD

General National Office responsibilities

  • The Programme Officer will assume a ‘resident CTR expert’ role and represent the NREC-CT and the National Office on key national and international fora in relation to NREC system operations under the CTR
  • Support the National Office’s participation in EU4Health Joint Action ‘FACT-EU’ programme that support the harmonised implementation of the CTR with EU Member State counterparts.
  • Support and enable the Programme Managers to continue to engage with critical EU working groups (MedEthicsEU, ACT EU – Accelerating Clinical Trials in the EU )
  • Foster strategic connections with research ethics counterparts across the EU to understand emerging best practice in relation to research ethics committee operations under the CTR;
  • Lead on the development of SOPs for clinical trial assessment processes
  • Support the development of formal onboarding training for team members and committee members
  • Actively engage with EU working groups involved in harmonising clinical trial application processes.
  • Act as a source for international and European harmonised guidance and best practices for clinical trial methodologies to support the team and NREC-CTs, as required.
  • Maintain a working knowledge of the other legislation, regulations and guidelines pertaining to the environment for conduct of clinical trials and support the team and NREC-CTs in understanding;

 

Essential knowledge and experience

Formal requirements include:

  • A NFQ Level 9 Qualification (Masters Degree/Postgraduate Diploma) is required as a minimum, a NFQ level 10 (Doctorate) is desirable in a relevant field (biomedical sciences, the healthcare professions, law, and ethics)
  • At least five years’ appropriate professional experience in academic, health research bodies, governmental, commercial or not-for-profit health and social care research setting.
  • Strong working knowledge of clinical trials research, methodology and associated scientific knowledge, health research ethics and governance, national and European health research regulations and legislation, including the CTR.
  • High degree of computer literacy, including knowledge and experience of using Microsoft Word, Excel, Outlook. Experience of databases and on-line application systems would be a distinct advantage
  • Working knowledge of the national health research system, and of the Irish academic and health services environment would be a distinct advantage
  • Working knowledge research ethics and experience of managing an ethics committee or similar committee would be a distinct advantage

Additional desirable experience will include the following:

  • Knowledge of the Clinical Trials Information System
  • Ability to manage and coordinate interdependent and cross-functional teams
  • Ability to lead, be a strategic thinker and deliver operational excellence
  • Ability to deliver with quality under strict legislative timelines
  • Strong interpersonal and communication skills and ability to deliver training
  • Analysis, critical thinking, problem solving and decision making
  • Ability to communicate, network and influence people and expert groups
  • Ability to manage competing deadlines and priorities across multiple work areas
  • A high degree of motivation and resilience
  • A high level of professional integrity, ethics and strong public service values and accountability

 

Key competencies include:

  • Effective influencing and negotiation skills
  • Proficient writing and communication skills
  • Be a driver of results, meeting deadlines and managing competing and changing priorities
  • Coordination of the input of others cross-organisationally and externally
  • A high degree of motivation and professional integrity
  • An ability to exercise confidentiality and discretion

 

Competencies

Competencies incorporated into this role profile reflect the competency framework issued in conjunction with the Civil Service Competency Framework which has been adopted by the HRB.  A comprehensive list of expected competencies can be found here.

 

Reporting relationship

The role of Programme Officer report to a Programme Manager, National Office for Research Ethics Committees.

 

Salary scale

Salary Range for Programme Officer – NREC (Grade VII)                   €61,219 to €79,583

Note:  Programme Officer, permanent, full-time position

Appointment will be made in accordance with the Department of Health guidelines. New entrants to the public service will be appointed at the first point of the scale

 

How to apply

Please submit a cover letter and curriculum vitae by email to recruitment@hrb.ie.  You must include the name of the post that you are applying for in the email subject line.

Closing date for applications is Noon on 6 October 2026.

NOTE: Interviews are expected to be held at the HRB offices towards the end of October and the beginning of November.

 

 

If you require further information, please contact Ruth Bourke, HR Generalist at recruitment@hrb.ie or please refer to the Recruitment page on the HRB website at http://www.hrb.ie/about/recruitment/  for full details on this campaign.

The Health Research Board is an equal opportunities employer and welcomes applications from all sections of the community. We do not discriminate based on gender, age, race, religion, marital status, sexual orientation, disability, membership of the Travelling community or family status. If you have a disability and require accommodations to be made during the recruitment process, please contact HR in advance and we would be happy to assist.