HRB Grade VIII Job Family (consisting of R&I II/ Researcher II / Service III grade)

 

Background

The Health Research Board (HRB) is a statutory agency under the aegis of the Department of Health. As the lead agency in Ireland responsible for supporting and funding health research, generating health information and promoting the use of evidence in policy and practice, we are motivated and inspired by our vision – healthy people through excellent research and applied knowledge. The Health Research Board’s (HRB) mission is to improve people’s health and enhance healthcare delivery.  The Health Research Board’s (HRB) mission is to support research that improves people’s health, promotes evidence-informed care and creates solutions to societal challenges. An overview of the HRB’s objectives and activities may be found in the HRB Strategy 2021-2025: Health research – making an impact (https://www.hrb.ie/strategy-2025/).

The National Office for Research Ethics Committees 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 competent and timely ethics assessment of regulated research studies to ensure the safety, dignity and wellbeing of research participants.

The NRECs are mandated under legislation, or by ministerial instruction, to return ethics decisions that are respected nationally (‘single national ethics opinion’) and specifically to meet Ireland’s requirements under the Medical Devices Regulation (MDR: EU No 2017/745) [1], the In Vitro Diagnostic Medical Devices Regulation (IVDR: EU No 2017/746) [2] and Clinical Trial Regulations (CTR: EU No 536/2014).[3]

Furthermore, the implementation of the Clinical Trial Information System (CTIS), the pan-European online portal also came into effect in January 2022, introducing a new and complex system for applications for regulated clinical trials to be submitted under the Clinical Trials Regulations (CTR).

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 100 members across these 5 committees. Following a restructuring in January 2024, there are now 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.

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 Regulations, must submit ethics applications for assessment, through the pan-European online portal Clinical Trial Information System (CTIS), which the National Office interfaces with. 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. 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 Project Officer (National Office, NREC-CT) post

The HRB is now seeking to a permanent full time Project Officer to support the processes and procedures underpinning a high-performing system for NREC-CTs in Ireland.  This role offers an exciting opportunity for suitably qualified candidates to join a busy team of dynamic and dedicated high-performing professionals whose core values of integrity, knowledge, collegiality and transparency drive their work of delivering an agile and trusted office in national public service.

The National Office team comprises Programme Managers, Programme Officers, Project Officers, a Project Administrator and Administrative Assistant, including a Finance and Communications Officer. The Project Officer role will be a critical enabler of the work of the National Office and backbone of the support provided the NREC-CTs and requires scientific, operational and technical expertise.

The Project Officers will play a central role in supporting the NRECs for Clinical Trials of Medicinal Products (NREC-CTs) in their independent reviewing of and decision-making for research ethics applications. They will work closely with the Programme Managers, Programme Officers and other Project Officers in supporting the entire clinical trials portfolio, management of all application dossier submitted to the Clinical Trials Information System (CTIS) and support the committee members in the delivery of all national ethics opinions for studies conducted in Ireland under the CTR.

The Project Officer role will play a key part in providing operational and technical support to the NREC Committee members, working with the Programme Managers, Programme Officers and Head of Office. They will be expected to support the overall work of the National Office including the technical and organisational requirements of the NREC-CTs and may from time to time be assigned other duties depending on business needs.

The post will be assigned to support the Clinical Trials team within the National Office, with potential for assignment across other areas of the National Office also, as required. Project Officers should be able to multi-task and manage a varied and deadline driven workload,

 

Duties will include (but are not limited to) the following:

Supporting the NREC-CTs to deliver national ethics opinions

The Project Officer roles will provide operational support throughout the lifecycle of an ethics review application, from validation, requests for further information, and pre-review to post-review and NREC decision-making stage, to ensure timely and robust ethics review, and in particular, will be responsible for the following actions / activities:

  • Provide guidance and respond to queries from prospective applicants/sponsors
  • Champion a continuous improvement mindset and approach to processes within NREC-CT operations, to facilitate NREC members review and efficient application submission, including update of relevant application forms, checklists, FAQs etc
  • Organise NREC meetings, including liaising with members, meeting pack preparation and dissemination, and responding to member queries
  • Coordinate the preparation of ethics application dossier for NREC meetings
  • Develop an in-depth working knowledge of the Part I and Part II dossier assessment requirements, in accordance with the CTR and its mandated timelines
  • Work closely with NREC members to finalise opinions for initial clinical trial applications and substantial modifications submitted under the CTR
  • Develop excellent working relationships with NREC members and Chairpersons
  • Attend NREC meetings and record accurate minutes of proceedings and decisions, and conveying NREC decisions and other feedback
  • Maintain a working proficiency with the Clinical Trial Information System (CTIS)
  • Work closely with the other Programme Officers and Project Officers to manage and track clinical trial applications submitted through the EU portal – Clinical Trial Information System (CTIS), completing ‘CTIS’ tasks and subtasks daily within legislative timelines
  • Support the administration and management of substantial modifications applications submitted to the National Office, including applications for studies that are transitioning to the CTR
  • Assist with managing Expressions of Interest for NREC membership
  • Implement processes to track applications from submission to post-approval to ensure both legal and best-practice requirements are met in relation to research ethics, including safety and annual reporting.

Development of procedures, policies and ethics guidance

The Project Officer roles will support developing and refining processes, policies and standard operating procedures (SOPs) to ensure that the National Office adopts best-practice in all elements of its activities, both applicant- and NREC-interfacing; the Project Officer roles will have particular responsibilities for the following actions / activities:

  • Develop, refine and implement standardised internal procedures for management of NREC-CT applications where required
  • Work closely with the National Office Finance Officer to accurately monitor NREC application fees to ensure seamless application processing
  • Contribute to development and implementation of National Office policies as required
  • Develop an expertise on the ethical matters as it relates to regulated health research and the role of the NRECs
  • Contribute to and conduct literature- and legislative-based searches as required to inform the processes and procedures of the National Office
  • Actively contribute to Clinical Trial team meetings as a forum for informed solutions to pertinent issues in applications and processes
  • Develop a working knowledge of the Clinical Trials Regulations, Health Research Regulations and other applicable legislative frameworks, including the Biotech Act including keeping abreast of EU and international developments as they pertain to the work of the National Office and NREC-CTs

Stakeholder engagement and communication

The Project Officer roles will contribute to effective engagement and communication with key stakeholders including the health research community, European collaborators, Department of Health and HPRA to ensure the roles of the National Office and the NRECS are understood and that the associated processes are robust and transparent; the Project Officer roles will have particular responsibilities for the following actions / activities:

  • Be a central contact point and helpdesk function for applicant queries
  • Maintain accurate and timely content on the National Office website
  • Provide information and data on the collective of National Office activities for key stakeholders as requested, including by the Department of Health
  • Present at external meetings to foster understanding and visibility of the roles of the National Office and the NRECs
  • Liaise with other bodies involved in the regulation of health research as required including the Health Research Consent Declaration Committee (HRCDC), the HPRA, European and National clinical trial-related working groups
  • Organise webinars and other information events to support the work of the National Office including education and outreach.

Other duties may be assigned depending on need. This is a team-based role, and teamwork and coordination with others are crucial elements of the job description. 

 

Essential knowledge and experience

Formal requirements include:

At a minimum, have a NFQ Level 8 Qualification (Honours Bachelor’s degree) in a relevant field with a minimum of five years’ relevant experience. NOTE: A relevant field would be considered to be in biomedical sciences, the healthcare professions, law, and ethics.

A NFQ level 10 (Doctorate) is desirable.

Desirable criteria

The Project Officer will interact closely with the academic and healthcare research community and should therefore have a strong interest in and excellent working knowledge of these environments.

The ideal candidate will have:

  • Experience in ethics administration, ethics committee management or similar health research administration environment as a distinct advantage
  • A high degree of computer literacy, including knowledge and experience of using Microsoft Word, Excel, Outlook.
  • Experience of the Clinical Trials Information System (CTIS), databases and on-line application systems would be a distinct advantage
  • 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.

 

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. The complete list of core competencies for this post is in Appendix A and at Higher Executive Officer Competency Framework

Key competencies include the following:

  • Excellent planning and organising abilities with a strong attention to detail
  • Be result-oriented and possess excellent organisational/administrative skills
  • A demonstrable ability to multitask, prioritise, meet deadlines and manage competing and changing priorities
  • Have excellent collaboration skills with an ability to work well in a team and on own initiative
  • Strong problem analysis and resolution skills
  • Excellent communication and interpersonal skills
  • A high degree of motivation and professional integrity
  • An ability to exercise confidentiality and discretion

 

 

Reporting relationship

The Project Officer will report to a Programme Manager, National Office for NREC’s

 

Salary scale

Salary Range for Programme Manager, NREC-CT (Grade VI)                                           € 57,898 – € 70,734

This is a permanent, Full-time post

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 12.00 Noon on 25 May 2026

NOTE: Interviews for this position are expected to take place in our offices on 10 June 2026.

If you require further information, please contact Karen O’Donnell, HR Officer at recruitment@hrb.ie or refer to the recruitment page on the HRB website at http://www.hrb.ie/about/recruitment/  for full details on this campaign.

 

The HRB reserves the right to form a panel from this interview process which may remain in place for a maximum period of 12 months from the date of interview and may be used to fill posts at the same grade that arise applicable to this recruitment campaign based on order of merit. Placement on a panel is not a guarantee of appointment to a position.

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.

Please Note:

To be eligible to apply for this competition, candidates must be nationals of a European Economic Area (EEA) Member State or otherwise have a current and valid legal entitlement to work in Ireland.

Candidates who do not meet this requirement will be deemed ineligible.