Project Officer (Health)

Overview

This is an 11-month contract opportunity for a Project Officer in the health and research governance space. The role supports clinical trial ethics review operations, policy and process development, and engagement with a wide range of stakeholders. It is based in Dublin, County Dublin, Ireland.

Clinical Trial and Ethics Review Operations

• Offer guidance to prospective applicants and sponsors, and handle their queries.
• Coordinate ethics review applications from initial submission through final determination and post-approval oversight.
• Drive ongoing improvements to application handling, review procedures, and supporting documents such as forms, checklists, guidance notes, and FAQs.
• Arrange ethics committee meetings, including member coordination, agenda preparation, circulation of meeting packs, and response management.
• Support the assembly and review of ethics application dossiers.
• Build practical knowledge of Clinical Trial Regulation requirements, including Part I and Part II dossier review steps and related timelines.
• Work with ethics committee members to shape and complete ethics opinions for clinical trial submissions and substantial modifications.
• Attend committee meetings, take accurate minutes, and communicate outcomes and feedback to applicants.
• Maintain effective use of the Clinical Trial Information System (CTIS).
• Track clinical trial submissions in CTIS and ensure all actions and deadlines stay within statutory timelines.
• Assist with administration of substantial modification applications and studies moving under the Clinical Trials Regulation framework.
• Support committee membership recruitment and management of expressions of interest.
• Create and sustain tracking systems for applications, post-approval follow-up, safety reporting, and annual reporting obligations.

Process Development, Policy and Guidance

• Draft, update, and implement standard operating procedures and internal workflows to improve application management.
• Work with finance colleagues to monitor application fees and associated administrative processes accurately.
• Contribute to organisational policy work and governance frameworks.
• Develop subject-matter understanding of ethical issues in regulated health research and clinical trials.
• Carry out literature and legislative research to support policy, operations, and best-practice guidance.
• Contribute actively in team discussions by suggesting solutions to operational, regulatory, and ethical matters.
• Maintain a strong grasp of the Clinical Trials Regulation, Health Research Regulations, biotechnology legislation, and other applicable Irish and European frameworks.
• Track new European and international developments relevant to clinical research ethics and governance.

Stakeholder Engagement and Communications

• Serve as a primary contact for applicant and stakeholder enquiries.
• Keep website content and guidance materials current and accurate.
• Prepare reports, data summaries, and activity updates for stakeholders and governance bodies.
• Represent the organisation at external meetings, conferences, webinars, and information sessions to support understanding of research ethics and clinical trial governance.
• Engage with regulators, government departments, research organisations, and national and international working groups involved in health research oversight.
• Plan educational events, webinars, and outreach activities to build awareness of research ethics and clinical trial processes.

Formal Requirements

The role calls for either a PhD, or at minimum a qualification at NFQ Level 9 such as a Master's degree or Postgraduate Diploma in a relevant discipline, together with at least 3 years of relevant post-degree experience. Alternatively, candidates with at least an NFQ Level 8 Honours Bachelor's degree in a relevant field need at least 5 years of relevant experience.

Relevant disciplines include biomedical sciences, pharmacy, the healthcare professions, law, and ethics.

Ideal Background

Experience in ethics administration, ethics committee management, or a similar health research administration environment would be a strong advantage. The successful candidate should also be highly computer literate, with strong working knowledge of Microsoft Word, Excel, and Outlook. Experience with CTIS, databases, and online application systems would be beneficial. A solid understanding of clinical trials research, research methodology, scientific principles, health research ethics and governance, and national and European health research legislation and regulations, including the CTR, is expected.

Additional Information

This position is being recruited on behalf of a client. No stipend or salary amount was specified in the source information.