Project Officer

Eden Recruitment; Dublin; On-site; EUR 60,000 - 80,000; Full time

Job summary

Eden Recruitment, on behalf of our client in Ireland, is seeking a Project Officer on a 9-month contract to support ethics review operations and regulatory compliance.

You will guide applicants and sponsors, prepare ethics dossiers, coordinate ethics committee meetings, maintain CTIS, and help develop SOPs across CTR and Health Research regulations.

Qualifications

• Ideally PhD, but NFQ Level 9 with 3+ years post-degree experience.
• Alternatively NFQ Level 8 with 5+ years relevant experience.

Responsibilities

• Provide guidance and respond to queries from applicants and sponsors.
• Manage ethics review applications from submission through final decision and post-approval monitoring.
• Organise ethics committee meetings: liaise with members, prepare materials, and respond to queries.
• Coordinate preparation and review of ethics dossiers and CTIS submissions.
• Develop and maintain SOPs and governance frameworks for ethics processes.

Skills

Ethics administration

Regulatory knowledge

Microsoft Word/Excel/Outlook

CTIS proficiency

Policy development

Education

NFQ Level 9 qualification (Masters / Post Graduate Diploma)

NFQ Level 8 qualification (Honours Bachelor’s)

Tools

CTIS

Databases

Online application systems

Job description

On behalf of our client, we are hiring a Project Officer on a 9 month contract.

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.

Key Responsibilities:

Clinical Trial and Ethics Review Operations

• Provide guidance and respond to queries from prospective applicants and sponsors.
• Support the management of ethics review applications from submission through to final decision and post-approval monitoring.
• Champion continuous improvement initiatives to enhance application processes, review workflows, and supporting documentation, including application forms, checklists, guidance documents, and FAQs.
• Organise ethics committee meetings, including member liaison, agenda planning, preparation and distribution of meeting materials, and responding to member queries.
• Coordinate the preparation and review of ethics application dossiers.
• Develop a strong working knowledge of Clinical Trial Regulation (CTR) requirements, including Part I and Part II dossier assessment processes and associated timelines.
• Work collaboratively with ethics committee members to support the development and finalisation of ethics opinions for clinical trial applications and substantial modifications.
• Attend committee meetings, record accurate minutes, and communicate decisions and feedback to applicants.
• Maintain proficiency in the Clinical Trial Information System (CTIS).
• Monitor and track clinical trial applications submitted through CTIS, ensuring all tasks and deadlines are managed within legislative timelines.
• Support the administration and management of substantial modification applications and studies transitioning under the Clinical Trials Regulation.
• Assist in the management of committee membership recruitment and expressions of interest.
• Implement and maintain systems to track applications from submission through post-approval activities, including safety reporting and annual reporting requirements.

Process Development, Policy and Guidance

• Develop, refine and implement standard operating procedures (SOPs) and internal processes to support efficient application management.
• Work closely with finance colleagues to support accurate monitoring of application fees and related administrative processes.
• Contribute to the development and implementation of organisational policies and governance frameworks.
• Build expertise in ethical issues relating to regulated health research and clinical trials.
• Conduct literature reviews and legislative research to inform policy development, operational processes, and best practice guidance.
• Actively participate in team meetings, contributing solutions to operational, regulatory, and ethical issues.
• Develop and maintain a strong understanding of the Clinical Trials Regulation, Health Research Regulations, biotechnology legislation, and other relevant national and European regulatory frameworks.
• Monitor emerging European and international developments relevant to clinical research ethics and governance.

Stakeholder Engagement and Communications

• Act as a central point of contact for applicant and stakeholder enquiries.
• Maintain accurate and up-to-date website content and guidance materials.
• Prepare reports, data summaries, and activity updates for key stakeholders and governance bodies.
• Present at external meetings, conferences, webinars, and information sessions to promote understanding of research ethics processes and clinical trial governance.
• Liaise with regulatory authorities, government departments, research organisations, and national and international working groups involved in health research oversight.
• Organise educational events, webinars, and outreach initiatives to support awareness and understanding of research ethics and clinical trial processes.

Formal requirements include:

Ideally, the successful candidates will be PhD qualified but must, at a minimum, have a NFQ Level 9 qualification (Masters / Post Graduate Diploma) in a relevant field with a minimum of three years’ relevant experience post-degree,orAt a minimum, have a NFQ Level 8 Qualification (Honours Bachelor’s degree) in a relevant field with a minimum of five years’ relevant

experience

The ideal candidate

• 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.