Senior Research Co-Ordinator - Quality Officer

Organisation/Company University College Cork Department HR Research Research Field Medical sciences " Other Researcher Profile Leading Researcher (R4) Positions Other Positions Country Ireland Application Deadline 8 Sep 2025 - 12:00 (Europe/Dublin) Type of Contract Temporary Job Status Full-time Is the job funded through the EU Research Framework Programme? Not funded by a EU programme Is the Job related to staff position within a Research Infrastructure? No

INFANT is now accepting applications for a Senior Research Coordinator - Quality Officer. The Quality Officer will work with the INFANT Quality and Regulatory Manager, PIs, clinical staff, study teams, in4kids Clinical Trials Network, sponsors, and other stakeholders, on quality and regulatory affairs issues pertaining to maternal and child health research studies.

INFANT leads the HRB Irish Network for Children's Clinical Trials (in4kids) that supports researchers in Ireland to deliver high-quality clinical trials to improve children's health.

The Quality Officer will be responsible for all research projects monitoring visits and generation of detailed reports ensuring a high standard of quality across all studies at INFANT and across the in4kids clinical trials network. They will provide quality control applications both regulated and observational studies to Research Ethics Committees and Regulatory Authorities. They will chair and conduct clinical trial meetings monthly and liaise with PIs and project managers on study related issues and ethics committees and regulatory authority queries. The Quality Officer will be involved in the training of all INFANT personnel in Good Clinical Practice and in new staff induction and maintenance of relevant personnel training records. As a member of the Operations Team, the Quality Officer will report on personnel training and designated training activities implemented within the Centre.

The Quality Officer will also assist the QRAM in maintaining and updating INFANT QMS as required.

The Senior Research Coordinator - Quality Officer will work closely with the Quality & Regulatory Manager and the wider operational team to ensure all operational, administrative, and compliance functions within INFANT are being properly executed in accordance to best practices. This will include the following duties:

• Manage own workload, liaising with INFANT Quality & Regulatory Manager to ensure all projects have been quality controlled and any queries followed up and resolved.
• Coordinate and chair monthly clinical study meetings with all relevant personnel and maintain a tracker of the studies and any updates
• Ensure safety reporting for all studies is performed and the appropriate documentation is completed and events reported to Principal Investigator, Ethics Committee and relevant authorities if required.
• Participate in Health & Safety Audit and corrective action implementation as indicated in the Audit Report. Member of INFANT H&S Team
• Participate in teaching programmes and training for INFANT personnel especially any updates to Good Clinical Practice Guideline.
• Assist/educate new personnel in generation of research protocols and any study related documentation as required
• Complete and attend any relevant courses that will enhance knowledge and maintain current best practices in research
• Generate new Standard Operating Procedures if required encompassing INFANT ISO Accredited QMS.
• Assist INFANT QRAM in completing internal audit of QMS and generation of audit findings and corrective actions
• Have oversight of INFANT QMS and all relevant documentation and processes.
• Awareness of any Opportunities for Improvement and implementation of appropriate documentation as required.
• Constant horizon scanning ensuring INFANT policies and procedures are current and best practice
• Liaise and interact with UCC Clinical Research Reporting Officer (CRRO) and UCC Data Protection Officer (DPO) for all UCC sponsored clinical research as required

Quality: Trial Monitoring

• Develop monitoring plans in collaboration with QRAM, and project managers.
• Conduct onsite and remote monitoring for a variety of clinical trials including clinical trials of Investigational Medicinal Products (CTIMP), clinical investigations of medical devices, other interventional trials and observational studies in Ireland and Europe.
• Monitor sites / studies to ensure compliance with the protocol, standard operating procedures, ICH-Good Clinical Practice and relevant EU and Irish legislation. Conduct Source document verification (SDV), verify validity of Patient Informed Consent Forms, and review Investigator Site File and drug / device accountability records at study sites.
• Prepare comprehensive monitoring reports and follow up letters to study sites.
• Capture protocol violations and implement CAPAs, provide relevant training to site personnel.
• Management of IMP at the centre involving liaising with research pharmacists and maintaining all documentation from IMP receipt to destruction as required
• Liaise with the QRAM, PIs, Study Teams, Clinical Staff, in4kids Network, Sponsors and other stakeholders on quality and regulatory affairs issues.

Regulatory Affairs

• Quality control (QC) initial applications and amendments to Research Ethics Committees (REC) in Ireland and in EU (If applicable) for Clinical trials, and clinical investigations.
• Quality control clinical trial and clinical investigation applications and amendments to regulatory authorities (RA) including HPRA (Ireland), MHRA (UK) and other regulatory authorities in Europe as required.
• Liaise with relevant Project Manager (PM) on REC & RA queries and responses if required.
• QC of annual updates/progress reports to REC and RAs as required.
• QC end of trial notifications to REC and RAs.
• Access and familiarisation with CTIS system and completion of CTIS applications and study amendments as required.

• A PhD or postgraduate qualification in a relevant field or discipline.
• At least 5+ years' experience in Clinical Quality involving both observational and regulated research
• Knowledge and understanding of ICH-GCP R3 and the relevant Irish and EU legislation governing Clinical Trials and Clinical Investigations - CTR and MDR.
• Excellent report writing and presentation skills
• Demonstrable knowledge of good clinical practice ICH GCP E6 R3.
• Access to CTIS and ability to navigate the portal
• Working knowledge of clinical research electronic data capture systems
• Excellent communication and interpersonal skills in order to communicate effectively with staff, students and stakeholders.
• Ability to develop good working relationships.
• Experience of working in a multidisciplinary research team environment and working with people from a wide range of cultures.
• Capacity to manage and prioritise a high workload, with a track record of delivering results under pressure and on time.
• Working knowledge of ISO 9001:2015 and relevant documentation
• Evidence of ongoing professional development