Position Summary
APC Microbiome Ireland Taighde Éireann – Research Ireland Centre, founded as the Alimentary Pharmabotic Centre in 2003, is about people working together across the boundaries of traditional research sectors. Over the last 20 years, APC Microbiome Ireland has established itself as one of the leading global centres in gut microbiota and gut inflammation research. The scientific organisation of the research centre consists of several integrated research themes in microbiome science, which are supported by multiple shared technology platforms, including a Human Studies Platform. It represents a seamless collaboration between researchers at University College Cork, Teagasc Moorepark, MTU, and clinicians at our teaching hospitals, with over 300 contributors, including Principal Investigators, clinicians, management and operations staff, research scientists, assistants, and postgraduate students.
It is widely recognised that the gut microbiota plays an important role in human health and has become one of the most dynamic, complex, and exciting areas of research. APC Microbiome Ireland's Human Studies platform (HSP) is at the forefront of this cutting-edge research, facilitating high-quality human studies that explore the impact of the gut microbiome on health and disease. The platform supports a multidisciplinary approach, bringing together experts in microbiology, clinical science, and data analysis to deliver world-class research and innovation.
We are now recruiting a Quality Documentation Officer, who will play a pivotal role in ensuring that all Human study quality documentation and processes align with regulatory standards and best practices. Key tasks include managing and maintaining quality management systems (QMS), preparing and updating standard operating procedures (SOPs), coordinating audits and inspections, and supporting compliance with ethical and regulatory frameworks. Your attention to detail and commitment to quality will be integral to the success of APC's research initiatives.
Key Duties:
1. Maintain and further develop the HSP QMS
2. Assist APC project teams with study design
3. Review all HSP ethical submissions
4. Facilitate documentation submission to Research Ethics Committees (RECs) and Hospital review boards as required.
5. Correspond with RECs and Competent authorities with regard to submissions, queries and amendments.
6. Liaise with the UCC Sponsor Office/OVPRI/OCLA/DPO in relation to study documentation and sign-off.
7. Assist with UCC Greenlight Approvals
8. Perform internal audits
9. Liaise with external stakeholders such as industry partners in relation to the HSP
10. Attend university/national meetings in relation to Quality & Ethical issues
11. To perform duties with confidentiality, discretion, tact, and diplomacy as required.
Project Title: APC Human Studies Platform
Post Duration: 22 Months
Salary: €51,651 p.a. (Personal rate)
For an information package including further details of the post see here.
Informal enquiries can be made in confidence to Lorraine Draper, Operations Manager - APC Microbiome Ireland Tel: + 353 (0) 21 490 1753; Email: l.draper@ucc.ie
Applications must be submitted online via the University College Cork vacancy portal (here). Queries relating to the online application process should be referred to recruitment@ucc.ie, quoting the job-title and project name.
Candidates should apply, in confidence, before 12 noon (Irish Local Time) on Friday 10th January 2025.
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