Senior Research Co-Ordinator - Director of Quality and Regulatory Affairs Clinical Research Facility UCC
Specific Purpose Whole Time Post
(Anticipated Duration 16 Months)
This is an opportunity for an experienced Clinical research professional who has experience in Quality, Pharmacovigilance and Regulatory Affairs to undertake the role of Quality, PV and Regulatory Affairs Director of clinical research at University College Cork.
The post holder will play a key role in assuring that University College Cork meets its regulatory obligations as a Sponsor of Regulated Clinical trials (investigational medicinal products) and Clinical Investigations (Devices), as well maintaining and improving Quality, Regulatory and Pharmacovigilance processes and systems of the HRB-CRF-C to assure the quality of clinical research at UCC, in accordance with the International Council on Harmonisation Good Clinical Practice Guidelines (ICH-GCP), the Clinical Trials Directive/Regulation, medical device regulations and all other relevant standards and regulations.
The post holder will carry out risk-based sponsor audits on UCC sponsored studies (regulated and non-regulated), oversee the submission of clinical trial applications (IMP and Devices) to relevant competent authorities and oversee pharmacovigilance activities including timely submission of SUSARs (Suspected Unexpected Serious Adverse Reactions) and Development Safety Update Reports (DSURs) to the competent authorities.
The post holder will supervise Quality Assurance (QA) and Quality Control (QC) initiatives to ensure that UCC meets the highest standards. The post holder will coordinate preparation of UCC clinical research activity and its investigators sites for external audit and regulatory inspection by the Health Products Regulatory Authority or other regulatory authorities.
The post holder is responsible for interpreting complex legislation relating to clinical research, identifying the implications for UCC as a sponsor and taking appropriate action to ensure continued compliance.
The post holder will work closely with the UCC Sponsor Officer (CRRO) and the HRB-CRF-UCC Quality staff.
Project Title: CRF UCC
Post Duration: 16 Months
Salary: €90,754 p.a. 1 FTE
For an information package including further details of the post see https://ore.ucc.ie/
Informal enquiries can be made in confidence to Dr Muiris Dowling, Clinical Research Reporting Officer Email Address: maurice.dowling@ucc.ie
Application Instructions
Applications must be submitted online via the University College Cork vacancy portal (https://ore.ucc.ie/). 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 8th August 2025
No late applications will be accepted.
Please note that an appointment to posts advertised will be dependent on University approval, together with the terms of the employment control framework for the higher education sector.
UCC is committed to creating and fully embracing an inclusive environment where diversity is celebrated. As a University we strive to create a workplace that reflects the diversity of our student population where people from a wide variety of backgrounds learn from one another, share ideas, and work collaboratively. UCC is committed to being an employer that recognises the value of diversity amongst its staff. We encourage applicants to consult our policies at https://www.ucc.ie/en/edi/policies/ and initiatives at https://www.ucc.ie/en/edi/implementation/ and we welcome applications from everyone, including those who are underrepresented in the protected characteristics set out in our Equal Opportunities & Diversity Policy.
UNIVERSITY COLLEGE CORK IS AN EQUAL OPPORTUNITIES EMPLOYER