- Apply by date - February 26th @ 5pm
Title: Clinical Research Quality & Regulatory Affairs Manager
Department: RCSI Clinical Research Centre(s)
Tenure: 39 hours per week, permanent position, flexible hybrid work options
Location: Across RCSI Hospital Group sites, including Beaumont Hospital and Rotunda Hospital
Reporting to: Mark Sherlock (RCSI CRC Director)
Salary: €60,000 per annum
Start Date: March 2023
About the role:
RCSI now wish to appoint a high calibre individual to the role of Clinical Research Quality and Regulatory Affairs Manager (QRAM) at the RCSI Clinical Research Centre (CRC), Beaumont Hospital. The QRAM will lead the CRC team in the management and execution of the Quality Management System (QMS) for the conduct of world class clinical research at the CRC. This exciting role, is a permanent post with RCSI offering flexible, hybrid working arrangements
Specific Duties:
- Plan, manage and execute the Quality Management System (QMS) for the conduct of Clinical research at the RCSI Clinical Research Centres (CRCs). This includes the development / update of the CRCs Quality Management systems manual, development / update and management of RCSI CRCs 2 standard operating procedures (SOPs), development and update of quality document templates and other relevant documents
- Provide support to Principal Investigators (PIs) in developing and implementing and monitoring clinical trial- specific quality systems. This includes but it is not limited to ensuring that SOPs are created, reviewed, revised, approved and retired according to the SOP review schedule for Clinical Trials activities
- Support with internal approvals of industry sponsored studies
- Deliver Good Clinical Practice (GCP) compliance oversight and guidance to clinical teams at RCSI CRC(s)
- Manage Corrective and Preventative Action Plans (CAPAs) and other quality issues arising with the QMS or with clinical studies conducted at the RCSI CRCs
- Assist the RCSI CRCs and the RCSI Sponsor Office in the orientation and training of clinical site staff on GCP and applicable SOPs.
- Manage the RCSI CRCs training matrix as applicable.
- Assist the RCSI Sponsor Office with the identification of potential compliance risks and propose quality improvement strategies for Clinical Trials and related activities at the RCSI CRCs.
- Assist the RCSI Sponsor Office in the review of key documents including but not limited to; study protocols, PILs and other study documents.
- Provide support to the RCSI Sponsor Office and the CRCs in managing internal and external audits as well as Regulatory Inspections for Clinical Trials and related activities.
- Participate in quality working groups nationally and update CRC staff on relevant issues.
- Attend routine RCSI CRCs meetings.
- Carry out any other quality related tasks that arise within the CRC as directed by the CRC Director or the RCSI Sponsor Office.
Qualifications:
Third level qualification (or equivalent e.g. nursing qualification) in a clinical or life sciences related subject
Essential Candidate Requirements:
- Significant recent experience in a clinical research setting with a strong understanding of the requirements of Clinical Research Quality Management Systems.
- Excellent knowledge of the ICH GCP Guidelines
- Willingness and flexibility to travel between clinical sites
Application Process
Submit an application online through our RCSI careers portal. Informal Enquiries can be directed to Ailbhe Cullen (acullen@rcsi.com).
Job Description: JD Quality Manager CRC