Quality Manager CRC – RCSI
Department: RCSI Clinical Research Centres
Tenure: 39 hours per week, permanent position
Location: RCSI Hospital Group sites, incl. Beaumont and Rotunda Hospital
Reporting to: Mark Sherlock (RCSI CRC Director)
Salary: €60,000 per annum
Proposed Start Date: January 2023
RCSI is a community of academic, research and professional staff working collaboratively to lead the world to better health. Here, you will thrive in an innovative and inclusive atmosphere and your personal development and wellbeing will be supported. We invite you to join us to help deliver on our exciting mission “To educate, nurture and discover for the benefit of human health”. We seek candidates whose experience to date has prepared them to contribute to our commitment to the “Race Equality Action Plan 2021-2024” at RCSI.
About Our Research
RCSI recognises that excellence in research is critical to the quality of its educational activities, its credibility, and, overall, to its mission to enhance human health. RCSI’s research strategy aims to build upon its strength in translational biomedical and clinical research to deliver transformational, high impact changes in health care. Targeting both Irish national and EU funding, along with increased collaboration with industry, is a major part of the RCSI research strategy. Forging increased collaboration between RCSI PIs and industry is of critical importance to achieving success in this area. RCSI is also committed to provide its researchers with the supports and developmental opportunities to enable them to continuously grow and support their overall career development.
Specific Duties:
- 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)
- 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 standard operating procedures (SOPs), development and update of quality document templates and other relevant documents.
- 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
- 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
- Attend routine RCSI CRCs
- 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 g. nursing qualification) in a clinical or life sciences related subject.
Essential Candidate Requirements:
- Significant recent experience in a clinical research setting
- Excellent knowledge of the ICH GCP Guidelines
- Willingness and flexibility to travel between clinical sites
- Excellent IT skills including Microsoft Office (particularly Word, Excel and PowerPoint) and internet and email systems
- Ability to work independently and with drive to make the clinical research team efficient and effective
- Experience in training of site staff
- Strong leadership with demonstrated ability to collaborate with senior leaders
- Good problem solving, written and verbal communication skills
- Ability to effectively manage multiple priorities with a sense of urgency
- Attention to detail and accuracy of work
Desirable Knowledge & Experience:
- Relevant experience in any of the following areas: quality management, project management, drug safety, auditing, clinical research associate or as a clinical research nurse
- Previous experience working in the field of commercial/non-commercial/academic research is an advantage
- Knowledge of HPRA clinical trial and safety regulations and ICH GCP Guidelines
- Previous experience of clinical research document development and contribution to protocol development
- Experience of standard operating procedure development or organisational policy development
We are all too aware that imposter syndrome and the confidence gap can sometimes stop fantastic candidates putting themselves forward, so please do submit an application — we’d love to hear from you.
Application Process
Submit an application online through our RCSI careers portal. Informal Enquiries can be directed to Ailbhe Cullen (acullen@rcsi.com).
Click here to read our Recruitment and Selection Policy for Researcher.
Employee Benefits
RCSI make sure you have the resources you need to thrive by offering a wide range of benefits in areas including time away, finance, community, health, and well-being and insuring your financial future. Below are some additional benefits available to you as an RCSI employee:
- Minimum of 20 days annual leave, plus an additional 5 Privilege days
- Flexible/hybrid working options for colleagues across many roles
- Additional leave options paid maternity leave, paternity/parental leave, study leave
- 7% Employer pension contribution
- Onsite gym €10 per/mth classes and PT sessions
- Childcare support 20% discount at Giraffe
- Free eye test and annual flu vaccination
- TaxSaver commuter tickets and Bike to Work schemes
- A site sustainability team focusing on the environmental initiatives; Green Campus Initiative ’
- Competitively priced café and restaurant
- Equality, Diversity & Inclusion forums, and network groups
- Employee assistance programme with Spectrum Life
- Learning and Development training programmes LinkedIn Learning for career progression
- Discounted services GP visits, 10% off dental, staff parking, mobile tariffs, Group Scheme discount on numerous brands
- Sports and social club yoga, Pilates, fitness classes, Zumba, running club, social evenings, Summer BBQ
- Ticket Draws for events including; Rugby, Taste of Dublin, Dublin Horse Show, theatre, music & comedy events
About The Royal College of Surgeons
RCSI is a unique institution. Founded in 1784 as the national provider of surgical training in Ireland, we have evolved in the years since to become one of the world’s leading health sciences universities, with a global reach and operations in Ireland, the Middle East, and Southeast Asia. Our students learn in a truly immersive environment where teaching, research, public policy, and outreach activities focus singularly on building multi-disciplinary excellence in healthcare.
For each of the last six years, RCSI has been positioned in the Top 250 of universities worldwide and ranked in the world’s Top 50 by Times Higher Education for our contribution to the United Nations’ Sustainable Development Goal Number 3 ‘Good Health and Well-being’. This reflects our commitment to supporting people of all ages to live healthy lives and our work to promote the concepts of well-being and positive health.
Note: This job description may be subject to change to reflect the evolving requirements of the Department and RCSI. Similar vacancies that arise in the next 6 months may be filled from the pool of applicants that apply for this position. RCSI is proud to be an equal opportunity employer and welcome applications from all suitably qualified persons regardless of their gender, civil status, family status, sexual orientation, religion, age, disability or race. RCSI is committed to embedding equality, diversity and inclusion (EDI) across everything we do. This ensures we can all work and learn in an environment defined by dignity and respect. Eligibility to work in Ireland is a requirement of this role, Proof of eligibility documentation will be required at a later date. Under limited and specific circumstances (research/ specialist roles) RCSI may be in a position to seek a hosting agreement and/or work permits. Employees are required to undertake 6 months service in their current role before applying for other internal opportunities, unless agreed in advance by the SMT representative
Closing Date
27-Jan-2023
