Vacancies

Quality and Regulatory Affairs Manager

Post status: Specific Purpose Contract

Hours of Post: Full-time

Salary: This appointment will be made on the Administrative Officer 1 Salary Scale to the bar (€60,692 – €78,512 per annum) at a point in line with the current Government pay policy.

Closing date:31-May-2022 12:00 noon

The Quality and Regulatory Affairs Manager will be based in the Wellcome-HRB Clinical Research Facility (CRF) at St James’s Hospital (CRF) and will be responsible for developing and contributing to the quality management system of the CRF and ensuring the highest standards are applied to studies taking place including studies and CTs sponsored by Trinity College Dublin. The QRAM will work as part of the broader CRF quality team which includes a senior QRAM, a quality data manager and study monitor and Quality Officer.  In addition to implementation of the quality and regulatory affairs system and ensuring inspection readiness the successful postholder will also be responsible for providing clinical and regulatory advice relevant to study approval, protocol development, start-up, progress and risk-based monitoring to potential principal investigators from both the Hospital and the University. They will share the workload of pharmacovigilance and monitoring with the rest of the quality team. The QRAM will maintain systems to assure the quality of clinical research undertaken within the CRF, in accordance with the International Conference on Harmonisation Good Clinical Practice Guidelines (ICH-GCP), National and European legislation and any relevant quality standards.  The CRF supports a broad range of clinical research studies including advanced therapy and investigational medicinal products (medical devices, biobanking and observational research.  The QRAM will support regulatory compliance of the CRF and associated research projects and will assist investigators with application submissions to research ethics committees, competent authorities and HRCDC.

 

How to apply:

Listings of all current vacancies can be viewed and applied for via our online job application system at https://jobs.tcd.ie.

Each applicant will be required to register with the system. The job application process is short & simple and you will be required to complete a short online application form and attach your CV, Cover Letter and other supporting documentation where appropriate.

Trinity is an equal opportunities employer and is committed to employment policies, procedures and practices which do not discriminate on grounds such as gender, civil status, family status, age, disability, race, religious belief, sexual orientation or membership of the travelling community. On that basis, we encourage and welcome talented people from all backgrounds to join our staff community. Trinity’s Diversity Statement can be viewed in full at https://www.tcd.ie/diversity-inclusion/diversity-statement.

In order to assist the selection process, applicants should submit a Curriculum Vitae, a Cover Letter (1x A4 page) that specifically address the following points in their application and contact details of 3 referees (including email addresses).

  • Applicants should clearly address their experience and how they obtained their knowledge in their application.
  • Illustrate, through past examples, their ability to work on their own initiative and resolve problems.

Applicants who do not address the application requirements above in their cover letter will not be considered at the shortlist stage. Applications must be submitted by the closing date specified through eRecruitment. Any Applications which are still in progress at the closing time on the specified closing date will be cancelled automatically by the system.

For informal enquiries, please contact Professor Martina Hennessy at mhenness@tcd.ie

Application queries about this post, please email Clodagh Daly at dalyc28@tcd.ie and include the Competition ID number in the subject heading.

Download the Job Ad at the following link: QRAM Job Ad 
Download the Application information document at the following link:  Application Information