Quality and Regulatory Affairs Manager
University of Dublin, Trinity College -School of Medicine, Faculty of Health Sciences
Post Status: Fixed term contract until 31st December 2017
Location: HRB Clinical Research Facility (CRF) at St. James’s Hospital, Dublin 2
Reports to: Associate Director
Closing Date: Noon, Friday, 17th May 2013
Salary Range: Funding for this post is provided by the Health Research Board, therefore this appointment will be made on the Administrative Officer 3 (Trinity College Dublin) salary scale at a point in line with current Government pay policy.
The post holder will develop, implement and maintain systems to assure the quality of clinical research undertaken within the Clinical Research Facility (CRF), in accordance with the International Conference on Harmonisation Good Clinical Practice Guidelines (ICH-GCP), the Clinical Trials Directive and any relevant quality standards. The post holder will also coordinate and submit clinical trial submissions to relevant competent authorities.
The post holder will also lead on Quality Assurance (QA) initiatives to ensure that the CRF meets its required standards. The post holder will coordinate CRF preparation for external audit and regulatory inspection by Irish Medicines Board.
The post holder will maintain systems to ensure that clinical trials carried out within the CRF are conducted in accordance with ICH GCP guidelines, local legislation and the Clinical Trials Directive, establish and maintain a quality system that supports the activities of the CRF and implement and monitor systems to ensure regulatory compliance throughout the lifecycle of CRF studies, developing QA procedures to support study initiation, study implementation, study close down and study archiving.
The ideal candidate will have a Bachelor’s degree, clinical research experience and experience in projects/study management and good clinical practice training.
The start date will be as soon as possible.
Visit www.tcd.ie/vacancies by clicking on the Apply button below for full job specification and details of how to apply online.
Applications will only be accepted by e-Recruitment.
Trinity College Dublin is an equal opportunities employer.
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