The European Clinical Research Infrastructure Network (ECRIN, www.ecrin.org), a public research organisation, is currently recruiting a Quality Officer, to be based at its Paris head office.
ECRIN is a not-for-profit, distributed infrastructure. It was awarded the legal status of a European Research Infrastructure Consortium (ERIC) in 2013 based on Council Regulation (EC) N° 723/2009 of 25th June 2009 on the Community legal framework for an ERIC.
ECRIN provides support to the management of multinational clinical research projects in Europe focused on Sponsor’s tasks and responsibilities. ECRIN is based on the connection of national networks of clinical research infrastructures, mainly clinical trial units, having the capacity to manage clinical studies nationally. ECRIN provides information, consultations and services to Sponsors and/or investigators of investigator initiated clinical studies. ECRIN’s involvement covers all activities, from study planning and preparation of grant application, to the set-up and conduct of multinational clinical studies in any disease area. Most of the ECRIN-supported projects are funded by the Horizon 2020 (H2020) Programme of the European Union or by the Innovative Medicines Initiative (IMI).
ECRIN also coordinates or participates in infrastructure development projects (in particular on clinical trial data), in various partnerships, international cooperation and strategic initiatives.
The Quality Officer main mission is to assist the Head of Quality and IS in the preparation of ECRIN ISO 9001:2015 certification.
The main duties of the ECRIN Quality Officer will include the following:
Quality Documentation System
Contribute to prepare ECRIN ISO 9001:2015 certification in conjunction with QA management
To participate to the development of ECRIN quality documents.
To maintain and update the ECRIN quality documents.
Quality internal audits
To assist quality management with internal audit scheduling, and preparation.
To contribute to the internal audit performance and reporting.
Piloting quality and improvements
To assist quality management in the follow-up of risks, deviations, and CAPA.
Filling and archiving
To contribute to maintain, improve ECRIN information, documents filling and archiving.
University degree in quality and/or university degree in science, biology A first professional experience on a similar quality function would be an added value.
Experience of auditing in a research environment
Experience of risk and deviation assessment
Proactive, organized and autonomous, you enjoy team working, and are able to produce accurate work within deadlines,
Excellent written and spoken English (working language)
Good verbal, written and interpersonal skills.
The post is under the responsibility of the Head of quality and information systems. The Quality Officer shall work in close collaboration with the ECRIN Management Office in Paris and the national European Correspondents based in the ECRIN member/observer countries.
The post is short term (6 months to 12 months) and can be full-time or part time contract according to French law. The salary is set according to European/international standards for similar positions, and will depend on qualifications and experience.
Place of employment: Paris, France, where ECRIN has its Management Office and legal address.
A letter of motivation with a Curriculum Vitae (European format with photo) may be addressed to Mrs Alicja Szofer-Araya (email@example.com).
Deadline to receive applications: March 6th, 2020
Expected start date as soon as possible, end of March 2020
ECRIN is an inclusive, equal opportunity and non-discrimination employer offering attractive conditions and benefits appropriate to an international research organisation.