The European Clinical Research Infrastructure Network (ECRIN, www.ecrin.org), is a not for profit, public research organisation, supporting clinical research across Europe. ECRIN is connecting national clinical research networks (mainly academic clinical trial units (CTUs)), having the capacity to manage clinical trials on the national level. ECRIN provides information, consultations and operational clinical trial tasks and services to Sponsors and/or investigators of clinical trials initiated by academic investigators or SMEs. ECRIN’s involvement covers all clinical trial activities, from study planning and preparation of grant application, to the set-up and conduct of multinational clinical trials in any disease area. ECRIN is also developing tools, services to facilitate multinational clinical trials and is running a data centre certification programme. ECRIN Management Office is based in Paris, France.
We are looking for a part-time Quality Assurance Auditor (GCP).
Your main mission will be the oversight and coordination of the data centre certification programme and the conduct and management of audits in the field of GCP (data centres, clinical trial units) to ensure compliance with our Quality Policy, internal procedures and standards, and regulatory requirements in force.
Data management centre certification programme
- Operate the secretariat of the programme and plan, coordinate and follow up the Certification Board decisions and actions.
- Maintain, develop and train the pool of auditors
- Maintain and develop the standards
- Maintain and develop the audit data base
- Conduct or lead audits of the data centres as appropriate
- Plan, coordinate, lead, conduct and report audits of the structures/projects
- Advise and support audited structures on the design and implementation of Corrective and Preventive Actions (CAPA) to ensure compliance with regulatory requirements and internal procedures.
- Approve the corrective and preventive actions (CAPA) related to the audits and follow-up until the closure of the audit.
- Perform the development, implementation, maintenance and improvement of the ECRIN-ERIC quality management system and the quality documents related to audit
- Maintain the ISO 9001:2015 certification for the service “data management centre certification programme”
- Participate in projects as requested
- Provide support to staff as appropriate
- Review and track quality audit KPIs
- Undertake any ad hoc initiatives as required by the Directors
- University degree in Health or Life Sciences with experience in quality or quality diploma/qualification
- Experience in multinational clinical research
- Experience in the management of quality
- Experience in leading/performing audits
- Experience in operating at European/international level and in multicultural environments
- Excellent organisational and time management skills, and ability in managing tasks across various functions and projects
- Excellent oral and written communication skills
- Team player
- Excellent written and spoken English (working language)
- Computer and software knowledge
The post is under the responsibility of the Operations Director.
You will work closely with our multicultural core team based in Paris and with our staff located in the various ECRIN countries.
The post is a 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.
The position is based in our Management Office in Paris. Possibility for partly remote working.
A letter of motivation with a Curriculum Vitae (European format with photo) shall be addressed to Mrs Alicja Szofer-Araya (email@example.com), who may also be contacted for further details.
Deadline to receive applications: 30 September 2022
Expected start date: as soon as possible
ECRIN is an inclusive, equal opportunity and non-discrimination employer offering attractive conditions and benefits appropriate to an international research organisation.
More information on ECRIN at www.ecrin.org