We are seeking a clinical start up specialist with a degree in scientific disciplines to join the Quality Assurance and Regulatory Affairs for Clinical studies Service starting from October 2025
The Regulatory Affairs Service aims to support, advise, and assist the Laboratories dealing with Clinical Studies in regulatory activities during start-up activities and throughout the course of the study.
It may also be consulted at any time during the conduct of the study in case of doubts or particularly relevant issues regarding regulatory activities.
Moreover the Service gives support for regulatory issues related to investigational clinical trials, observational studies, epidemiology studies, studies with medical devices, and studies with human samples.
Requirements
· Degree in Life Sciences (Biology, Biotechnology, Pharmacy, Medicine, or related).
· At least 1 year of experience in clinical start-up, ideally within a CRO, research institute, pharmaceutical, or medical device company.
· Solid knowledge of GCP and European regulatory frameworks (MDR/IVDR).
· Strong organizational skills, attention to detail, and ability to manage timelines.
· Fluency in English (spoken and written).
· Excellent interpersonal and communication skills, with a collaborative mindset.
· Motivation to work in a non-profit organization, driven by mission and social impact rather than profit.
· Proficient with Microsoft Office (Word, Power Point and Excel).
Responsibilities
The selected candidate will conduct the following activities:
· To classify according to the type of Study to be submitted the necessary documentation and the approval process to be followed.
· To verify the regulatory adequacy of the documentation produced
· To manage the submission of the study, preparing the documentation to be submitted to the Ethics Committees and the Competent Authority, both in approval and amendment phases (CTIS/RSO/CET portals)
· To follow the regulatory/administrative process for the Study’s approval by the Ethics Committees and Competent Authorities, with Clinical Trial Assistant/Clinical Trial Manager
· To carry out the activities necessary to obtain the approval of the Study and any amendments.
· To perform the necessary training to execute their duties and complete the Personnel Training Log.
Application Process
Interested candidates should submit their CV to veronica.giuliano@marionegri.it.
The amount of the fellowship will be commensurate with the candidate’s experience
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