Regulatory Start Up Specialist - CRO

For an important and established CRO I am currently looking for a Regulatory Start Up Specialist with at least 2 years of experience in the role.

What will you do:

• Prepare, review and submit submissions to CA, EC and other relevant authorities in order to obtain all necessary authorisations/approvals pertaining to the clinical trial conduct.
• Submission of the ongoing clinical trials to ethics committees and to AIFA through Portal of Clinical Research (Observatory);
• Sending the amendments to the studies by loading Observatory of all documentation available in the latest version authorised; Compiling the form of self-certification
• Managing work and team within a specific or broad area of site start-up such as activation, regulatory, submissions, site contracts or regulatory records;
• Advanced understanding of study objectives, study procedures and project related time lines.

Who am I looking for:

• Bachelor's / Master Degree in Health, Science or equivalent;
• Excellent knowledge of the clinical trial process;
• Advanced computer skills;
• Ability to develop accurate study related documents and coordinate a team;
• Thorough knowledge of GCP and relevant country regulations/guidelines;

If you want to know more about this opportunity submit NOW your CV to Patrick Carignano - p.carignano@nonstop-recruitment.com

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