Germany Job Openings

Clinical Trial and Consulting Services

Regulatory Affairs Coordinator (m/f/d)

Ulm

FULL TIME

November 19, 2024

Job Purpose/Summary
This position is responsible for providing regulatory administrative support to the Regulatory Specialists in the CTI European Headquarter in Ulm/Germany. Duties will include entry and tracking of trial related regulatory documentation, assist in study start-up and maintenance activities
What You’ll Do
  • Assist in compilation and revision of Regulatory Affairs (RA) documents required for clinical trials submissions.
  • Assist in the contact with local study teams for RA documents collection and checks, when applicable,
  • Assist in preparation of study submission packages (Initial Submissions, Substantial Amendments and Non-substantial Amendments) to Ethics and Competent Authority.
  • Arrange for shipments of regulatory documents and packages, track and retrieve items, when needed
  • Assist in SUSARs submission package preparation to Central and Local Ethics Committees as well as Competent Authorities in applicable countries
  • Assist in the preparation and completion of specific trackers
  • Assist in the filling of the submissions packages in the study systems and CTI study drive, as applicable
What You Bring
  • Minimum of 6 months clinical research or research related experience.
  • Bachelor’s Degree in allied health fields such as nursing, pharmacy or health / natural science
  • Excellent English and German Language Skills
This position is a limited contract for currently 18 months - extension possible.
Job Type: Full-time
Work Location: Hybrid remote in 89077 Ulm
Expected Start Date: 01/01/2025
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