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Clinical Research Coordinator

vor 3 Monaten


Essen, Nordrhein-Westfalen, Deutschland Pharmiweb Vollzeit
Position Overview

The Clinical Trials Assistant (CTA) plays a crucial role in the management and execution of clinical study activities, ensuring adherence to quality and regulatory standards throughout the process.

Key Responsibilities
  • Study Coordination: Support the organization and administration of clinical trials from initiation through to completion.
  • Document Management: Assist in the collection, preparation, review, and tracking of essential documents for regulatory submissions.
  • Timely Submissions: Ensure prompt submission of necessary documents to Ethics Committees/Institutional Review Boards and relevant Regulatory Authorities.
  • Collaboration: Work closely with Investigators, external service providers, and Clinical Research Associates to facilitate effective document collection.
  • Main Contact: Act as the primary local administrative contact, collaborating with Clinical Research Associates and Local Study Administrators throughout the study duration.
  • eTMF Management: Oversee the setup and maintenance of the local electronic Trial Master File and Investigator Site File, ensuring compliance with ICH-GCP and local regulations.
  • Inspection Readiness: Ensure that all essential documents are uploaded promptly to maintain the eTMF in a state of readiness for inspections.
  • Final Archiving: Prepare all study documents for final archiving and assist in the close-out activities for the Investigator Site File.
  • Document Production: Contribute to the creation and upkeep of study documents, ensuring adherence to templates and version control.
  • Qualifications: High school/secondary school education that supports the skills necessary for this role, along with previous administrative experience in the medical or life sciences sector.
  • Skills: Demonstrated organizational and administrative abilities, proficiency in computer applications, and fluency in both spoken and written German and English.