Clinical Trials Specialist

hace 2 días


Ciudad de México, Ciudad de México MEX Labcorp Clinical Development, S. de R.L. de C.V. A tiempo completo
Job Overview

MEX Labcorp Clinical Development, S. de R.L. de C.V. is seeking a highly skilled Regulatory Specialist to play a key role in the success of our clinical trials. As a Regulatory Specialist, you will be responsible for ensuring compliance with regulatory requirements and guidelines, coordinating with investigative sites, and maintaining awareness of current regulatory standards.

Key Responsibilities
  • Maintain awareness of regulatory legislation, guidance, and practice in assigned countries.
  • Coordinate, collect, and organize data and information required by EC/IRB/Third body/Regulatory Authority.
  • Compile and prepare routine submission files to IRB/IEC/Third body/Regulatory Authorities and liaise with them as applicable.
  • Liaise with internal and external vendors in the generation of Regulatory Authority submissions.
  • Perform a review of final submission documents as applicable.
  • Ensure that all assigned start-up and maintenance activities are on track, in accordance with client expectations and budget, and in compliance with applicable laws and guidelines, regulatory requirements, ICH/GCP, SOPs, and quality standards.
  • Prevent and escalate study issues appropriately and in a timely fashion.
Requirements
  • Proven experience in regulatory affairs and site activation.
  • Strong knowledge of regulatory requirements and guidelines in assigned countries.
  • Excellent communication and coordination skills.
  • Ability to work independently and as part of a team.


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