Regulatory Compliance Specialist

hace 2 meses

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

MEX Labcorp Clinical Development, S. de R.L. de C.V. is seeking a highly motivated and detail-oriented Regulatory Compliance Specialist to join our team. As a key member of our clinical development team, you will be responsible for ensuring compliance with regulatory requirements and guidelines in the assigned countries.

Key Responsibilities
  • Maintain awareness of regulatory legislation, guidance, and practice in the assigned countries.
  • Coordinate, collect, and organize data and information required by regulatory authorities, including the preparation of study documentation.
  • Compile and prepare routine submissions filed to regulatory authorities and liaise with them regarding submission/approval.
  • Liaise with internal and external vendors in the generation of regulatory authority submissions.
  • Perform a review of final submission documents.
  • 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.
  • Perform other duties as assigned by management depending upon country and situational requirements with proper supervision.
Country-Specific Tasks
  • Serve as primary contact for investigative sites and ensure documents required are collected in a timely manner.
  • Collect and track all necessary documents required and perform a quality review, formatting, and compilation of the final documents for effective and compliant site activation and maintenance without supervision.
  • Ensure high-quality documents are filed and systems are updated on an ongoing and timely basis, making the company ready for an audit at any time.
  • Participate in team and project meetings as applicable.
  • When needed, assist in the strategy definition for Site Activation and provide accurate projections and timelines to study teams.
  • Review and customize country and site-specific patient informed consent forms for compliance with local requirements and protocol. Proactively resolve informed consent issues and other potential difficulties with study sites.
  • May support the negotiation of site contracts and budgets with sites, if applicable, and track progress of contract and budget milestones/developments, intervening and escalating as appropriate.
  • Proactively identifying and escalating to Submission Leads any risk to meeting deliverables.
  • Notify the Submissions Lead of hours identified as Out-of-Scope or overburn.
  • Clinical Trials Information System (CTIS) tasks (specific centralized role for EU): Assist in the upload of submission documentation to, interacting with, and monitoring of all notifications and alerts in CTIS to ensure all milestones and events for the trial are met within the timelines mandated.

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