Clinical Research Regulatory Coordinator 242975 Job at Medix™, Springfield, MA

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  • Medix™
  • Springfield, MA

Job Description

Responsibilities :

  • Prepares and submits regulatory documents to IRBs and sponsors independently.
  • Maintains regulatory binders electronically and in the CTMS in compliance with regulations governing clinical research GCP and site SOPs.
  • Drafts and revises ICFs, site-specific regulatory forms, and other regulatory documents.
  • Coordinates responses to IRB queries and sponsor requests for information.
  • Serves as the primary regulatory point of contact for assigned studies.
  • Participates in internal audits and regulatory reviews.
  • Supports and mentors Regulatory Assistants in task completion and training.
  • Monitors document version control and conduct routine regulatory QC checks.
  • Occasional travel to Company sites, Investigator meetings, and/or Company meetings as required.
  • Performs other miscellaneous job-related duties as assigned by their manager.

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