Regulatory Coordinator

3 weeks ago

Cerritos, United States Medix™ Full time

Regulatory Coordinator - Cerritos, CA


Schedule: Monday - Friday, 8-5

Pay: $23 - $28/hour

Location: Cerritos, CA 90703


Responsibilities

  • Handle a high volume of documents and data-heavy tasks with accuracy and efficiency. Organize, archive, and maintain essential records in accordance with company policies and regulatory requirements.
  • Ensure all activities comply with FDA regulations, HIPAA guidelines, and other applicable standards. Stay updated on regulatory changes and implement necessary adjustments to maintain compliance.
  • Process digital documents through platforms like DocuSign. Ensure electronic documents are completed, signed, and submitted correctly.
  • Review informed consent forms (ICFs) for accuracy and completeness. Work with internal teams and external partners to ensure ICFs meet regulatory and ethical standards.
  • Prepare and submit documents to Institutional Review Boards (IRBs) for review and approval. Coordinate communication with IRBs to address any queries or required revisions.
  • Conduct regular audits of document processes to ensure compliance and identify areas for improvement. Implement corrective actions as needed.
  • Collaborate with cross-functional teams to ensure seamless document processing and regulatory compliance. Communicate effectively with internal stakeholders and external partners.
  • Maintain accurate records of all document submissions, reviews, and approvals. Ensure document retention policies are followed and that data is securely stored.
  • Provide training and guidance to team members on document management practices, regulatory compliance, and digital document processing.


Qualifications:

  • Associate's/Bachelor's degree
  • 1-2 years of related regulatory experience

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