Clinical Data Coordinator

Katalyst CRO

Boulder, COContractor

Behavioral Health Market Context

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Job Description

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• Generate data listings and summaries for interim and final study reports.
• Ensure data handling is in compliance with GCP, ICH guidelines, and applicable regulatory requirements.
• Maintain study documentation, audit trails, and data queries logs.
• Participate in cross-functional study team meetings and contribute to project timelines.

Requirements:
• Bachelor's degree in life sciences, healthcare, information technology, or related field.
• 13 years of experience in clinical data management or a related clinical research role.
• Familiarity with EDC systems (e.g., Medidata Rave, Oracle Clinical, redcap).
• Knowledge of GCP, ICH, and regulatory guidelines.
• Excellent attention to detail, organizational, and communication skills.
• Proficiency in Microsoft Excel and other data management tools.

Qualifications

  • Bachelor's degree in life sciences, healthcare, information technology, or related field
  • 13 years of experience in clinical data management or a related clinical research role
  • Familiarity with EDC systems (e.g., Medidata Rave, Oracle Clinical, redcap)
  • Knowledge of GCP, ICH, and regulatory guidelines
  • Excellent attention to detail, organizational, and communication skills
  • Proficiency in Microsoft Excel and other data management tools

Benefits

    Responsibilities

    • Collect, enter, and manage clinical trial data using electronic data capture (EDC) systems
    • Perform data validation and query management to ensure data quality and compliance with study protocols
    • Assist in the development of case report forms (CRFs) and data management plans (DMPs)
    • Conduct ongoing data review and discrepancy resolution in collaboration with clinical staff
    • Generate data listings and summaries for interim and final study reports
    • Ensure data handling is in compliance with GCP, ICH guidelines, and applicable regulatory requirements
    • Maintain study documentation, audit trails, and data queries logs
    • Participate in cross-functional study team meetings and contribute to project timelines


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