Katalyst CRO

Clinical Data Coordinator

Katalyst CRO Boulder, CO
Katalyst CRO

Clinical Data Coordinator

Katalyst CRO Boulder, CO
4 months ago 30 applicants

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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.

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.

  • Seniority level

    Associate

  • Employment type

    Contract

  • Job function

    Research, Analyst, and Information Technology

  • Industries

    Pharmaceutical Manufacturing

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