Clinical Data Coordinator
Boulder, COContractor
Behavioral Health Market Context
Apply Nowvia LinkedIn
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.
• 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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