Clinical Data Coordinator

Katalyst CRO; Salt Lake City (UT); On-site; USD 95,000 - 125,000; Full time

Job summary

Katalyst CRO is seeking a Clinical Data Manager to join our Salt Lake City team. You will oversee data capture, validation, and query management for multiple clinical trials, ensuring accuracy and regulatory compliance.

Responsibilities include developing CRFs and data management plans, conducting ongoing data review, generating data listings, and maintaining audit trails while collaborating with cross-functional study teams to meet timelines.

Qualifications

• Bachelor's degree in life sciences, healthcare, information technology, or related field.
• 13 years of experience in clinical data management or related clinical research role.
• Familiarity with EDC systems (e.g., Medidata Rave, Oracle Clinical, REDCap).
• Knowledge of GCP, ICH, and regulatory guidelines.

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.

Skills

EDC systems

Data validation

Communication

Excel

Data management

Education

Bachelor's degree in life sciences

Tools

Medidata Rave

Oracle Clinical

REDCap

Job description

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