Clinical Research Associate - Data Manager for Hematology/Oncology

Summary

The Texas Children's Cancer and Hematology Centers (TXCH) Clinical Research Associate is responsible for implementing and coordinating the day to day research data management activities of pediatric protocols on the Developmental Therapeutics team. Ensures accurate data collection, data abstraction, data entry, documentation and organization for study files and online systems.

This position is on-site, Monday - Friday.

Job Duties

• Supports daily operations for a research study or clinical trial.
• Consults with the Principal Investigator (PI) and providers regarding research data.
• Collaborates with study team and physicians to assist in determining patient eligibility for research protocols.
• Consults with team members to ensure study time-points are met.
• Assists the PI and/or provider with study patient enrollment.
• Collects, evaluates, enters and tracks data.
• Collects research patient information (i.e. medical history, labs) from the electronic medical record (EMR).
• Maintains accurate source documentation and case report forms (CRFs) per protocol.
• Submits accurate research data via CRF to external sources in a timely manner.
• Provides appropriate and timely responses to sponsor data requests or queries.
• Submits data, study documents and/or reports to regulatory agencies.
• Assists with completion of protocol-specific documents.
• Monitors protocol compliance and appropriately communicates errors or deficient source documentation.
• Establishes study files and prepares and oversees study-related documentation.
• Creates and maintains research charts.
• Updates internal and external databases per departmental, sponsor, or study requirements.
• Precepts new clinical research staff.
• Prepares study-specific reports and queries for investigators and administrators.
• Effectively prioritizes and manages work activities according to study protocol.
• Volunteers to assist team with overflow duties.
• Seeks guidance from Clinical Research Manager for additional assignments.

Minimum Qualifications

• Bachelor's degree.
• Two years of relevant experience.

Baylor College of Medicine requires employees to be fully vaccinated -subject to approved exemptions-against vaccine-preventable diseases including, but not limited to, COVID-19 and influenza.

Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.

15449

CH; SN