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 Leukemia team. Ensures accurate data collection, data abstraction, data entry, documentation and organization for various therapeutic and non-therapeutic studies lead by TXCH Leukemia faculty. The Data Manager will participate in on-call rotation schedule (approximately once a month) to handle issues evenings and weekends, this can be completed remotely.
- Supports daily operations for a research study or clinical trial.
- Consults with the Principal Investigator (PI) and providers regarding research data.
- Recruits, screens and enrolls study participants; ensures participant adherence to study protocol.
- 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 data, study documents and/or reports to regulatory agencies.
- Submits accurate research data via CRF to external sources in a timely manner.
- Provides appropriate and timely responses to sponsor data requests or queries.
- 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.
- Collects samples from participants.
- Collects, processes, ships, and maintains paperwork for blood and/or biological specimens according to procedures outlined in study protocol and SOPs.
- Precepts new clinical research staff.
- May screen for research patients.
- Collaborates with study team and physicians to assist in determining patient eligibility for research protocols.
- Prepares study-specific reports and queries for investigators and administrators.
- Effectively prioritizes and manages work activities according to study protocol.
- Consults with team members to ensure study time-points are met.
- Volunteers to assist team with overflow duties.
- Seeks guidance from Clinical Research Manager for additional assignments.
- Bachelor's degree.
- Two years of relevant experience.
- Requires effective verbal and written communication skills.
- Requires proficiency with computers, internet and Microsoft Office applications.
- May require experience with computer spreadsheets and database management.
- May require the ability to understand and implement patient studies and protocols.
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.
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