Title:  Clinical Research Associate - BMT Data Management

Summary

The Texas Children’s Cancer and Hematology Centers (TXCH) Clinical Research Associate is responsible for implementing the day to day research data management activities for assigned pediatric clinical trials from start up to close out. Independently ensures accurate data collection, data abstraction, data entry, documentation and organization for various complex therapeutic and non-therapeutic studies lead by TXCH faculty.

Job Duties

• Independently oversees all aspects of research data management including the collection of source documents, development and completion of case report forms, and identification, tracking and reporting of adverse and serious adverse events. 
• Reviews and analyzes information from the medical record system (medical history, clinic notes, laboratory and pathology reports, radiology reports, patient diaries and questionnaires, etc.) to evaluate, categorize and extract data for assigned research protocols including but not limited to cooperative group, industry-sponsored and investigator-initiated studies. 
• Assesses medical record documentation relative to each study protocol to confirm subject eligibility and ensure required source documentation present in medical record or research chart. 
• Accurately captures and enters data, such as research subject registration, treatment randomization, initial and follow-up visit information and biological sample tracking, into various clinical trial databases as necessary, and within timelines set by each study sponsor. 
• Independently tracks data deadlines and milestones to ensure site compliance. 
• Generates and maintains a complete research chart for every study participant.
• Manages the collection, processing, and shipping, as well as the completion of all paperwork for blood and/or biological specimens according to the study protocol and SOPs.
• Consolidates clinical data and generates reports (number of patients with specific diagnoses, new patients for the clinic team during a given time period, etc.) for investigators as needed. 
• Attends weekly study team meetings and provides updates to the Clinical Research Lead, Clinical Research Manager (CRM) and other study team members on various data management activities, including data entry requirements, database deadlines, and query management. 
• Liaises with external sites, coordinating centers and sponsors.
• Supports the CRM in onboarding, training and serving as a resource to guide newly hired and less experienced CRAs. 
• Attends protocol related training meetings (pre-site selection visits, Site Initiation Visit, etc.) and completes all required study training. 
• Liaises with study monitors – addresses monitoring report findings, with the prompt resolution of all study related queries. Assists the research coordinator with scheduling monitoring visits.
• Prepares for and participates in internal quality control (QC) audits to verify the accuracy and completeness of research data. Develops draft report responses for PI approval. 
• Serves as a primary data contact in preparing for external audits (FDA audit, regulatory audit, etc.), addressing data discrepancies, and assists the CRM in developing corrective action plans at the completion of each audit. 
• Develops and maintains team procedures (i.e., patient enrollment workflows) and systems (ex. various electronic databases) for all data management activities. 
• Provides support to BCM Research IT team (identifying potential problems with internal study databases) to help improve our research systems.
• Maintains controls to assure accuracy, completeness, and confidentiality of research data. 
• Complies with all departmental, institutional and federal requirements, including Health Insurance Portability and Accountability Act (HIPAA) regulations and maintains confidentiality standards.
• Performs other job-related duties as assigned.

Other

• Primary data management contact for complex interventional therapeutic clinical trials, including multi-center studies and investigator-initiated trials. 
• Collaborates with multiple Principal Investigators, faculty, and other clinical and ancillary staff in the overall data coordination of each clinical trial.
• Participates in feasibility meetings to evaluate potential research studies. Provides feedback regarding the data management and reporting requirements for each potential protocol.
• Creates detailed custom and descriptive reports from the department’s internal patient registration system, for use by investigators and research leadership.

Percentage of Time Spent on Duties:

• 75% - Review and interpretation of medical source documentation. This includes items outlined in the first three bullet points in #2. 
• 15% - Research document completion – CRFs, study logs, internal reports
• 5% - Biological Sample Management
• 5% - Research Chart Organization, meetings, audit and monitoring visits

Minimum Qualifications

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

Preferred Qualifications

• Master's degree in a related field.
• Clinical research database management 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.