Job Description

Summary

The Clinical Research Associate is responsible for the data management activities of complex clinical trials and research protocols for the Department of Pediatrics, Center for Research Advancement (CRA). Primary responsibilities include data extraction and reporting of research patient data.

Job Duties

• Responsible for electronic case reporting requirements in accordance with all FDA and clinical trial study requirements. 
• Manages and enters study information into CTMS (clinical trial management system) database. 
• Manages clinical trial databases independently. 
• Provides guidance to investigators and other research staff and serves as a source of expertise for data management projects, concepts and approaches. 
• Develops management plans to ensure timeliness and accuracy in data entries and reporting. 
• Oversees submission of adverse event and serious adverse event reporting and follow-ups, as needed. 
• Adheres to Baylor College of Medicine, Texas Children’s Hospital and Clinical Research SOPs and Good Clinical Practices (GCP). 
• Ensures scientific integrity of data and protects the rights, safety, and well-being of patients enrolled in clinical trials. 
• Collaborates with research on highly demanding complex clinical studies involving rapid scale up and high volumes of patients/participants with intensive data extraction and entry requirements.
• Performs other job-related duties as assigned.

Minimum Qualifications

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

Preferred Qualifications

• Master's degree in a related field. 
• Prior experience working in an academic research setting.
• Ability to understand and manage the complexities of clinical trials and research protocols, including issues related to informed consent, access to data, and conflict of interest.

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

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