Clinical Data Monitor I - Hybrid
HybridIrving, Texas, United States
Job Summary
Oversee clinical data management activities for sponsored and collaborating protocols, ensuring highest standards of data integrity for oncology research. Manage clinical investigative sites in accordance with GCP, GRP, ICH Guidelines, and Sponsor SOPs. Maintain proficiency in Electronic Data Capture (EDC) systems, including training, change proposals, and user acceptance testing. Perform quality control reviews of submitted Case Report Forms, conduct source document verification, and issue data queries. Serve as an evaluator for internal Clinical Research Coordinators, providing detailed feedback on training and performance. Create and manage site records within the EDC for newly onboarded sites and conduct quality control audits of the clinical database. Maintain regulatory documentation for assigned sites and study staff while collaborating with onsite teams to confirm appropriate consenting is completed. Work weekends or holidays as required.
Required Qualifications
- 3-5 years of experience in data collection activities within a GCP regulated clinical research environment
- Experience working with Electronic Data Capture (EDC) systems
- Clinical study experience in oncology
- Strong understanding of medical terminology
- Ability to work independently and make sound decisions
- Strong organizational skills with the ability to prioritize, meet deadlines, and manage multiple projects simultaneously
- Demonstrated ability to build trust with site personnel and communicate effectively with diverse stakeholders
- High attention to detail with a passion for contributing to meaningful research outcomes for patients
- Strong problem solving skills and the ability to deliver practical solutions
- Excellent written and verbal communication skills in English
- Professional demeanor with positive, collaborative interactions with internal and external partners
- Ability to propose, implement, and evaluate appropriate resolutions to issues
- Must successfully complete pre-employment process, which includes criminal background check, drug screening, credit check (applicable for certain positions) and reference verification
Desired Qualifications
- Bachelor's degree preferred
- Research Coordinator certification (SoCRA, ACRP)
- Working knowledge of human anatomy
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