Pattern Bioscience is tackling antibiotic resistance, a major public health challenge, by using machine learning and microfluidics to identify bacteria and predict effective drugs. They need a Clinical Research Document Coordinator to manage documentation for clinical trials and external partnerships across multiple internal lab sites.
Requirements
- Possess basic clinical lab knowledge, especially clinical microbiology
- Resourcefully navigate digital and physical document storage systems and other software-related tools
- 1-2 years of previous data entry experience as a clinical research coordinator, clinical research assistant or data entry specialist for clinical trials
- Knowledge of regulations governing clinical research (CFR, GCP, HIPAA)
Responsibilities
- Confirm completion of case report forms by site staff
- Coordinate the workflow of physical documentation
- Assemble clinical trial site binders
- File documentation into internal sites’ Trial Master Files
- Responsible for Electronic Data Capture (EDC) data entry and management which is essential for daily clinical research operations
- Perform daily EDC query resolution with minimal errors
- Perform auditing and review of EDC entries to ensure compliance standards are maintained
Other
- Maintain document confidentiality at all times, understand and comply with the appropriate sponsor requirements and regulations which includes the Food and Drug Administration, Good Clinical Practices, Health Insurance Portability and Accountability Act, institutional review boards, and institutional policies and procedures
- Are exceptionally detail-oriented and organized with an affinity for efficiency
- Manage small projects and work independently
- Understand and interpret clinical research protocols and other applicable sponsor documents
- Communicate clearly and proactively
