Note: The job is a remote job and is open to candidates in USA. Zachary Piper Solutions is seeking a Senior Clinical Research Associate to join a global leader in clinical research and healthcare analysis. The role involves monitoring oncology clinical trials, ensuring site and regulatory compliance, supporting recruitment, providing protocol training, and tracking study progress.
Responsibilities
- Conduct site monitoring visits to ensure compliance with GCP, ICH, and regulatory guidelines
- Support subject recruitment and adapt recruitment plans as needed
- Provide protocol training and manage communication with study sites
- Assess site adherence to protocol and regulatory requirements, reporting quality issues
- Track study progress, including regulatory approvals, enrollment, data collection, and query resolution
Skills
- Minimum 3 years of recent on-site monitoring experience within Oncology (Phase I – solid or liquid tumor)
- Proficiency in CTMS, EDC, and Microsoft Office Suite
- Strong knowledge of GCP, ICH guidelines, and regulatory requirements
- Experience in site management, patient recruitment, and clinical trial documentation
- Bachelor's degree in life sciences, nursing, or a related field
- Advanced degree preferred
Benefits
- Medical
- Dental
- Vision
- Sick leave if required by law
- 401K
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