Personalis, Inc. is seeking a Clinical Research Associate 2 to manage clinical operations projects related to oncology molecular testing and clinical studies. The candidate will focus on biospecimen management, GCP documentation, and compliance while collaborating with various teams and external partners
Job Summary
The Clinical Research Associate is responsible for managing clinical operations projects, which includes biospecimen management, GCP documentation, and compliance requirements related to Personalis clinical research studies and CRO partnerships.
This individual will require an understanding of oncology molecular testing using Next Generation Sequencing (NGS) platforms, medical devices, and will interact with external partners to execute clinical operations, monitoring, regulatory, and clinical quality documentation.
Personalis, Inc. is a leader in advanced cancer genomics for enabling the next generation of precision cancer therapies and diagnostics.
Matching Summary
Match Score: 85
Personalis, Inc. is seeking a Clinical Research Associate 2 to manage clinical operations projects related to oncology molecular testing and clinical studies. The candidate will focus on biospecimen management, GCP documentation, and compliance while collaborating with various teams and external partners.
Skills & Requirements
Must-have
Manage clinical operations projects
Biospecimen management
GCP documentation
Oncology molecular testing
NGS platforms
CRO partnerships
Nice-to-have
Adapt to complex understanding of cancer
Precision cancer therapies and diagnostics
Big data, scale and efficiency
Key Requirements
BS or MS in biological science, computer science or a related field
2+ years in clinical operations for medical devices
Experience with regulated environments (IRB, FDA, CAP/CLIA)
Familiarity with EDC and TMF
Experience with clinical study monitoring
Experience with GCP and clinical quality compliance