Clinical Research Associate Fremont, CA

 20,000 human genes, together with the immune system, from a single tissue sample.

In population sequencing, Personalis operates one of the largest sequencing operations globally and is currently the sole sequencing provider to Veterans Affairs' Million Veteran Program. To enable cancer and population sequencing, Personalis' Clinical Laboratory was built with a focus on clinical accuracy, quality, big data, scale and efficiency. The laboratory is GxP-aligned as well as Clinical Laboratory Improvement Amendments of 1988-certified and College of American Pathologists-accredited.

Personalis is based in Fremont, California.

Days Onsite:
Monday & Tuesday (Hybrid)
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.
Responsibilities
• Lead clinical operations activities.
• Manage Clinical study operations (internal and external) in coordination with CRO, IRB, regulatory, and quality teams.
• Support the program sponsor in preparation of clinical study operations.
• Collaborate in the execution of clinical validation studies to support clinical programs.
• Oversee clinical site initiation, monitoring, and closeout activities.
• Participate in Site Monitoring activities.
• Manage CRO partnerships.
• Manage the clinical study biospecimen repository and data management.
• Track Timelines, Milestones, Deliverables, Resources, and Costs.
• Ensure internal and external milestones, deliverables, and obligations are met.
• Partner collaboratively with the Regulatory and Quality teams to ensure that all internal SOPs and compliance documentation meet quality standards.
• Take ownership of key partner-related issues and work with appropriate internal teams to resolve them.
Requirements
• BS or MS in biological science, computer science or a related field.
• Minimum of 2+ years working in industry or academics in clinical operations for medical devices.
• Experienced with products in a clinical or regulated environment (such as with IRB, FDA, CAP/CLIA etc).
• Familiarity with Electronic Data Capture (EDC) platforms and Trial Master File (TMF) organization and structure.
• Experience with Onsite or Remote clinical study monitoring
• Experience with Case Report Form (CRF) creation
• Proficiency in MS Word, Excel, and PowerPoint.
• Experience with Good Clinical Practice (GCP) and clinical quality compliance.
• Demonstrated history of successfully managing multiple concurrent initiatives.
• Strong interpersonal skills, collaboration, and problem-solving with colleagues.
• Strong communication and excellent written and oral skills.
• Detail-oriented, with solid organization and time management skills.
• Able to work under pressure, self-starter, and team player.
• Travel 0-25%.
Desired Experience
• 3+ years working in industry or academics in clinical operations for medical devices.
• 2+ years program management experience
• Experienced with products for ex-US regulatory agencies (EU, Japan, Australis etc).
• Familiarity with Electronic Data Capture (EDC) platforms and Trial Master File (TMF) setup and validation.
• Experience Metadata Statistical analysis.

The hiring range for this position is $120,000 to $145,000 per year, which may factor in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate’s geographic region, job-related knowledge, skills, and experience among other factors. Our full-time regular positions…