Clinical Research Associate 2

TL;DR

Clinical Research Associate 2 (Oncology Genomics): Managing clinical operations projects including biospecimen management, GCP documentation, and compliance for clinical research studies and CRO partnerships with an accent on oncology molecular testing using NGS platforms and medical devices. Focus on leading site monitoring, overseeing CRO partnerships, tracking timelines and deliverables, and ensuring regulatory compliance.

Location: Fremont, CA (Hybrid: Monday & Tuesday onsite). Travel 0-25%.

Salary: $120,000–$145,000 per year

Company

Leader in advanced cancer genomics enabling precision cancer therapies and diagnostics via the NeXT Platform, with a CLIA/CAP-accredited lab in Fremont, CA.

What you will do

• Lead clinical operations activities and manage internal/external study operations with CRO, IRB, regulatory, and quality teams.
• Support program sponsors in clinical study preparation and execute clinical validation studies.
• Oversee site initiation, monitoring, closeout, and participate in site monitoring activities.
• Manage CRO partnerships, biospecimen repository, and data management.
• Track timelines, milestones, deliverables, resources, and costs; ensure obligations are met.
• Collaborate with regulatory and quality teams for SOP and compliance standards; resolve partner issues.

Requirements

• BS or MS in biological science, computer science or related field.
• Minimum 2+ years in clinical operations for medical devices in industry/academia.
• Experience with regulated environments (IRB, FDA, CAP/CLIA).
• Familiarity with EDC platforms, TMF organization, CRF creation, onsite/remote monitoring.
• Proficiency in MS Word, Excel, PowerPoint; GCP and clinical quality compliance.
• Strong interpersonal, communication, organization, and time management skills; able to manage multiple initiatives under pressure.

Nice to have

• 3+ years in clinical operations for medical devices; 2+ years program management.
• Experience with ex-US regulatory agencies (EU, Japan, Australia).
• Familiarity with EDC/TMF setup/validation; metadata statistical analysis.

Culture & Benefits

• Competitive compensation with performance bonus, equity, medical/dental/vision, 401(k) match, ESPP.
• Tuition reimbursement, sick/vacation time, commuter benefits, EV charging, onsite gym, wellness benefits.
• Equal opportunity employer committed to inclusion and reasonable accommodations for disabilities.