Job Description

Senior Clinical Research Associate (Medical Device Focus)

Location: Remote (Bay Area preferred)

Employment Type: Full-Time

Salary Range: $122,000–$166,000 + Bonus and Equity

Are you an experienced Clinical Research Associate with a passion for advancing innovation in medical technology? We’re looking for a Senior CRA to take ownership of site monitoring and clinical operations across a portfolio of high-impact medical device trials.

About the Role

You will independently manage all aspects of site monitoring—from qualification through close-out. You'll be the main point of contact for investigative sites, ensuring compliance with regulatory guidelines, supporting clinical trial execution, and maintaining an audit-ready environment.

This role is a great fit for someone with a strong understanding of FDA, ICH-GCP, and ISO 14155, and hands-on experience in medical device clinical trials.

Key Responsibilities

• Conduct site qualification, initiation, monitoring, and close-out visits
• Ensure proper source data verification, informed consent, and investigational product accountability
• Maintain strong site relationships and resolve issues proactively
• Draft monitoring visit reports and maintain trial documentation in the TMF
• Collaborate with cross-functional teams including Regulatory, Data Management, Quality, and Project Management
• Support protocol and CRF development, and participate in audits or inspections
• Mentor junior CRAs or CTAs as needed

Qualifications

• Minimum 5 years of clinical research experience with independent site monitoring
• In-depth knowledge of FDA regulations, ICH-GCP, and ISO 14155
• Experience in medical device trials strongly preferred
• Proficiency with CTMS, EDC, and eTMF systems
• Bachelor’s degree in Life Sciences, Nursing, or a related field (advanced degree or certification preferred)
• Willingness to travel up to 35% for site visits

Why Apply

• Remote flexibility, with preference for candidates based in the Bay Area
• Competitive compensation aligned with Bay Area market data
• Bonus, equity, and comprehensive benefits
• Collaborative, high-growth environment with real impact on patient outcomes

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