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