Clinical Research Associate

Onsite 3 days a week in San Francisco, CA 6+ month contract with likelihood of extension About the Role Seeking an experienced Clinical Research Associate to support laboratory-based clinical studies. This role is responsible for monitoring clinical sites, ensuring regulatory compliance, supporting laboratory operations, and collaborating with internal teams and external partners to drive successful clinical trial execution. Key Responsibilities Perform all phases of site monitoring, including site qualification, initiation, routine monitoring, and close-out visits. Monitor laboratory activities, sample processing, data quality, and protocol compliance. Ensure compliance with GCP, ICH guidelines, 21 CFR Part 812 (IDE), and study SOPs. Review essential study documents and maintain inspection-ready trial files. Prepare monitoring reports, track study progress, and communicate updates to study teams and sponsors. Support study management, data collection, query resolution, and cross-functional project activities. Ensure study staff are properly trained and patient safety and informed consent requirements are met. Qualifications Bachelor's degree in Life Sciences or a related field (Master's preferred). 2–5+ years of CRA experience, preferably in IVD, diagnostics, or laboratory-based clinical trials not required. Hands-on experience with 21 CFR Part 812 (IDE) and GCP/ICH guidelines. Strong understanding of laboratory workflows and clinical trial monitoring.