CRA Level I

Clinical Research Associate I performing remote or on-site monitoring to assess protocol and regulatory compliance, manage regulatory documentation, and ensure data reliability. Responsibilities include monitoring investigator sites with a risk-based approach (SDR/SDV/CRF review), conducting physical inventory and records review of investigational products, documenting observations in reports, escalating issues to clinical management, and coordinating with sponsors and investigative sites. Requires collaboration across project teams, adherence to ICH-GCP and SOPs, and travel to sites (frequent travel up to 60-80%). Education/experience includes a life sciences bachelor’s degree or RN-equivalent and 2 years of clinical monitoring experience, with strong communication skills and familiarity with clinical trial processes and terminology.