Position Title: Senior Clinical Research AssociateAbout the OrganizationThis international biotech company is dedicated to advancing therapies for individuals with rare and complex medical conditions that are not readily addressed by existing treatments. With one approved product and a robust pipeline of clinical studies, the company continues to grow-achieving consistent revenue increases and delivering breakthrough solutions for patients with limited options. Join a dynamic and talented team that values innovation, collaboration, and a strong people-first culture. Apply today to be part of a mission-driven organization making a real difference.Role SummaryThe SR. CRA will play a key role in supporting clinical development and post-market activities. This position involves coordination with study sites, document management, and ensuring compliance with regulatory and quality standards.Primary ResponsibilitiesServe as a liaison between clinical sites and internal teams for both investigational and marketed productsOversee collection and maintenance of essential regulatory and trial documentationMonitor safety data and support pharmacovigilance reporting processesCoordinate logistics for clinical supplies and site paymentsTrack project timelines and site performance metricsPrepare submissions for ethics and regulatory bodiesParticipate in internal and external meetings, including investigator and audit sessionsContribute to internal communications and knowledge-sharing initiativesKey Performance IndicatorsTimely resolution of site-level issuesAccuracy and completeness of clinical documentationSupport for safety and quality investigationsMaintenance of organized and audit-ready trial filesQualifications & ExperienceBachelor's degree in life sciences, nursing, pharmacy, or a related discipline (advanced degree preferred)Familiarity with international clinical research standards (e.g., ICH-GCP)Prior experience in clinical operations, site management, or regulatory affairsWhat You'll GainCompetitive compensation and benefits packageExposure to global clinical development and commercial operationsOpportunities to collaborate with leading experts in the fieldA dynamic, mission-driven work environment Reports To:* Clinical Programs Manager* Regional Operations Director* Clinical Affairs SupervisorEmployment Type: Full-Time, PermanentLocation: San Francisco Bay Area (Hybrid: Remote with On-Site Requirements)Work Schedule: Monday-Friday, 9:00 AM - 5:00 PMTravel: Occasional domestic travel requiredCompensation - $110K - $130K
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