Clinical Trial Specialist (San Rafael)

Senior Study Specialist, Global Study Operations 6-month Contract Hybrid in San Rafael, CA Key Responsibilities Support development of study-specific documentation and operational plans Contribute to country and site feasibility assessments and site selection activities Oversee CRO activities related to IRB/EC submissions and approvals Manage essential study documents across the full study lifecycle Support development and delivery of site and investigator training materials Present at investigator meetings, as needed Ensure accuracy and timeliness of study-related documentation and tracking Oversee clinical trial insurance processes Participate in cross-functional study execution, vendor, and internal team meetings Manage study postings and updates on clinical trial registries (e.g., ClinicalTrials.gov) Facilitate and track study-related documentation (e.g., screening authorizations, signatures) Identify operational risks and contribute to mitigation strategies Provide operational and administrative support for internal and external meetings Study Operations & Execution Maintain end-to-end understanding of clinical trial operations, including start-up, maintenance, and close-out Understand clinical trial lifecycle milestones, critical path dependencies, and inspection readiness expectations Independently manage complex operational workstreams with minimal oversight in a fast-paced environment Systems & Tools Experience with clinical systems, including: TMF/eTMF systems (ensuring quality, completeness, and inspection readiness) EDC systems (understanding operational interfaces and timelines) IRT/IXRS and eCOA/ePRO platforms, as applicable Track vendor milestones, site performance, and KPIs Utilize collaboration tools such as Microsoft Teams and SharePoint Maintain high standards for system accuracy, reconciliation, and data integrity Core Competencies Agility and proactivity Strong communication and collaboration skills Leadership and ability to influence cross-functional teams Technical Competencies Clinical study management and execution Compliance, quality, and regulatory awareness Understanding of drug development and study design Therapeutic area knowledge Qualifications Bachelor’s degree in life sciences, health sciences, or related field preferred (or equivalent experience) Experience within a biotechnology, pharmaceutical, or clinical research environment Prior experience managing external vendors (e.g., CROs, central labs, imaging vendors), including scope, budgets, and invoices