Senior Clinical Research Associate - CNS/Psychiatry - West Coast - Remote

📋 Description

• • Manage clinical research activities at investigator sites participating in CNS and psychiatry clinical trials across the West Coast
• • Perform all stages of clinical study execution, including site identification, regulatory document collection, contract and budget negotiation, and site training on data collection and safety reporting
• • Conduct Study Initiation Visits (SIVs) to ensure sites are fully prepared to execute trial protocols
• • Monitor site compliance with informed consent procedures, adverse event reporting, and all applicable FDA, ICH-GCP, and local regulatory requirements
• • Perform remote site monitoring activities as the primary mode of oversight, with occasional regional travel required for on-site visits
• • Maintain accurate and up-to-date Trial Master Files (TMFs) and ensure regulatory documentation is complete and compliant
• • Collaborate with internal teams including Clinical Trial Managers, Data Management, and Regulatory Affairs to support smooth trial operations
• • Utilize CTMS and EDC systems to track site performance, data quality, and study milestones
• • Ensure timely resolution of site issues, including protocol deviations, missing data, and compliance gaps
• • Serve as the primary point of contact between Worldwide and clinical sites, providing guidance and support throughout the study lifecycle
• • Maintain detailed documentation of all monitoring activities, findings, and follow-up actions in accordance with company and regulatory standards
• • Participate in regular coaching and development conversations with Line Manager to support career progression toward Clinical Trial Manager roles
• • Adhere to Worldwide’s commitment to quality, innovation, and patient-centered clinical research
• • Work independently with minimal supervision while maintaining high standards of accuracy, timeliness, and regulatory compliance
• • Contribute to a collaborative, inclusive, and diverse team environment focused on advancing treatments for CNS and psychiatric disorders
• • Support global clinical trial objectives while operating within the West Coast region and adhering to regional regulatory expectations
• • Ensure all activities align with Worldwide’s mission to improve patient lives through pioneering clinical research