Senior Clinical Research Associate - CNS/Oncology - West Coast

📋 Description

• • Manage end-to-end clinical research activities at investigative sites participating in CNS and oncology clinical trials, including site identification, initiation, monitoring, and closeout phases
• • Conduct study initiation visits (SIVs) to ensure sites are fully prepared to conduct the trial in compliance with protocol, GCP, and regulatory requirements
• • Perform remote site monitoring activities while ensuring adherence to informed consent procedures, safety event reporting, and data integrity standards
• • Collaborate with sites to collect, review, and maintain essential regulatory documents for study start-up and ongoing compliance
• • Support negotiation and execution of site contracts and budgets in coordination with internal legal and finance teams
• • Train site staff on proper data collection techniques, use of EDC systems, and timely reporting of adverse events and protocol deviations
• • Maintain accurate and up-to-date Trial Master File (TMF) documentation in alignment with regulatory expectations
• • Utilize CTMS and EDC systems to monitor site performance, data quality, and enrollment progress
• • Work independently with minimal supervision while maintaining strict attention to detail and regulatory compliance
• • Travel regionally across the West Coast to conduct on-site visits as required by protocol or regulatory needs
• • Serve as the primary point of contact between Worldwide Clinical Trials and clinical sites, ensuring clear and effective communication
• • Participate in regular coaching and development conversations with Line Manager to support career progression toward Clinical Trial Manager roles
• • Contribute to a collaborative, team-oriented culture focused on advancing scientific breakthroughs for patients with CNS and oncology conditions
• • Ensure all activities align with Worldwide’s mission to improve patient lives through innovative, high-quality clinical research
• • Adhere to all applicable federal, state, and international regulations including FDA, EMA, and ICH-GCP guidelines
• • Maintain proficiency in Microsoft Office Suite for reporting, documentation, and communication purposes
• • Support internal CRAs and regulatory teams on projects with high site management demands
• • Demonstrate superior organizational skills to manage multiple sites and studies simultaneously under tight timelines
• • Uphold Worldwide’s commitment to diversity, inclusion, and equal opportunity in all professional interactions