Senior Clinical Research Associate
September 16
Description
• Conduct interim monitoring visits (IMVs) and ISF review • Review electronic medical records (EMR)/patient data • Source documentation verification (SDV) against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP and applicable regulatory requirements • Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol • Provide support to site staff including research coordinators and physicians • Assist in the development of trial materials as needed (e.g., case report forms, monitoring guidelines, site tools and training guides) • Contribute to the development of Clinical Operations SOPs, best practices, work instructions, tools and templates
Requirements
• BA/BS or equivalent with a minimum of 5+ years of relevant clinical trial management experience • Therapeutic experience in oncology/hematology and cell and gene therapy preferred • Prior CRA experience working directly for sponsor, ideally a start-up/or small company, in a leading and co-monitoring capacity • Strong working knowledge of FDA and ICH/GCP regulations and guidelines and thorough knowledge of clinical monitoring procedures • Experience with Trial Master File management according to the DIA reference model • Experience operating within various site EMR/EHR systems • Experience using eTMF, EDC (IBM Zelta experience ideal), CTMS, and other vendors systems/portals
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