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Key Accountabilities:
SSU Coordination and Execution
Coordinates, guides, and assists with all start up activities prior to site activation, including but not limited to: Site Informed Consent Form (“ICF”) localization and guidance in line with regulatory/health authority requirements. Ethics Committee (“EC”) information, meeting dates & costs. Ethics applications & associated online systems. Ethics & Governance submission processes. Clinical Trial Health Authority application and regulatory submission process. Contracts & Indemnity request process. For global studies, localize global ICF with country requirements. Local sample application and permit submission processes Maintains up to date knowledge, ensuring adherence and compliance with local regulatory requirements and associated documentation Reviews, analyzes, and collates metrics to ensure pr...