Kym Raphino

Clinical Trial Document Specialist @Zenas BioPharma

US

Clinical Research Professional | Regulatory & Trial Documentation Specialist | Cross-Functional CollaboratorAs a dedicated clinical research professional, I bring hands-on experience in supporting the end-to-end execution of clinical trials — from study start-up through closeout. I work closely with clinical study teams and cross-functional partners to ensure the integrity, accuracy, and compliance of study documentation and processes. My key focus areas include: • Comprehensive review of study protocols, CRFs, ICFs, and related materials to ensure deep understanding of investigational products and study procedures. • Oversight of clinical documentation, including the preparation, distribution, filing, and archiving of trial materials in accordance with SOPs, GCP, and ICH guidelines. • Coordination of regulatory submissions and the collection and review of site-level documentation. • Preparation of trial tools and templates to support study start-up and conduct. • Supporting project management by tracking study metrics, managing timelines, scheduling key meetings, and documenting action items. • Assisting with contract and budget distribution, invoice tracking, and vendor management. • Ensuring quality and compliance of the Trial Master File throughout the trial lifecycle.I thrive in dynamic, detail-oriented environments where quality, collaboration, and compliance drive success. My goal is to contribute to efficient and impactful clinical research that ultimately improves patient outcomes.