Anna Shavin

• Managed 50+ sites across multiple studies, ensured compliance with SOPs, ICH-GCP, FDA, and ICH guidelines
• Verified source documentation and CRFs for accuracy and protocol adherence
• Conducted remote monitoring, SIVs and COVs for assigned study sites
• Led site management reporting and EDC updates during bi-monthly client meetings
• Supported investigators with regulatory submissions and maintained compliance with local and centralized IRB/IEC requirements
• Oversaw document collection and submission to CTMS and eTMF Veeva systems
• Collaborated with site study coordinators for resolution of queries for various study deadlines
• Experienced in therapeutic areas including Obstetrics/Gynecology, Rare Disease/Endocrinology, Neurology/Parkinson’s Disease, and Oncology
• Expert in Microsoft 365, Word, Excel, PowerPoint, Adobe Acrobat, Spartan Computational Software, TMF (Veeva Vault), EDC (ZELTA, MEDNET, MEDIDATA), and CTMS
• Prepared and charted data and metrics for detailed status reports.
• Facilitated timely project completion by tracking progress, identifying potential obstacles, and providing support to team members.

Independently planned and executed multi-step syntheses of organic ligand compounds

• Utilized statistical packages to analyze data and create visualizations.
• Led Lab lectures and directed students in laboratory procedures and proctored exams
• Managed preparation of chemicals, hazardous waste disposal, and lab equipment according to regulatory standards
• Gathered and organized information for research purposes.
• Conducted thorough literature reviews to identify gaps in knowledge and inform future research directions.
• Synthesized large volumes of information, identifying key trends and patterns relevant to research objectives.
• Managed multiple research projects simultaneously, ensuring timely completion within budget constraints.