Angela Anton

Dynamic and accomplished clinical research expert with extensive experience in operational and administrative support within both academic and pharmaceutical environments. Demonstrates exceptional proficiency in clinical trial project management, risk-based monitoring, and regulatory compliance, consistently upholding the highest standards of data integrity and patient safety. A strategic and collaborative team player, skilled in fostering strong partnerships with cross-functional stakeholders to drive efficiency and optimize study outcomes.

WORK EXPERIENCE

Syneos Health

Centralized Monitor 2023 - 2004

• Managed and monitored Phase II-IV oncology studies. Identified Key Risk Indicators (KRIs) using real-time patient databases and vendor software (Spot Fire, RADAR, CTMS, ePROs, IRT Suvoda, IVRS/IWRS). 
• Developed Site Clinical Assessment Notifications based on findings. 
• Assessed subject safety and developed mitigation plans. 
• Ensured compliance with ICH/GCP guidelines and company SOPs. 
• Mentored junior monitors and reviewed monitoring reports.

• Managed hospitals and clinics in Phase II-IV clinical research studies. 
• Monitored site performance, procedures, processes, and results, implementing action plans as needed. 
• Served as the primary contact and company representative for assigned sites, managing communication via phone and generating Site Monitoring Calls Reports. 
• Trained site staff on study protocols, informed consent, data collection tools (EDC, IVR/IWR), AE/SAE reporting, and patient-reported outcomes instruments. 
• Maintained regulatory documentation in compliance with Essential Regulatory Document Guidelines and Trial Master File (TMF), supporting audit preparation. Supervised the receipt, handling, and storage of study medication. 
• Reviewed eCRF completion, assisting sites in resolving queries, protocol deviations, and completing Data Clarification Forms. 
• Mentored junior Clinical Monitoring Associates.

• Supported project teams to meet contractual and study expectations. 
• Utilized CTMS to manage regulatory documents, recruitment, AEs, and IRB approvals. 
• Tracked project progress, milestones, and resolved issues. 
• Presented progress and risk reports. Coordinated team meetings and action items. 
• Managed TMF and supported audits. 
• Oversaw budget, processed invoices and payments.

Research Assistant 2012

• Support and coordinate Phase II-III clinical trials for the treatment and prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE). 
• Obtained informed consent forms from patients in the ICU. 
• Ability to recognize clinical features of deep vein thrombosis (DVT) a such as limb swelling, pain, and hemodynamic instability. 
• Follow regular blood tests (INR) to monitor dosage and prevent complications.

Clinical Research Coordinator 2009-2012

• Supported and coordinated Phase II-III clinical trials for Alzheimer's disease and schizophrenia. Obtained informed consent from patients and caregivers. 
• Collected data using Clinical Trial Management Systems. 
• Determined patient eligibility and ensured treatment adherence.
• Administered assessment scales and neuropsychological tests. Submitted regulatory documents and protocols to the research committee

• Undergraduate Microprogram in Health and Social Services Management Université de Montréal 2008 
• Graduate Diploma in Drug Development, Option: Clinical Research Université de Montréal 2005
• Master of Science (MS) in Molecular Biology Université de Montréal 1998 
• Bachelor of Science (BS) in Biology Cayetano Heredia University, Lima, Peru. Comparative evaluation of studies completed outside Québec equivalent to a complete undergraduate university program, comparable to the three-year Bachelor's Degree Program.