Princy Mathai

Supported CRF development, IRB submissions, site management, and maintained audit-ready documentation to ensure compliance with ICH-GCP, FDA, and sponsor requirements. Designed and delivered onboarding and clinical training programs that improved cross-functional readiness and patient-facing education for oncology trials.

Performed real-time in-house review of study outputs to identify data gaps and ensure standards compliance while collaborating with sponsors and vendors to resolve issues and mitigate project risk. Synthesized cross-functional feedback and escalated high-impact issues to maintain study continuity.

Monitored device clinical trials through pre-study, initiation, and routine site visits, ensuring ICH-GCP and sponsor compliance and facilitating audit preparation and resolution. Conducted CRF review, query resolution, and electronic data capture management to maintain data integrity.

Conducted pre-study, initiation, and routine monitoring visits for a liver transplant trial, ensuring protocol and regulatory compliance. Managed site query resolution, collaborated with project management on budgets and invoicing, and trained new CRAs to support trial continuity.

Coordinated communications with sites, investigators, IRBs, and vendors to support patient enrollment, drug inventory, and trial progress. Maintained trial management files, supported CRF review and data query reporting, and produced site communications to support study operations.

Earned a Bachelor of Science in Biology and Secondary Education from Eastern University.