Saikrupa Chinthakunta

Manage Phase II–IV regulatory operations, including IRB submissions, amendments, continuing reviews, safety reports, study closures, FDA Form 1572, IND support, ICFs, investigator brochures, and sponsor correspondence. Coordinate protocol and site feasibility, track site start-up critical paths, and develop dashboards for feasibility, enrollment, and portfolio KPIs.

Coordinated Phase II–IV clinical trials, managing study start-up, patient screening, recruitment, enrollment, informed consent, study visits, and protocol implementation. Conducted feasibility assessments using Epic SlicerDicer, maintained regulatory and clinical data across Epic, Advarra, OnCore, REDCap, and eReg, and developed dashboards to track enrollment and milestones.

Supported Phase II–IV clinical research across oncology and other therapeutic programs, coordinating screening, consent, study visits, investigator communication, specimen workflows, and safety follow-up. Maintained regulatory binders, IRB correspondence, consent versions, and audit-ready study trackers.

Supported clinical research documentation, informed consent, participant tracking, source/CRF reconciliation, investigator communications, regulatory files, laboratory logistics, and protocol compliance.

Master of Science in Health Data Science from Saint Louis University.

Bachelor of Dental Surgery (BDS) from Dr. NTR University of Health Sciences.

Completed CITI Biomedical Research and Clinical Research Coordinator Training.

Completed Adult & Pediatric First Aid/CPR/AED training.