Rishitha P

I’m a Clinical Research Coordinator with over 5+ years of progressive experience supporting Phase I through IV clinical trials in hospital and health system settings. I began my career in India performing hands-on clinical and administrative trial tasks, then transitioned into a US-based coordinator role with broader regulatory, sponsor, and data-quality responsibilities.

In my current role (Allucent), I manage day-to-day operations for multiple active trials, ensuring study activities follow the protocol, FDA regulations, and ICH-GCP guidelines. I serve as the primary sponsor and CRA contact during monitoring visits, and I keep regulatory binders and trial master files organized and audit-ready.

I’m hands-on across the participant journey—screening against inclusion/exclusion criteria, conducting informed consent, coordinating visits, collecting vitals, administering procedures, and maintaining accurate documentation. I also oversee investigational product receipt, storage, dispensing, reconciliation, and return with accountability logs and temperature records.

I focus on compliance and patient safety through timely adverse event (AE) and serious adverse event (SAE) reporting, protocol deviation reporting, and readiness for sponsor monitoring and internal audits. I combine clinical trial execution with analytics tools such as SAS, Python, SQL, Tableau, and electronic data capture (EDC/eCRF) to resolve data queries and protect data integrity.