Kamal Paul

Background

About Kamal Paul

I am a licensed RN and Clinical Research Professional with over a decade of experience in acute patient care, currently in clinical trial operations, AE/SAE documentation, and participant safety oversight in multiple trials, serving as study lead on cardiovascular trials. My background uniquely bridges clinical expertise and regulatory-aligned research, enabling me to collaborate closely with sponsors, CRAs, and IRBs to uphold protocol integrity, patient safety, and compliance with ICH-GCP and FDA guidelines. I bring focused skills in: Adverse Event (AE/SAE) assessment, documentation, and timely follow-up Informed consent process, safety monitoring, and source data verification Site initiation readiness, study start-up, and clinical systems (Veeva, CRIO, IRT, Florence, eConsent) Investigational Product (IP) and human biological sample accountability under protocol-defined procedures I continue to expand my expertise in drug development and pharmacovigilance through targeted coursework reinforcing a strong foundation in drug safety and clinical surveillance and drug monitoring. In the years, I’ve had the privilege of working across both clinical care and clinical research, with a growing focus on patient safety, regulatory compliance, and adverse event reporting, particularly through my current work on multiple Phase trials. I’m always looking to broaden my perspective on how clinical insights contribute to drug discovery, and development and lifecycle, research integrity and patient protection. I truly value conversations and meaningful collaborations with others working at the intersection of clinical research and drug safety where I can contribute to patient-centered, quality-driven clinical research and safety outcomes.