Kaivalya R.

WORK HISTORY

EDUCATION

ABOUT KAIVALYA R.

I am a fresh Pharm D graduate, CSIR-UGC NET (2024) qualified and emerging Clinical Research professional with robust onsite experience in 11+(Phase II–IV, RWE) clinical trials across Neurology, Immunology, Cardiology and Obstetrics & Gynecology. Currently working as a Lead Clinical Research Coordinator & Ethics Committee Coordinator, I support full-spectrum site operations while ensuring compliance, quality and patient safety.With strong exposure to protocol implementation, monitoring support, regulatory documentation, EC submissions, source data verification, data quality checks and EDC platforms (Medidata Rave, Inform, VData, CodeAngelo, Diagnosearch), I bring the practical site-level understanding that CROs and sponsors look for in a high-potential CRA.I have completed 35+ Feasibility Questionnaires, supported study start-up activities, contributed during SQVs, IMVs and SMVs and handled IWRS, audit responses and continuous site readiness. I also have hands-on experience in ADR monitoring, narrative writing, medical documentation and cross-functional coordination—skills that additionally align with Medical Affairs, Medical Information and Scientific Communication roles.Alongside clinical operations, my strong scientific background includes published research, antibiogram development, case reports and medical journalism, enabling me to translate complex medical concepts into clear, evidence-based insights. What I Bring (CRA-Ready Skillset):• Strong understanding of ICH-GCP, protocol adherence & site operations• SDV, source documentation, query resolution & risk-based approaches• IRB/EC coordination & regulatory documentation• EDC proficiency (Medidata Rave, Inform Oracle, VData, CodeAngelo)• Excellent communication, stakeholder engagement & on-site troubleshooting• Readiness to travel, adapt and take operational ownership Interest Areas Clinical Research Associate (CRA) Clinical Operations / Site Management Medical Affairs & Medical Information Scientific/Medical Communication Pharmacovigilance / Safety OperationsI am driven by the vision of strengthening clinical trial quality, patient safety and evidence-based healthcare in India and I am now seeking opportunities with leading CROs and pharmaceutical sponsors where I can contribute meaningfully while continuing to grow professionally.If your organization values detail-oriented execution, continuous compliance and a patient-centered approach to research—I would be glad to connect.