Deepika K.

About Deepika K.

I’m a Clinical Research Professional with hands-on experience in on-site and remote study coordination, promoted to Clinical Research Associate (CRA) within the same organisation. I’ve managed multicentric Real-World Studies and disease registries, spanning rheumatoid arthritis, oncology, CKD, critical care, and infectious diseases, enrolling patients across 30+ sites for global and Indian sponsors like Pfizer, Cipla, Zydus and Parexel.I began my career as an on-site CRC, independently managing Phase IV CKD studies, overseeing patient screening, informed consent, AE/SAE reporting, IP accountability, EDC data entry, lab/vendor coordination, and site audit readiness, contributing to 100% compliance during monitoring visits.As a remote CRC, I coordinated multi-site RWS and registry studies, performing EDC setup, data QC, recruitment tracking, and interim analysis, supporting 15+ monitoring visits and ensuring 98–100% query resolution on time. My consistent performance led to my promotion to CRA, where I now handle:Travelling for monitoring and close-outsCompletion of a study end-to-end — from dossier preparation, initiation, interim analysis support, to data lock and closureMonitoring visits for 30+ active sitesAE/SAE review and timely reporting for 500+ patientsISF/TMF reconciliation EC dossier preparation and submissionsSite training on GCP, protocol updates, and EDC usageFinance coordination: site payments and invoices worth ₹90+ lakhsParticipation in client meetings and study progress updatesCross-functional coordination with medical monitors, safety, biometrics & data managementSite staff training (protocol updates, GCP, EDC, deviation prevention)Troubleshooting lab shipment, EDC access, and operational issuesRisk-based monitoring and continuous quality oversightIn parallel, I spent over a year in full-time medico-marketing medical writing, creating scientific content, campaign concepts, slide decks, patient materials, and synopses, collaborating with cross-functional teams and participating in 10+ client meetings for strategy alignment. I am currently also freelancing as a medical writer on weekends, continuing to support healthcare brands and scientific communications.This combination of clinical research and medical writing expertise enables me to deliver high-quality, compliant, and timely study execution, and I’m now focused on transitioning into interventional clinical trials, leveraging my RWS and CRA experience to add measurable value to clinical teams.

Experience

1. Clinical Research Associate

   Insignia Communications Pvt. Ltd

   Jul 2024 — Present · Mumbai, IN

Education

• Bhartiya Vidya Bhavans Sardar Patel Institute of Technology Munshi Nagar Andheri Mumbai

  Bachelor of Science - BS, Biotechnology

• Jehangir hospital clinical development center

  Diploma of Education, Clinical Research

• Ramnarain Ruia College - Mumbai

  Master's degree, Biotechnology

  2018 — 2020