About
Clinical Research Coordinator with 2 years 7 months of hands-on experience managing clinical trials from site initiation through closeout, across Orthopaedics, Gastroenterology, and Neurology. I currently work at SMO Clinical Research (India) Pvt. Ltd, where I manage a portfolio of Phase I, II, and III trials, coordinate Ethics Committee submissions end-to-end, and oversee regulatory filings with CDSCO, CTRI, and DHR. Recent wins include a new CRO registration approval, two Ethics Committee re-registrations, and provisional DHR approvals for two hospital sites — all achieved with a 100% approval rate. Beyond my own sites, I review trial progress at other CRO sites and train their study coordinators on documentation, patient recruitment, and archival practices — work that's given me real exposure to multi-site oversight. What I bring: 📋 GCP/ICH-compliant trial coordination and source documentation ⚖️ Ethics Committee & regulatory submissions (CDSCO, CTRI, DHR, IRB/EC) 💻 EDC systems — Medidata RAVE, Oracle Clinical 🎯 Patient recruitment, retention, and AE/SAE reporting 👥 Training and mentoring junior site staff I'm GCP trained and hold ISEP certification in Clinical Research, Pharmacovigilance, Clinical Data Management, Regulatory Affairs, and Medical Writing. I'm now looking to grow into a Clinical Research Associate or Site Specialist role, where I can bring this site-level depth and regulatory track record to a broader portfolio of studies. Open to connecting with fellow clinical research professionals, recruiters, and anyone working to get safe, effective treatments to patients faster. 📧 jeevankalyan91@gmail.com
Work experience
Clinical Research Coordinator at SMO Clinical Research Private Limited, May 2024 - Present · 2 yrs 7 mos
Clinical research coordinator at SMO Clinical Research Private Limited, Feb 2024 - Present · 2 y 9 mo, 261,15 th main, RMV extension, Sadashiva nagar, Bangalore
Clinical Research Coordinator at SMO Clinical Research Private Limited, Feb 2024 - Apr 2024 · 3 mos
Education
Diploma of Education, Clinical Research, Clinical Data Management, Pharmacovigilance, Regulatory affairs, xcelcareer
B Pharmacy, Pharmacy, institute of management
