Deva Kumar
Clinical Research Coordinator | ICH-GCP Certified | Phase 2 & 4 Trials | Diabetes & DFU | CRC with Sponsor & CRO Liaison Experience
- Role
- Clinical Trial Associate at HCLTech
- Location
- Chennai, IN
- LinkedIn followers
- 500 followers
About Deva Kumar
I’m a Clinical Research Coordinator with hands-on experience in over 6 clinical studies…
Experience
Clinical Trial Associate
Apr 2024 — Present · Chennai, IN
Coordinated day-to-day site operations for 6 clinical trials across interventional, observational, and retrospective designs (Phase 2 and 4).Managed major trials including:• Reverse-2 Study (Phase 2 – Bacteriophage TP-102) – Sponsor: Technophage, CRO: JSS Medical Research• Lyumjev Comparative Study (Phase 4 – Insulin) – Sponsor: Eli Lilly, CRO: IQVIA• Captivate India Study (Retrospective) – MAH: Novo Nordisk, CRO: Eversana (Cliniv EDC)• Esmolol Hydrochloride Study (Phase 4 – DFU) – Sponsor: IPCAHandled full IP accountability: receiving, storing, dispensing, reconciling, and documenting investigational product usage.Performed patient screening, informed consent, and supported site staff in managing Type 1 DM and DFU cases.Maintained accurate source notes, CRFs, and visit documentation; ensured compliance with ICH-GCP and study protocols.Used multiple EDC platforms (Viedoc, Nukleus, CRFWEB, Cliniv) to enter and clean clinical data, resolve queries, and track enrollment.Coordinated with CRO monitors during site initiation and monitoring visits; responded to action items and ensured eTMF was audit-ready.
Education
National Institute of Health
Good Clinical Practice
2024 — 2027
KARPAGAM COLLEGE OF PHARMACY (Inst. Code - 225), COIMBATORE
B.pharmacy
2017 — 2022
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