Karnika y M
Project Coordinator @Micro Therapeutic Research Labs Private Limited
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WORK HISTORY
Project Coordinator @Micro Therapeutic Research Labs Private Limited
Coordinate cross-functional execution of Phase I BA/BE and healthy volunteer studies from initiation through close-out• Act as a single-point operational contact between Sponsors/Clients and MTR for assigned studies• Coordinate with Heads of Departments and functional teams to track study status, timelines, and deliverables• Monitor study progress against committed timelines; proactively flag risks related to schedule, quality, or compliance to management• Drive timely study completion through structured follow-ups, dependency tracking, and issue escalation• Support EC submissions, responses, and approval tracking in compliance with CDSCO requirements• Contribute to TMF oversight, essential document reconciliation, and inspection-readiness activities• Maintain controlled records of sponsor communications, client feedback, and study-level correspondence• Prepare internal study status updates, deviation trackers, and management reports
EDUCATION
SRM Institute of Science and Technology (SRMIST)
Bachelor of Technology - BTech, Biotechnology
ABOUT KARNIKA Y M
I am a biotechnology graduate with a strong specialization in molecular biology and translational proteomics, with focused experience in exosome-based biomarker research for gastric cancer. Over the course of my academic training and research internships, I have gained substantial hands-on exposure to advanced analytical workflows including ultracentrifugation, SEM/TEM imaging, exosome particle profiling, SDS-PAGE, ELISA, MALDI-TOF and MTT assay-driven cytotoxicity evaluation.My academic work has centered on discovering novel serum- and exosome-derived protein markers for early cancer detection, while maintaining rigorous documentation standards, reproducibility, and data integrity. These projects allowed me to integrate wet-lab execution with research reporting, technical SOP-building and collaborative investigation.Currently, I serve in a Phase-I Clinical Medical Writing role, where I contribute to protocol development (healthy volunteer studies), synopses, ICFs, CRFs, and study annexures, while ensuring ICH-GCP and CDSCO guideline alignment. I collaborate cross-functionally with Clinical Operations, QA, regulatory and scientific teams to ensure scientific justification, feasibility and compliance in early-phase studies.I aim to build a career at the intersection of biomedical innovation, regulated research, and analytical science, with interest in IVD development, biomarker discovery, quality systems, translational oncology research, and clinical documentation.
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