Kanchipuram, Tamil Nadu, India
Clinical Research Coordinator with hands-on experience managing oncology clinical trials across Lung Cancer at Leszarians Company. M.Pharm (Pharmacognosy) graduate with a strong foundation in pharmaceutical sciences, ICH-GCP guidelines, and clinical trial operations. Currently coordinating Phase II/III trials, ensuring protocol adherence, patient safety, and data integrity. Skilled in patient recruitment, informed consent, adverse event reporting (AE/SAE), EDC systems, and Trial Master File (TMF/ISF) maintenance. Passionate about contributing to drug development in oncology and committed to advancing clinical research with precision, ethics, and patient-centric care. Core Competencies: · Oncology Trials (Lung, Colorectal, Breast Cancer) · ICH-GCP & Regulatory Compliance · Patient Screening & Informed Consent · Adverse Event (AE/SAE) Monitoring · EDC & · Source Data Verification (SDV) · TMF / ISF Maintenance · RECIST Criteria & Tumor Assessments Helping beginners understand practical clinical research workflows. DM for mentorship/interview preparation. https://topmate.io/sathiya_moorthi11/
Quality Control & Compliance: Performed in-process quality tests (friability, hardness, disintegration) ensuring adherence to SOPs and regulatory standards. Documentation: Maintained 5+ daily Batch Manufacturing Records (BMRs), emphasizing accuracy and audit readiness. Process Optimization: Monitored tablet compression and coating processes, ensuring consistency and compliance with quality parameters.