Selvavaani Senthilkumar
Clinical Research Professional | Molecular Diagnostics | Regulatory Compliance | Bioinformatics | Green Card EAD Holder
- Role
- Clinical Research Trainee at Clinical Research Fastrack
- Location
- Dallas-Fort Worth, TX, US
- LinkedIn followers
- 500 followers
About Selvavaani Senthilkumar
Clinical Research Professional with 7+ years of experience in pre-clinical research, molecular diagnostics, and regulatory-compliant trials across academic and industry settings. Skilled in patient recruitment, informed consent, protocol execution, and regulatory documentation (ISF, DOA, 1572), with training in ICH-GCP and FDA 21 CFR regulations. Proficient in PCR, RFLP, SPSS analysis, and bioinformatics tools supporting lab systems and data management. Experienced in oncology, stem cell, and personalized medicine research. Currently completing Clinical Research Fastrack training with hands-on experience in quality assurance, AE reporting, and compliance. Passionate about advancing healthcare through ethical, data-driven research and innovation in clinical operations and analytics.
Experience
Clinical Research Trainee
Mar 2025 — Present · AZ, US
ICH GCP E6 R (2)FDA Regulations 21 CFR 11, 50, 54, 56 and the Common Rule 45CFR46Data ManagementInformed Consent ProcessClinical Trial Operations from feasibility through close-outGDP following ALCOA-C principlesIdentification and reporting of AEs and SAEsQuality Assurance, Monitoring, and Query ResolutionComprehension and Execution of Clinical Trial ProtocolsMaintaining a regulatory binder, housing essential documents including but not limited to 1572, DOA,Training Logs, and other Investigator Site File (ISF) document
Education
University of Greenwich
Bachelor of Science - BS
2010 — 2013
Universiti Putra Malaysia
Master of Science - MS
2016 — 2019
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