Clinical Research Associate
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CCRP-SOCRA with 5+ years of experience managing clinical trials, vaccine research, and epidemiology studies. I specialize in end-to-end trial execution, ensuring compliance with ICH-GCP, FDA, and local regulations while maintaining data integrity, patient safety, and protocol adherence.
My expertise includes study start-up through close-out, IRB/EC submissions, protocol amendments, SAE/AE reporting, site training, monitoring, and audit-ready documentation. I am proficient in clinical systems (iMedidata, REDCap, TRIALMAX, CTMS) and skilled in IP management, workflow optimization, and cross-functional collaboration.
Recognized for streamlining operations, mitigating compliance risks, and accelerating site activation, I bring both technical depth and strategic insight to clinical research. I am expanding my expertise in clinical development strategy, protocol design, and post-market oversight to contribute to impactful healthcare innovation.
Rohit Godiya is a SOCRA-certified Clinical Research Professional with 5+ years of progressive experience in global clinical research operations, spanning Nepal, South Korea, and the United States. He brings deep expertise across Phase III clinical trials, with a strong focus on vaccines, infectious diseases, pediatrics, epidemiology, and medical devices.
He has held roles as a Clinical Research Coordinator, Clinical Research Associate, Senior CRA, and Clinical Operations Consultant, managing the full clinical trial lifecycle—from study feasibility and site start-up through close-out. His experience includes IRB/EC submissions, regulatory compliance, informed consent, patient recruitment, site management, monitoring (SIV/IMV/COV), SDV, safety reporting (AE/SAE), protocol deviations, CAPA implementation, and audit readiness.
Rohit has led and supported multiple large-scale international trials, including Phase III vaccine studies (COVID-19, RSV, cholera, typhoid) and surveillance studies, serving as a key operational link between sponsors, CROs, investigators, and sites. He is highly experienced in eTMF/ISF oversight, IP accountability, enrollment tracking, data quality control, and cross-functional coordination.
He is proficient with leading clinical systems and tools including Medidata Rave, iMedidata, REDCap, CTMS, TrialMaster, RTSM/IRT, SQL, SPSS, and R, and is well-versed in ICH-GCP, FDA 21 CFR, HIPAA, and ISO standards. Known for his process-driven mindset, Rohit builds structured trackers, quality frameworks, and operational workflows to ensure compliance, efficiency, and data integrity.
Currently based in the United States, Rohit is pursuing an MS in Applied Clinical Research (MedTech focus) while serving in academic and leadership roles. He is driven by a strong commitment to patient safety, operational excellence, and continuous learning, with career goals aligned toward Clinical Trial Project Management, Clinical Operations, and senior CRA leadership roles.
Rohit Godiya is currently pursuing a Master of Science in Applied Clinical Research (MedTech focus) at St.
University, Minnesota, where his training emphasizes clinical trial design, regulatory compliance, medical device research, quality systems, and evidence-based research practices. His coursework integrates real-world application across study start-up, IRB submissions, monitoring, risk management, data integrity, and regulatory documentation, preparing him for sponsor-, CRO-, and site-level clinical operations roles.
He holds a Bachelor of Pharmacy (BPharm) from Jawaharlal Nehru Technological University (JNTU), Hyderabad, India, which provided a strong foundation in clinical pharmacology, therapeutics, drug safety, biostatistics, and patient-centered care. This background supports his expertise in investigational product management, safety reporting, protocol compliance, and clinical decision-making across vaccine and device trials.
Complementing his formal education, Rohit is a SOCRA-Certified Clinical Research Professional (CCRP) and has completed extensive GCP and regulatory training, reinforcing his ability to operate within ICH-GCP, FDA 21 CFR, HIPAA, and ISO-aligned research environments.
