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About Candidate
I am a Research Associate with a Master’s degree in Pharmaceutical Economics and Policy and hands-on experience supporting clinical research studies. I have strong skills in data collection, regulatory documentation, study coordination, and adherence to ICH-GCP guidelines. I am highly detail-oriented, organized, and dependable, with the ability to manage multiple research tasks, collaborate with cross-functional teams, and support investigators in ensuring high-quality, compliant research execution. I am driven to contribute accurate, reliable research that supports evidence-based decision-making and advances patient care.
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Work & Experience
- Coordinated clinical trials across feasibility, screening, enrollment, follow-up, and close-out in compliance with ICH-GCP and FDA regulations. - Conducted patient pre-screening and screening using EHR (eClinicalWorks), eligibility criteria, and medical record review. - Managed informed consent, source documentation, regulatory binders, and study logs. - Supported study start-up, monitoring visits, and sponsor/CRO communication. - Performed EDC data entry, query resolution, and adverse event documentation.
