Alyssa Baptista
Palmetto
Summary
Adept Clinical Research Associate with a proven track record at Jaeb Center for Health Research, ensuring high-quality data integrity and compliance with FDA guidelines. Expert in electronic data capture and site management, I excel in proactive risk management and effective stakeholder communication, significantly enhancing study outcomes. Certified in Good Clinical Practice, my detailed documentation skill complements my results-driven approach.
Overview
17
17
years of professional experience
Work History
Clinical Research Associate
Jaeb Center for Health Research
07.2007 - Current
- Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion per FDA guidelines.
- Assisted clinical sites in preparation for study initiation.
- Conducted monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Implemented electronic data capturing systems to adhere with clinical research guidelines.
- Enhanced data quality by closely monitoring study progress and ensuring accurate data collection.
- Supported the successful completion of clinical trials by proactively managing risks and addressing challenges throughout all stages of the study process.
- Facilitated timely resolution of issues through effective communication with investigators, sponsors, and other stakeholders.
Education
Bachelor of Science - Public Health
University of South Florida
Tampa, FL08.2011
Skills
- Certified Clinical Research Professional (CCRP)
- Knowledge of medical terminology
- Site Management
- Detailed documentation
- Electronic Data Capture
- ICH Guidelines
- Informed Consent Process
- Adverse event reporting
- Source Document Verification
- Good Clinical practice (GCP)
Timeline
Clinical Research Associate
Jaeb Center for Health Research
07.2007 - Current
Bachelor of Science - Public Health
University of South Florida
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