Clinical Research Data Verification
Resume:
Saul Vera, MD
Chula Vista, CA *****
**************@*****.***
Professional Summary
Detail-oriented Medical Doctor and Clinical Research Professional with over 7 years of experience in Phase 1-3 clinical trials, specializing in vaccine research (COVID-19, RSV, Influenza). Skilled in site management, patient safety monitoring, and regulatory compliance with ICH-GCP, FDA, and IRB standards. Proven track record coordinating complex studies, performing source data verification, and collaborating with sponsors and CROs. Proficient in EDC systems (Medidata Rave, InForm), adverse event reporting, and data quality control. Fluent in English and Spanish, with strong communication and team leadership abilities, seeking to leverage expertise as a Clinical Research Associate. Key Skills
● Clinical Trial Monitoring & Site Management
● Source Data Verification (SDV) & Quality Assurance
● Regulatory Compliance (ICH-GCP, 21 CFR Part 11, FDA, IRB/IEC)
● Electronic Data Capture (EDC: Medidata Rave, InForm)
● Adverse Event (AE) & Serious Adverse Event (SAE) Reporting
● Patient Recruitment, Screening & Informed Consent
● Sponsor & CRO Collaboration
● Protocol Implementation & Query Resolution
● Vaccine Trials & Infectious Disease Research
● Data Analysis & Medical Record Review
Professional Experience
Clinical Research Sub Investigator
California Research Foundation, Kearny Mesa, CA
July 2021 – Present
● Serve as Sub-Investigator for Phase 1-3 vaccine trials (COVID-19, RSV, Influenza), overseeing 500+ participants across 10+ protocols.
● Conduct clinical assessments, monitor patient safety, and perform source data verification to ensure data integrity and protocol adherence.
● Collaborate with sponsors and CROs during site visits, addressing queries and ensuring compliance with ICH-GCP and FDA regulations.
● Administer investigational products, track adverse events (AEs/SAEs), and report findings to IRBs, achieving 100% reporting accuracy.
● Educate and consent participants, streamlining enrollment by 20% through clear protocol explanations.
● Maintain trial master files (TMF) and EDC entries (Medidata Rave), supporting audit readiness.
Clinical Research Coordinator
WCG/Threewire, San Diego, CA
July 2021 – December 2023
● Managed site operations for COVID-19 vaccine trials, enrolling 750+ patients across 5 studies within 6 months.
● Performed source data verification and resolved 200+ protocol queries, ensuring 98% data accuracy in EDC systems (InForm).
● Coordinated with study monitors and sponsors during 15+ site visits, facilitating regulatory inspections and corrective actions.
● Led informed consent processes and patient visits, reducing dropout rates by 15% through proactive engagement.
● Documented AEs/SAEs per GCP standards, contributing to successful study closeouts with zero major findings.
MD / Surgical Assistant
Oasis of Hope Hospital, Tijuana, Mexico
January 2021 – July 2021
● Assisted in 50+ laparoscopic surgeries, ensuring patient safety and post-operative care compliance.
● Managed medical records and STAT orders, improving wound healing evaluation turnaround by 25%.
● Communicated procedures to patients in English and Spanish, enhancing informed consent comprehension.
Clinical Research Coordinator / Clinic Manager
Dorrington Medical Associates, Houston, TX
December 2019 – January 2021
● Coordinated COPD and asthma trials, managing 300+ patients and ensuring 100% GCP compliance.
● Conducted spirometry, sample collections, and EDC data entry (Medidata), supporting site audits with zero discrepancies.
● Supervised 5 CRCs and MAs, optimizing clinic workflows and reducing data entry errors by 30%.
Education
Medical Doctor (MD)
UABC, Tijuana, Mexico
August 2014 – December 2019
Certifications
● Advanced Cardiovascular Life Support (ACLS) – AHA
● Responsible Conduct of Research – CITI Program
● Good Clinical Practice (GCP) for Clinical Trials Involving Investigational Medical Devices – CITI Program
● Human Research, Biomedical Researchers – CITI Program
● MD License – Mexico
Clinical Research Protocols (as Sub-Investigator)
● Phase 3 RSV vaccine efficacy and safety (Adults, 2022-2024)
● Phase 1-3 COVID-19 RNA vaccines (e.g., BNT162b2, 2021-2023)
● Phase 2-3 Influenza and combo COVID-19/Influenza vaccines (2022-2024)
● Phase 2-3 Dengue vaccine immunogenicity (2023)
Publications
● Chukwudum, C.A., Vera, S., Sharma, M., Varon, J., Surani, S., “Heyde Syndrome: A Case Report and Literature Review,” Cureus, April 30, 2020. Languages
● English: Fluent
● Spanish: Fluent
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