Clinical Research Associate

ABIGAIL YOMI

Cypress, TX **************@*****.*** 832-***-****

PROFESSIONAL SUMMARY

Dedicated Clinical Research Associate with extensive experience in oncology and neurology clinical trials. Skilled in site monitoring, regulatory compliance, and patient advocacy. Proven expertise in managing complex Phase I–III trials, ensuring data integrity, and maintaining adherence to GCP and FDA standards. Adept at fostering collaborative relationships with investigators, sponsors, and site teams to achieve trial objectives efficiently and ethically. EDUCATION

Bachelor of Science in Health Sciences

Arizona State University – Phoenix, AZ

Associate of Science in Health and Medical Sciences Houston Community College – Houston, TX

PROFESSIONAL EXPERIENCE

MD Anderson (Hybrid)

Clinical Research Associate I

04/2022 – Present

● Monitored study progress across multiple sites, conducting source document verification, protocol adherence checks, and study drug accountability during on-site visits every 4-6 weeks.

● Traveled extensively to assigned clinical trial sites, performing initiation, interim, and close-out visits while assessing site readiness for patient enrollment and verifying compliance with trial protocols.

● Ensured all clinical activities complied with GCP, ICH guidelines, and applicable local and international regulations.

● Reviewed source documentation against electronic case report forms (eCRFs) to verify trial data accuracy, completeness, and consistency.

● Monitored and ensured the proper reporting of adverse events (AEs) and serious adverse events (SAEs).

● Provided hands-on training to investigators and site staff on study protocols and procedures.

● Ensured proper handling, storage, and documentation of investigational products.

● Developed action plans to resolve site challenges and maintain trial timelines.

● Established strong working relationships with site investigators, study coordinators, and CRO project teams.

● Prepared comprehensive monitoring reports, follow-up letters, and documentation of site visit findings.

University of Texas Medical Branch (UTMB) – Hybrid Clinical Research Coordinator II

05/2020 – 03/2022

● Monitored study progress across multiple sites, ensuring compliance with trial protocols and regulatory requirements.

● Oversaw patient enrollment, informed consent processes, and study progress.

● Prepared detailed site visit reports with a draft completion timeline of 5 business days.

● Utilized systems like Data-Labs, Inform, Trial-Master, and Medidata for data entry and analysis.

● Coordinated patient care and ensured adherence to study requirements.

● Maintained accurate regulatory documentation, collaborating with investigators to ensure IRB compliance.

● Contributed to revising clinical SOPs and monitoring strategies. University of Texas Medical Branch (UTMB) – Galveston, TX Clinical Research Coordinator I

08/2019 – 04/2020

● Collaborated with site personnel and sponsors on study selection, startup, and ongoing trial management.

● Conducted regular site visits to verify source documentation, monitor study drug storage, and review regulatory files.

● Addressed quality improvement opportunities, implementing action plans for trial performance enhancement.

● Ensured timely, accurate data collection and adherence to trial requirements.

● Trained site staff on clinical trial processes and regulatory compliance. University of Texas Medical Branch (UTMB) – Galveston, TX Clinical Research Coordinator

01/2018 – 01/2019

● Maintained accuracy in trial documentation and promptly resolved site-level issues.

● Oversaw up to 20 sites and managed three protocols concurrently.

● Participated in audits, ensuring regulatory compliance.

● Coordinated patient care in compliance with protocol requirements. THERAPEUTIC EXPERTISE

Oncology Neurology Infectious Diseases

KEY SKILLS

● Site Monitoring & Management

● Clinical Trial Oversight (Phases I-III)

● FDA & ICH GCP Compliance

● Patient Advocacy & Informed Consent

● Regulatory Documentation (IRB, 1572s, CVs)

● Data Integrity & Source Document Verification

● eTMF Systems: Veeva Vault, Impact, e-Clinical

● EDC Platforms: Medidata, Data-Labs, Trial-Master

● Strong Communication & Time Management

CERTIFICATIONS & TRAININGS

● Advanced Clinical Research Associate Certification (ACRAC) – The Accreditation Council for Clinical Research Education (ACCRE)

● Additional Training: Good Clinical Practice (GCP), FDA regulatory compliance, eTMF utilization, EPIC, Athenahealth

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