Shakira Aguilar-Oseguera
Wilmington,NC
Summary
Detail-oriented Clinical Research Coordinator with robust expertise in regulatory compliance and data management. Proven ability to ensure data integrity and support study start-up activities, contributing to timely project delivery and audit readiness.
Overview
4
4
years of professional experience
1
1
Certification
Work History
Clinical Research Coordinator II
Headlands Research TMA
Wilmington, NC
05.2023 - Current
- Perform data abstraction and entry from source documents into EDC systems including Medidata Rave, Oracle InForm, and REDCap, ensuring high accuracy and completeness
- Utilize Veeva Vault to manage regulatory documents and maintain audit-ready study files
- Review case report forms (CRFs) and study protocols to ensure proper and consistent data capture
- Identify, track, and resolve data discrepancies and queries, collaborating with investigators, sponsors, and monitors
- Conduct source data verification and quality control checks to ensure compliance with FDA and ICH/GCP standards
- Support study start-up activities , including protocol and database review, and assist with data management planning
- Serve as a liaison between clinical clinical staff and trial monitors, supportings SIVs and monitoring visits
- Ensure data integrity and timely query resolution to meet study deadlines and sponsor expectations
Clinical Research Intern
Accellacare
Wilmington, NC
09.2022 - 04.2023
- Assisted with data entry and validation using EDC systems
- Maintained accurate source documentation to support data integrity and regulatory compliance
- Supported query resolution and data cleaning efforts in collaboration with research staff
- Participated in quality assurance checks
- Maintained confidentiality of sensitive participant information while adhering to strict privacy regulations during the course of studies
Education
Bachelor of Science - Clinical Research
University of North Carolina At Wilmington
Wilmington, NC05.2023
Skills
- Regulatory Compliance: FDA regulations, ICH/GCP, SOP Adherence, source documentation
- Data Management: Data abstraction, data entry, query resolution, discrepancy management
- EDC platforms: Medidata Rave, Oracle InForm, REDCap, Veeva
- Clinical Trials: CRF reviews, protocol review, study start-up & closeout, IRB submissions
- Quality assurance: Data accuracy checks, source-to-database verification, audit readiness
- Collaboration: Liaison between monitors, Principal Investigators, and study staff
- Languages: English (Fluent) & Spanish (Fluent)
Certification
- Phlebotomy Certified - 11 June 2025
- American Heart Association, CPR Certified - 06 November 2024
Timeline
Clinical Research Coordinator II
Headlands Research TMA
05.2023 - Current
Clinical Research Intern
Accellacare
09.2022 - 04.2023
Bachelor of Science - Clinical Research
University of North Carolina At Wilmington