CRA Monitoring Specialist Outline Resume
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Professional Summary
Dedicated and detail-oriented Clinical Research Associate Monitoring Specialist with over 5 years of experience in clinical trial monitoring, site compliance, and data management. Proven expertise in adhering to GCP standards and ensuring regulatory compliance across multiple studies. Adept at building relationships with site staff and ensuring the successful execution of clinical trials.
Skills
Clinical Trial Monitoring: Site management, monitoring visits, and audit preparation.
Regulatory Compliance: Good Clinical Practice (GCP), FDA regulations, and ICH guidelines.
Data Management: Query resolution, database updates, and ensuring data integrity.
Communication: Liaising with sponsors, site staff, and cross-functional teams.
Technical Tools: EDC systems (e.g., Medidata RAVE), CTMS, and Microsoft Office Suite.
Work Experience
Senior CRA Monitoring Specialist
Global Research Organization, New York, NY
Jan 2060 – Present
Conducted over 50 site monitoring visits annually to ensure compliance with protocol and GCP standards.
Managed study timelines and resolved site-specific challenges, reducing delays by 15%.
Oversaw data collection and ensured timely query resolution during clinical trials.
Trained and mentored junior CRAs on-site management and monitoring best practices.
CRA Monitoring Specialist
Pharma Trials Inc., Boston, MA
May 2056 – Dec 2059
Monitored clinical sites for Phase II and III trials, ensuring adherence to regulatory requirements.
Conducted initiation, monitoring, and closeout visits, maintaining 98% compliance.
Collaborated with site staff to address protocol deviations and ensure corrective actions.
Prepared detailed monitoring reports for sponsors and study teams.
Education
Bachelor of Science in Biology
BioTech University, Boston, MA
Graduated: May 2055
Certifications
Additional Information
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