Chelsie Marie Caruso
Clinical Research Associate @Biorasi
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WORK HISTORY
Clinical Research Associate @Biorasi
Schedule, Plan and Conduct Site Visits: Site Selection Visits, Site Initiation Visits, Interim Monitoring Visits and Site Close-out Visits. • Write Reports and Investigator Follow-up Letters for Site Visits: Site Selection Visits, Site Initiation Visits, Interim Monitoring Visits and Site Close-out Visits. • Manages the progress of assigned studies by tracking regulatory/ IRB submissions and approvals, recruitment, and enrolment, CRF completion and submission, and data query generation and resolution • Provide project updates to project management team. • Organize delivery of investigational product, laboratory supplies, CRFs and other study specific materials to and from the clinical sites. • Perform investigational product inventory, ensuring return of unused investigational product to designated location or verifies destruction as required. • Assists with, and attends, Investigator Meetings for assigned studies. • Review study documents for compliance with protocol, ICH GCP guidelines, Protocol Deviations/Violations and Waivers, review study documents for subject safety events; escalate Issues at site to project management. • Collect and review essential study documents from site for filing in eTMF. • Administer protocol and study related training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues. • Evaluate quality and integrity of study site practices related to the proper study conduct, ensuring adherence to applicable regulations. • Compliances: Follow international GCP guidelines/regulations and SOPs for executing clinical studies. Participates in the planning of quality assurance activities and coordinates resolution of audit findings. • Assist, as appropriate, with reporting site performance regarding timelines and deliverables to the project team during team meetings and assist with providing feedback for analysis of overall study performance.
EDUCATION
California State University, Monterey Bay
Health Science, Kinesiology
California State University, Monterey Bay
Kinesiology and Exercise Science
Clinical Research Fastrack
Certfied Clinical Coordinator, Clinical Research
Arizona State University
Masters Degree, Clinical Research Management, 4.0
Alfred State College - SUNY College of Technology
Associate of Arts and Sciences (A.A.S.)
ABOUT CHELSIE MARIE CARUSO
I am a Clinical Research Associate at Biorasi, a global clinical research organization that delivers innovative solutions for clinical trials. I have a Master\'s degree in Clinical Research Management from Arizona State University, where I gained a solid foundation in the principles and practices of clinical research. My core competencies include regulatory operations, good clinical practice (GCP), and clinical trial management. In my current role, I am responsible for planning, conducting, and reporting site visits, tracking study progress, providing project updates, and organizing delivery of study materials. I collaborate with project managers, site personnel, investigators, and vendors to ensure the quality and integrity of the data and the safety and protection of the study participants. I am motivated by the opportunity to contribute to the advancement of medical science and the improvement of patient outcomes. I bring diverse perspectives and experiences to the team, as I have worked in various settings and roles in the healthcare and research sectors, such as nursing, telemetry, and oncology, autoimmune disease, infectious disease, device and hepatitis, and have worked on phase I-IV studies. I am passionate about learning new skills and staying updated on the latest developments in the field.
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