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Candidate's Name
Fort Myers, FLCell Phone: PHONE NUMBER AVAILABLE LinkedIn LINKEDIN LINK AVAILABLE Email: EMAIL AVAILABLECLINICAL RESEARCH COORDINATORDedicated and experienced Research Coordinator with a strong commitment to Good Clinical Practice (GCP) principles. Proficient in-patient recruitment, protocol management, laboratory oversight, and study completion management. Passionate about ensuring comprehensive adherence to research protocols from site initiation to closeout.CORE COMPETENCIESGCP CertificationElectronic Data CaptureMicrosoft Outlook and Excel EfficientRegulatory ReportingALCOA DocumentationCritical ThinkingData AnalysisIRB Reporting/DocumentationInvestigational Product AccountabilityMedical Device InventoryIATA CertifiedDetail OrientedHigh Volume EnrollmentEDUCATIONBachelor of Arts & Sciences in Integrated StudiesPublic Health, Florida Gulf Coast University Fort Myers, FLPROFESSIONAL EXPERIENCEAlliance for Multispecialty Research, Fort Myers, FL June 2021 CurrentClinical Research Coordinator (January 2023 to Current)Clinical Research Coordinator Assistant (June 2021 - December 2022)Ensure adherence to GCP guidelines for on-site and virtual patient visits across 10-12 active Phase II-IV trials.Proficient in various EDC, IRT, IWRS, and laboratory systems.Led initiative to redesign shipping and tracking system, enhancing efficiency for over 250 patients and 12 studies.Collaborate with stakeholders to establish effective communication channels for clinical trial patients.Communicate study goals and compliance importance to patients during pre-screening and screening visits.Review medical records and medications for inclusion/exclusion criteria adherence.Manage and report Serious Adverse Events within 24 hours, ensuring proper documentation and follow-up.Assist regulatory team in protocol deviation documentation and IRB reporting.Quality Assurance Specialist (January 2022 - December 2022)Review source documentation versus CRFs for up to 12 active studies.Coordinate CRA visits and facilitate communication with stakeholders.Conduct SOP reviews and recommend revisions as needed.Manage Site Operational Procedures and regulatory tasks.VOLUNTEER EXPERIENCEKappa Delta Sorority President November 2019 - November 2020Led chapter operations for 120 members, overseeing philanthropy events and financial affairs.Managed executive council and maintained communication with Nationals.Represented the sorority at university meetings and facilitated workshops on diversity and inclusion.SKILLSMicrosoft Office Suite: Word, Excel, PowerPoint, and OutlookData Analysis: Familiarity with data analysis tools including, Microsoft Excel (including formulas, functions, and pivot tables), and Google Sheets