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Click here or scroll down to respond to this candidateCandidate's Name EMAIL AVAILABLE LinkedInWest Palm Beach, FL Street Address PHONE NUMBER AVAILABLEClinical Research AssociateCertified, seasoned professional with extensive experience in executing and managing complex clinical trials across diverse therapeutic areas.Skilled in implementing robust protocols, ensuring regulatory compliance, and driving projects to successful completion within stringent timelines. Instrumental in site management, performance monitoring, and issue resolution to guarantee data integrity and trial quality. Exceptional problem-solving skills coupled with keen eye for detail, consistently contributing to seamless execution of clinical research processes. Committed to fostering collaborative relationships with cross-functional teams, sponsors, and investigative sites to achieve optimal trial outcomes. Dedicated individual with reputation for delivering high-quality results in fast-paced, high-stakes environments. Areas of Expertise Clinical Trial Management Site Initiation & Closeout Training & Development Project Planning & Execution Electronic Data Capture Systems FDA Compliance & GCP Guidelines Investigator & Vendor Oversight Site Relationship Management Quality Control & Assurance Research Protocol Adherence Data Monitoring & Reporting Continuous ImprovementAccomplishments Crafted and executed comprehensive SOPs and Investigations Manual, leading to successful ISO certification in 2021. Transformed messy trials into high-quality data, earning approval from both monitors and sponsors through meticulous cleanup and updates.Career ExperienceSite Manager, Care Access, Delray Beach, FL. 2022 Present Manage and lead three to four CRCs on-site, fostering collaborative and efficient work environment. Review and QC data on EDC platforms and source documents for accuracy and compliance. Arrange and revise studies, support audits, and uphold organized site. Drove successful application of clinical trials, confirming seamless oversight. Deployed company SOPs and provided comprehensive training to team. Met with vendors, approved work orders, and ensured prompt approval of invoices. Coordinated with QA to develop and implement strategies for excellent report delivery. Clinical Research Coordinator, Metabolic Research Institute, West Palm Beach, FL 2021 2022 Updated study documentation in alignment with protocol guidelines and sponsor specifications, certifying comprehensive and accurate records. Collaborated closely with Clinical Research Associates (CRAs), delivering valuable support and maintaining effective communication channels. Cooperated and oversaw execution of 6 clinical trials at various phases, guaranteeing seamless operations and adherence to protocols.CRC & Team Lead, Centro Medico Julian Coronel, Cali, Colombia, S.A. 2013 2021 Revised case reports and source documents for clinical trials, while orchestrating study interviews and spearheading recruitment efforts. Maintained meticulous records, confirming accurate information on protocols and case reports, and developed comprehensive flow sheets to identify subject eligibility. Effected rigorous QA/QC procedures, sustained worksheets and study materials, and proficiently collected data while efficiently ordering necessary supplies. Prepared consent amendments and processed specimens with precision, representing keen attention to detail and adherence to research protocols. Organized sponsor files adeptly to enable FDA compliance and adherence to GCP guidelines, playing pivotal role in overall success of clinical research initiatives. EducationBachelor of Arts in Psychology, 2009Florida Atlantic University, Boca Raton, FL.CertificationAssociation of Clinical Research Professionals Certification- Certified Professional Oct 2023 Association of Clinical Research Professionals |
