SHAKIRAT AKINDE-LOUIS
Houston,USA
Summary
Detail-oriented Clinical Research Associate with over 7 years in clinical operations and data management. Executes protocol compliance checks and safeguards patient safety in multi-site trials. Analyzes site performance and implements corrective actions, leveraging SQL and Power BI to enhance data quality and trial efficiency.
Overview
1
1
Certification
14
14
years of professional experience
Work History
CLINICAL RESEARCH ASSOCIATE
Laboratory Corporation of America
11.2021 - Current
- Compiled monthly site performance reports for sponsors, showcasing enrollment trends and identifying protocol deviations
- Conducted site evaluations to ensure compliance with regulatory requirements and study protocols.
- Developed and maintained strong relationships with clinical trial sites for seamless communication and collaboration.
- Reviewed informed consent documentation at study sites, identified discrepancies, and prompted sponsor corrections
- Prepared monitoring visit reports detailing findings and corrective action plans to ensure regulatory compliance
- Compiled monthly site performance reports for sponsors, highlighting enrollment trends and protocol deviations
- Compiled monthly site performance metrics for sponsors, highlighting enrollment trends and deviation patterns
- Documented and monitored investigational product receipts to ensure accurate inventory management and reconciled clinic pharmacy logs to resolve inventory discrepancies promptly
- Monitored patient safety across seven trial sites, logged adverse events in EDC within 48 hours
- Performed source-data verification across EPIC and EDC, closed protocol queries and enhanced data accuracy
- Monitored patient recruitment and retention strategies to optimize trial enrollment timelines.
- Collected and tracked investigational product accountability records, reconciling inventory differences with pharmacy logs
- Tracked investigational product receipts and reconciled clinic pharmacy logs to resolve inventory discrepancies promptly
- Trained site coordinators on EDC entry standards and query responses to improve data completeness
DATA ANALYST
Laboratory Corporation of America
12.2013 - 11.2021
- Built Power BI reports and SQL queries that revealed operational trends, informing leadership decisions
- Collaborated with stakeholders to define reporting requirements and delivered dashboards that enhanced operational team insights
- Authored SQL rules and scripts to extract and filter data, correcting discrepancies and improving data quality
- Analyzed assay throughput with SQL to identify bottlenecks and reduce processing delays
- Cleaned and validated clinical trial datasets in Excel to resolve inconsistent entries and improve accuracy
- Cleaned and validated clinical trial datasets in Excel, resolving inconsistent entries and increasing data accuracy for analysis
PROJECT MANAGER – CANCER GENETICS LABORATORY
Baylor College of Medicine
05.2012 - 12.2013
- Coordinated clinical trial and diagnostic testing workflows to maintain on-time lab deliverables
- Managed HIPAA-compliant medical records and CRM data to ensure regulatory and data integrity
- Enhanced communication among lab staff, physicians, and genetic counselors regarding specimen status and results
- Improved communication between lab staff, physicians, and genetic counselors about specimen status and results
- Prepared weekly trial-status dashboards in Excel for stakeholders to support timely decisions
- Developed weekly trial-status dashboards in Excel for stakeholders to facilitate timely decision-making
- Recorded protocol deviations and reported to IRB to ensure regulatory compliance
Education
MASTER OF SCIENCE - CLINICAL PRACTICE MANAGEMENT
Texas Tech University Health Sciences Center
Houston, USA08-2015
BACHELOR OF SCIENCE - CYTOGENETICS
University of Texas MD Anderson Cancer Center
Houston, USA08-2010
Skills
- Electronic Data Capture, SQL, Power BI, Advanced Excel, EPIC, AWS, Microsoft Office Suite, Process Improvement, Quality Assurance, Clinical Trial Design, Patient Recruitment, Protocol Development, Data Management, Statistical Analysis, Clinical Monitoring, Regulatory Compliance, Inventory Control, Site management, Pharmacovigilance,ICH guidelines
- Site monitoring
Certification
GCP CLINICAL RESEARCH (GCP), NIDA Clinical Trials Network (CTN), ASCP CERTIFIED IN CYTOGENETICS (CG), American Society for Clinical Pathology, CERTIFIED CLOUD PRACTIONER, AMAZON WEB SERVICES, CERTIFIED: POWER BI DATA ANALYST PROFESSIONAL, Microsoft, DATABASES AND SQL FOR DATA SCIENCE, IBM
Personal Information
Title: Clinical Research Associate
Timeline
CLINICAL RESEARCH ASSOCIATE
Laboratory Corporation of America
11.2021 - Current
DATA ANALYST
Laboratory Corporation of America
12.2013 - 11.2021
PROJECT MANAGER – CANCER GENETICS LABORATORY
Baylor College of Medicine
05.2012 - 12.2013
BACHELOR OF SCIENCE - CYTOGENETICS
University of Texas MD Anderson Cancer Center
MASTER OF SCIENCE - CLINICAL PRACTICE MANAGEMENT
Texas Tech University Health Sciences Center