Clinical Research Associate
Resume:
Michael Sawyer
Davenport FL *****
Summary
Highly skilled and experienced clinical research professional with over 15 years of experience in the pharmaceutical and healthcare industries. Proven ability to manage all aspects of clinical trials, from study design and initiation to data analysis and reporting. Strong understanding of regulatory requirements and ICH guidelines. Excellent communication, interpersonal, and organizational skills. Seeking a challenging opportunity in the insurance industry where I can leverage my clinical research expertise and contribute to the success of the company.
Skills
Clinical Research: Study design, initiation, monitoring, data analysis, reporting, regulatory compliance, ICH guidelines
Project Management: Budget management, timelines, resource allocation, risk assessment, communication
Data Management: CRF completion, data entry, database management, data analysis, reporting
Regulatory Affairs: IRB submissions, INDs, IDEs, safety reporting, adverse events
Communication: Written and verbal communication, interpersonal skills, conflict resolution
Organizational Skills: Time management, attention to detail, multi-tasking, problem-solving
Experience
Life Changing Research LLC - Orlando, FL Contract Senior Clinical Research Associate November 2023 - Present
Managed all aspects of multiple clinical trials, from study design and initiation to data analysis and reporting
Ensured compliance with regulatory requirements and ICH guidelines
Developed and implemented training programs for clinical research sites
Provided ongoing support and guidance to clinical research sites
Prepared and submitted essential document packages required for clinical site initiation
Reviewed and managed data on site and remotely; resolved issues on continuous basis to achieve timely database lock targets
Professional Experience (Selected Highlights)
United BioSource Corporation - Kansas City, MO Senior Clinical Research Associate July 2019 - September 2020
Consistently completed on-site monitoring in accordance with project-specific timelines
Ensured timely completion of site monitoring reports, confirmation/follow-up letters
Assisted PM and management team by being an AIM leader
Covance (previously Chiltern) - Princeton, NJ Sr. Clinical Research Associate January 2017 - July 2019
Monitored clinical trials for the execution of clinical research projects
Prepared and submitted essential document packages required for clinical site initiation
Collaborated with the CTM/PM to ensure study milestones are met
Reviewed and managed data on site and remotely
Chiltern International - Cary, NC Clinical Research Associate II April 2015 - January 2017
Conducted all site visits including qualification, initiation, monitoring, motivational, audit support, and closeout visits
Ensured investigator site files are assembled appropriately and required documentation is in place
Proactive communication with study sites
Tracked patient recruitment and discussed potential risks and opportunities with the Project Manager
Prepared and conducted all site visits including qualification, initiation, monitoring, motivational, audit support, and closeout visits
Additional Experience
University of Miami - Clinical Research Monitor (Contract)
Florida Center for Gastroenterology - Clinical Research Coordinator
Florida Hospital - Pepin Heart Institute - Clinical Research Associate
Enzon Pharmaceuticals - Clinical Research Associate
Education
MS Information Technology
BS Health Care Services
Resident Insurance License 0620 - ADJUSTER - ALL LINES
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