Profile Details

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Hire Renya M.

United States

USD 50 /hr

Regulatory Analyst with proven expertise in IRB submissions and compliance, binder QA/QI, and site start up processes

Profile Summary

Regulatory Analyst with proven expertise in IRB submissions and compliance oversight, binder QA/QI, FDA inspection preparation, regulatory documentation, and clinical research operations. MPH and CPH-certified with experience supporting over 60 clinical trials, including phase I – IV drug and device studies, and investigator-initiated trials (IITs). Highly effective in cross-functional team settings, facilitating smoother feasibility and start-up process.

Subject Matter Expertise

• ☆ Clinical Trials
• ☆ IRB Applications
• ☆ Clinical Trial Design
• ☆ Clinical Trial Site Selection & Monitoring
• ☆ Regulatory Affairs
• ☆ Regulatory Writing
• ☆ Clinical Trial Documentation
• ☆ Clinical Trial Protocol Writing
• ☆ Technical & Scientific Writing
• ☆ Experimental Protocols
• ☆ SOP & Protocol Writing

Services

• Writing

Writing Clinical Trial Documentation, Medical Writing, Non-Medical Regulatory Writing, Technical Writing, Business & Legal Writing, Copywriting, Creative Writing

Work Experience

Regulatory analyst

Tampa General Hospital

January 2023 - Present

Executive Assistant

Tampa General Hospital

April 2021 - January 2023

Education

Master of Public Health

University of South Florida

August 2021 - December 2024

Certifications

• Certification details not provided.

Publications

JOURNAL ARTICLE

Licong Zhao, Heather Agazzi, Yasong Du, Hongdao Meng, Renya Maku, Ke Li, Peter Aspinall, Cynthia Wilson Garvan, Shuanfeng Fang (2024). A Digital Cognitive-Physical Intervention for Attention-Deficit/Hyperactivity Disorder: Randomized Controlled Trial . Journal of Medical Internet Research.

PREPRINT

Licong Zhao, Heather Agazzi, Yasong Du, Hongdao Meng, Renya Maku, Ke Li, Peter Aspinall, Cynthia Wilson Garvan, Shuanfeng Fang (2023). A Digital Cognitive-Physical Intervention for Attention-Deficit/Hyperactivity Disorder: Randomized Controlled Trial (Preprint) .