Michelle Gruver, Rn, Bsn, Ms, Ccra, Lnc
About Michelle Gruver, Rn, Bsn, Ms, Ccra, Lnc
Michelle Gruver is an Unblinded Study Specialist at Bristol Myers Squibb in Durham, North Carolina, with extensive experience in clinical research and consulting roles across various organizations.
Current Role at Bristol Myers Squibb
Michelle Gruver currently serves as an Unblinded Study Specialist at Bristol Myers Squibb in Durham, North Carolina. In this role, she is involved in developing study-specific quick reference tools for Unblinded Site Monitors. She provides support for unblinded site staff and local unblinded leads, addresses system issues, and answers patient dosing questions. Additionally, she tracks and records potential and actual unblinding events, collaborates with Unblinded Site Monitors, and works with Clinical Supply Operations regarding supply issues.
Previous Experience at Peachtree BioResearch Solutions
Michelle Gruver was a Senior Clinical Research Associate at Peachtree BioResearch Solutions from 2021 to 2022, based in Atlanta, Georgia. During her 11-month tenure, she focused on clinical research operational activities and supported clinical trials to ensure compliance with regulatory requirements.
Senior Clinical Operations Consultant at Renovion, Inc.
At Renovion, Inc., Michelle Gruver worked as a Senior Clinical Operations Consultant from 2020 to 2021. Her responsibilities included managing clinical research projects and ensuring that clinical operations were conducted in accordance with established protocols and guidelines. She was based in Chapel Hill, North Carolina.
Educational Background
Michelle Gruver has a comprehensive educational background in nursing and clinical research. She obtained a BSN from the University of North Carolina at Chapel Hill, studied Clinical Research at Campbell University where she earned an MS, and achieved a Certificate in Legal Nurse Consulting from Duke University. Her education has provided her with a strong foundation in both practical nursing and clinical research methodologies.
Expertise and Skills
Michelle Gruver's expertise includes developing study-specific quick reference tools, supporting unblinded site staff, resolving system issues, and handling patient dosing questions. She also has experience tracking unblinding events, working with Clinical Supply Operations, and ensuring proper study document flow. Her skills extend to consulting on safety and dosing issues with the Medical Monitor and participating in Risk-Based Monitoring review and analysis.