Grace Kranwinkel, MD, Ccrp
About Grace Kranwinkel, MD, Ccrp
Grace Kranwinkel, MD, Ccrp, is the Manager of Clinical Quality Assurance, Quality & Process at Bristol-Myers Squibb, with extensive experience in clinical quality assurance and regulatory supervision.
Current Role at Bristol-Myers Squibb
Grace Kranwinkel, MD, Ccrp, currently serves as Manager, Clinical Quality Assurance, Quality & Process at Bristol-Myers Squibb. In this role, she is responsible for overseeing clinical quality assurance initiatives and ensuring compliance with Good Clinical Practice (GCP) standards. Her duties include GCP compliance consulting, process enhancement, and managing quality issues across various departments.
Previous Work Experience at Celgene
Prior to joining Bristol-Myers Squibb, Grace Kranwinkel worked as a Manager, Clinical Quality Assurance, Quality & Process at Celgene from 2018 to 2019. During her tenure, she focused on quality assurance in clinical settings and contributed to maintaining compliance with regulatory standards. Her role involved planning and conducting GCP audits, as well as preparing audit reports and advising on corrective actions.
Roles at Hackensack University Medical Center
From 2013 to 2018, Grace Kranwinkel held multiple positions at Hackensack University Medical Center, including Research Auditor and Regulatory Supervisor at the John Theurer Cancer Center. In these roles, she was responsible for quality control of research initiatives, conducting audits, and ensuring regulatory compliance. Her work helped streamline processes and maintain high standards for clinical research and care.
Academic Background in Medicine
Grace Kranwinkel completed her Doctor in Medicine degree at Universidad Iberoamericana in Santo Domingo, Dominican Republic, from 1997 to 2001. She also attended Universidad Nacional Pedro Henríquez Ureña from 1995 to 1997 for her undergraduate studies. Her education provided her with a solid foundation in medical sciences and clinical practice, which she has leveraged throughout her career.
Certifications and Training
Grace Kranwinkel holds several certifications, including being a Certified GCP Audit Professional from Barnett. She has also completed training at the Society of Clinical Research Associates (SOCRA). These certifications and trainings highlight her proficiency in clinical quality assurance, FDA inspection preparedness, and GCP compliance consulting. Her expertise ensures that clinical processes adhere to the highest standards of quality and compliance.