- Quality Control Specialist
Danielle Lone is the Quality Control Specialist of Segal Trials and is responsible for working collaboratively with staff and management to develop, verify and implement procedures to accomplish research quality management goals, in compliance with the company Quality Improvement SOP as well as GCP and federal regulations. She verifies the integrity of clinical data with respect to accuracy, accountability, thoroughness, timeliness, documentation and methods or procedures through QC of electronic data/CRFs, source documents, medical records and regulatory documents.
Additionally, Danielle tracks staff trainings to ensure compliance with GCP requirements, implements training programs in Compliance and Quality Assurance as well as oversees QC associates. She assists clinical operations in development and revisions of the SOPs, the preparation of CAPAs as well as in preparation for regulatory inspection and audits.
Danielle joined Segal Trials in 2018 as Regulatory Coordinator having previously worked in Hepatology clinical research at the University of Miami and Schiff Center for Liver Diseases. Danielle holds a Bachelor of Science in Biomedical Engineering form the University of Miami with a concentration in Medicine.