Sean Kotrady CCRC, CCRP
Vice President of Quality Assurance and GCP Compliance
As the Vice President of Quality Assurance and GCP Compliance, Ms Kotrady provides CRI Lifetree with direction, support, and assistance in all activities regarding FDA regulations, ICH Guidelines, E6, OSHA, HIPPA Regulations and CRI Lifetree internal SOPs, Guidelines, and Policies.
Ms Kotrady has over 19 years of clinical research experience, beginning as a medical assistant and study coordinator. After advancing to a Site Manager, Ms Kotrady provided oversight of clinical operations, quality control, and administration, ensuring compliance, safety and quality of all site operations.. . Ms Kotrady has previously worked as Quality Assurance & Clinical Team Supervisor, ensuring all investigators, coordinators, and staff members were trained and compliant with ICH/GCP, HIPAA regulations, and corporate SOPs. Included in her accomplishments were the development and accuracy completion of study-related documents, oversight of IRB submissions, and coordination and support for sponsor and monitor visits. Ms. Kotrady is a certified member of ACRP and SoCRA. She joined Lifetree Clinical Research ® in 2007 as Senior In-House Clinical Research Associate. She has been responsible for the monitoring of clinical studies conducted on site, provided support for all IRB regulatory issues and ensured company compliance of SOPs and Guidelines. Ms. Kotrady has solid knowledge of FDA Regulations, HIPAA, and IHC/GCP regulations. In addition, Ms Kotrady has performed routine and "for cause” system audits per SOPs, provided quality control for drug preparation and accountability, and performed routine audits of Investigator Site Files.
As Vice President of Quality Control & GCP Compliance Ms Kotrady brings comprehensive clinical research experience and an impressive background in GCP compliance.