Director Of Regulatory Affairs And Site Management
Current- Co-founded and led the development of a clinical research site network, achieving $10M+ revenue in the first 2 years of operation. - Manage study start-up activities, including development of study protocols and informed consent forms, preparation of regulatory submissions, and coordination of IRB reviews.- Provide oversight for ongoing monitoring visits to ensure compliance with study protocols, regulatory requirements, and ethical standards.- Manage and provide leadership for a team of regulatory professionals, including training and development, performance management, and workload distribution.- Develop and implement quality control processes and procedures to ensure the highest level of data integrity and patient safety.- Led study start-up activities, including development of study protocols and informed consent forms, preparation of regulatory submissions, and coordination of IRB reviews for over 35 clinical trials.- Managed ongoing monitoring visits to ensure compliance with study protocols, regulatory requirements, and ethical standards, resulting in successful outcomes for patients and sponsors.- Provided oversight and leadership for a team of regulatory professionals, including training and development, performance management, and workload distribution.- Developed and implemented quality control processes and procedures to ensure the highest level of data integrity and patient safety, resulting in improved efficiency and reduced costs.- Built and maintained productive relationships with external stakeholders, including sponsors, regulatory agencies, and research institutions.- Managed and provided oversight for sponsor and FDA audits, ensuring compliance with all regulatory requirements and ethical standards.- Collaborated with cross-functional teams, including clinical operations, data management, and biostatistics, to ensure successful execution of clinical trials.