Allison Dymacek

Background

About Allison Dymacek

I am a Clinical Research Professional specializing in Regulatory and Start-up support. My experience also includes working with Investigational New Drug (IND) applications and other communications with the FDA. I have over nine years of experience in clinical research, including six years specifically in regulatory and start-up support. During this time, I have developed a strong understanding of the regulations and guidelines that govern clinical research. I am particularly knowledgeable in the area of start-up, having operationalize over 100 trials for various therapeutic areas, including oncology, cardiovascular, and brain and spine. I have extensive experience in clinical trial operations, feasibility assessments, project management, and research education. Additionally, I have experience in preparing regulatory documents such as Informed Consent Forms (ICF), FDA Form 1572s, and IRB applications. I am a highly organized and detail-oriented individual with excellent communication and problem-solving skills. I strive to stay up to date with the latest developments in the industry through continuing education and professional networking. My ultimate goal is to help bring new treatments to patients in the community.