Aimee Dunn
Regulatory Support, Contract Administrator
Aimee Dunn is currently the Regulatory Associate for CovarsaDx. She has 15 years of experience in the Clinical Research field. Aimee is responsible for study and site level regulatory preparation and submission as well as assisting with the development of study budgets and contracts for all of our clinical research sites.
She has also created end-user work instructions and training materials for medical device trials as well as coordinated Phase II to IV clinical research trials for private and academic settings. In addition, Aimee has handled the recruitment and pre-screening of subjects, and scheduled and facilitated study visits. Her previous experience also involves clinical duties such as lab sampling, electrocardiogram testing, pulmonary testing, and biometrics.
Aimee is adept at project management, having managed 2 to 3 simultaneous protocols across multiple sites, applied an understanding of FDA regulations and GCP and ICH guidelines, and created study-related documents like ICFs, CRFs, and study questionnaires. She has a working knowledge of EDC, eCRF, and query resolution.
Aimee has authored technical and end-user documentation for software/hardware, facilitated protocol-specific training for internal/external customers, and managed document vault editing, versioning, and archiving.
She received her Bachelor of Science in Sociology from Colorado State University and is a Certified Medical Assistant.
She has also created end-user work instructions and training materials for medical device trials as well as coordinated Phase II to IV clinical research trials for private and academic settings. In addition, Aimee has handled the recruitment and pre-screening of subjects, and scheduled and facilitated study visits. Her previous experience also involves clinical duties such as lab sampling, electrocardiogram testing, pulmonary testing, and biometrics.
Aimee is adept at project management, having managed 2 to 3 simultaneous protocols across multiple sites, applied an understanding of FDA regulations and GCP and ICH guidelines, and created study-related documents like ICFs, CRFs, and study questionnaires. She has a working knowledge of EDC, eCRF, and query resolution.
Aimee has authored technical and end-user documentation for software/hardware, facilitated protocol-specific training for internal/external customers, and managed document vault editing, versioning, and archiving.
She received her Bachelor of Science in Sociology from Colorado State University and is a Certified Medical Assistant.