CovarsaDx

Michael Varisella

Clinical Research Associate

Michael Varisella, a Clinical Research Associate, aids with the execution and management of CovarsaDx’s key clinical research projects. With more than 10 years of experience, he has worked in over one hundred Phase III and Phase IV trials in the fields of psychiatry and pulmonary medicine.

During his professional journey, Michael has worked with top pharmaceutical companies where he had successfully managed clinical trials such as patient pre-screening and onboarding, conducting preliminary assessments, completing case report forms, and responding to data queries. In addition, Michael has experience in advising patients on study guidelines, updating regulatory information, and ensuring that ethical standards are upheld throughout all study activities.

As a Clinical Research Associate, Michael is responsible for developing site contact reports and monitoring reports, documenting study communication and visits. This ensures compliance with standard operating procedures and regulations, and aligns with FDA, ICH, and GCP guidelines. He plays a crucial role in site identification and qualification, site initiation visits, and site close out visits. He also performs study monitoring, manages regulatory documents, and source data verification.

Michael holds a Bachelor of Arts in Psychology from the University of Missouri, Columbia.
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