Kevin Van Leer is a dedicated and meticulous Certified Clinical Research Associate (CCRA) with approximately 10 years of comprehensive experience in the pharmaceutical and biotechnology industries. He specializes in monitoring clinical trials across various therapeutic areas, ensuring adherence to protocols, Good Clinical Practice (GCP) guidelines, and regulatory requirements. Kevin is proficient in all aspects of site management, including site initiation, interim monitoring, and close-out visits. He excels in building strong relationships with investigative site staff, resolving discrepancies in clinical data, and ensuring patient safety and data integrity. His commitment to quality and detail contributes significantly to the successful execution and completion of clinical studies.
Kevin Van Leer's work history includes a series of influential roles in various companies. Here is a detailed list of his professional journey:
Successfully obtained and maintains the CCRA credential through the Society of Clinical Research Associates (SoCRA), demonstrating a high level of knowledge, competence, and ethical practice in clinical research monitoring.
Repeatedly achieved positive outcomes in internal and external audits of monitored sites, reflecting a strong commitment to quality assurance and compliance with GCP and regulatory standards.
Played an integral role in managing and monitoring pivotal Phase III trials that led to a successful New Drug Application (NDA) submission and subsequent market approval for a novel therapeutic agent.
Actively involved in training and mentoring junior CRAs, sharing best practices in site management, monitoring techniques, and regulatory compliance to foster their professional development within the organization.
University of Illinois at Urbana-Champaign - Year 2011
Purdue University - Year 2007
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