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TEAM PARTNERS

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Caitlin Joffe

With over 18 years of experience in the clinical research space, Caitlin has developed extensive expertise in the oversight and management of clinical trials, particularly in IND/IDE studies, multi-site trials, and oncology research. She began her career as a study coordinator, gaining experience in industry-sponsored and multi-site studies, before expanding her expertise to regulatory submissions, including IRB, NCI, and FDA documentation. Having spent time working for a phase I oncology clinical trials unit in Madrid, Spain for START and the SKCCC at Johns Hopkins University, Caitlin has also gained valuable expertise in conducting trials internationally.  Over the years, she transitioned into roles with increasing responsibility, ultimately specializing in quality assurance and research compliance.

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In her current role as the Director of Research Quality Assurance, Caitlin manages the research quality assurance program, ensuring the integrity and compliance of clinical trials across multiple departments. She oversees the implementation of policies and procedures to maintain high-quality research practices, focusing on IND/IDE studies and multi-site investigator-initiated trials. She also leads a team of quality assurance professionals, providing training and support on regulatory compliance, quality assurance principles, and responsible conduct of research.

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Throughout her career, Caitlin has developed and led several key initiatives to enhance research processes, including establishing data quality standards, improving research practices, and managing regulatory compliance for clinical trials. She works closely with research teams and senior leadership to drive continuous improvements and ensure the successful execution of high-quality, ethical research.

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Caitlin is committed to education and training. She regularly develops and leads educational programs for research teams, ensuring that staff remain up-to-date with the latest regulatory standards and best practices. She is a member of SOCRA, further demonstrating her dedication to advancing the field of clinical research and quality assurance.

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She holds a BA from Smith College and an MBA from Johns Hopkins University.

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