Initiation Clinical Research Associate - iCRA

When our values align, there's no limit to what we can achieve. At Parexel , we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel , contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. The Initiation Clinical Research Associate (iCRA) is responsible for leading and executing all study start-up, pre-SIV, activation, and protocol amendment activities from site identification through site activation and maintenance. Acting as the primary contact for assigned sites, the iCRA manages regulatory submissions, site readiness, document quality, and activation timelines while ensuring compliance with sponsor, regulatory, and company requirements. Key responsibilities include: Managing site start-up activities from feasibility and qualification through activation. Building strong relationships with investigators and site staff. Preparing, reviewing, negotiating, and executing regulatory and site documents, including CDAs, ICFs, translations, and amendments. Coordinating submissions and approvals with IRBs/IECs, Ministries of Health, and Regulatory Authorities. Developing and tracking activation strategies, timelines, and regulatory