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.
An initiation Clinical Research Associate (iCRA) specializing in Pre SIV and Activation tasks will be assigned & accountable for managing and driving the strategy for the startup, Pre SIV and Activation tasks of the study. The iCRA also supports submission and approval process for the protocol amendments if applicable.
Key Accountabilities:
Start-up (from site identification through site activation):
Act as Parexel’s direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase.
• Build relationships with investigators and site staff.
• Support on request country specific feasibility and/or site pre-qualification and qualification activities, which may include:• Preparation, negotiation, and facilitation of execution of Confidentiality Agreements (CDA) and any amendments.
• May conduct remote Qualification Visits (QVs).
• Liaison with stakeholders to understand Clinical Site Agreements (CSA) timelines.
• Manage country and site level TMF issues ensuring documents’ First Time Quality (FTQ) as well as providing direct resolution to reported site problems.
• Develop strategy to configure, distribute, collect, and review and approve, high quality country specific and/or site specific documents or essential regulatory documents (Site SIV Readiness/Greenlight Documents) and any updated or amended regulatory documentation.
• Customize, review, and negotiate as needed, country/site specific