The associate is responsible for coordinating regulatory and ethics submissions, supporting site training and documentation, and maintaining inspection readiness through accurate and complete trial records, including the Trial Master File (TMF). Additional responsibilities may be assigned based on local regulatory requirements, geographic needs, or regional operational differences.
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Support investigator site start-up activities, including collection, review, and submission of regulatory documentation
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Coordinate customization and negotiation of informed consent documents
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Act as the primary liaison with Ethics Review Boards (ERBs) and Competent Authorities (CAs), where applicable
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Track and ensure site compliance with required training and regulatory obligations
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Drive site activation and maintenance timelines in alignment with study and organizational priorities
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Maintain regular communication with investigator sites throughout start-up, maintenance, and close-out phases
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Proactively identify, escalate, and resolve site-related issues
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Ensure country-specific regulatory and data privacy requirements are reflected in submissions, documents, and systems
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Utilize prior site and ethics committee experience to streamline start-up and regulatory processes
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Maintain accurate and up-to-date information in internal tracking systems related to trial and site performance
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Ensure compliance with procurement, legal, and financial processes
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Populate and maintain Trial Master Files and document repositories to support audit and inspection readiness
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Share feedback and lessons learned to support continuous process improvement
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Manage competing priorities and adapt to changing study or portfolio demands
