Posted:1 hour ago|
Platform:
Work from Office
Full Time
The Study Start-Up Clinical Research Associate (SSU CRA) plays a critical role in ensuring efficient and compliant trial start-up activities at clinical sites. This position is responsible for site selection, preparation, and activation for Phase I-IV clinical trials. SSU CRA acts as the primary liaison between the sponsor and the site during the start-up phase, ensuring all regulatory, ethical, and operational requirements are met to achieve site readiness. About the Role Key Responsibilities: Lead and execute site selection and start-up activities from country allocation to site greenlight. Serve as the main point of contact for trial sites during start-up, including IRB/IEC and Health Authority submission preparation. Ensure timely collection and submission of site-specific documents (e. g. , CVs, GCP certificates, financial disclosures). Support the preparation of country-specific documents and patient-facing materials. Coordinate vendor setup and assist with financial contract negotiations with investigational sites. Maintain accurate and up-to-date documentation in Trial Master File (TMF) and internal systems. Collaborate with internal stakeholders to ensure seamless handover to execution CRAs and readiness for audits and inspections. Essential Requirements: Bachelor s degree in a scientific or health discipline; clinical operations experience preferred. Minimum 3 years of experience in clinical operations, particularly in site management or monitoring. Strong knowledge of ICH/GCP guidelines, local regulatory requirements, and clinical trial processes. Excellent interpersonal, negotiation, and conflict resolution skills. Proven ability to manage multiple priorities and adapt to fast-changing environments. Willingness and ability to travel for site visits and meetings.
NOVARTIS
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