Clinical Research Associate with Multilingual Expertise
hace 4 semanas
The Clinical Research Associate (CRA) supports the Global Clinical Operations (GCO) Center of Excellence, conducting activities consistent with GCO's mission of building a world-class shared clinical technology, process innovation, and clinical operations team, in partnership with the company's divisions, through technology enablement, high-touch customer service, study acceleration, and high-quality data collection.
Driving principles and behaviors for this role are caring, diversity, global collaboration, high performance, meaningful innovation, and winning spirit.
Your responsibilities will include:
Working independently and proactively to coordinate all necessary activities for site regulatory submissions and essential document collection for allocated clinical research sites.
Managing multiple sets of essential regulatory documents across several studies and division portfolios.
Partnering with clinical sites to support the negotiation and customization of Informed Consent Form (ICF).
Developing and fostering clinical research site relationships to become a subject matter expert in the site start-up regulatory process across multiple studies.
Leveraging knowledge of site regulatory processes and division priorities to meet clinical study goals and objectives.
Managing to achieve target IRB/EC timelines by assisting clinical research sites with the application submission process and approval tracking.
Managing and problem-solving site start-up challenges that arise to mitigate impact to service level agreements and study goals.
Developing, preparing, completing, and tracking required regulatory, ICF, and legal documentation.
Documenting clinical research site and investigator readiness for participation across multiple studies.
Supporting internal quality audits, regulatory inspections, as applicable.
Updating and maintaining study-specific startup and close-out trackers.
Updating and maintaining site-specific metrics in Clinical Trial Management Systems, file and maintain site documents in eTMFs.
Providing updates to leadership on site start-up activities, investigator readiness, regulatory submission, approval status, etc
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