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Regulatory Associate

Pinnacle Clinical Research • Bellaire, TX, US • published 2026-10-29 21:15:52.584885

Description

**Summary:** The Regulatory Associate supports clinical research trials by ensuring the timely and accurate preparation and submission of regulatory and IRB documentation for new and ongoing studies. On average, this position provides primary regulatory support for approximately 45 clinical trials across multiple sites. The Regulatory Associate works closely with Investigators, Clinical Operations, Sponsors, CROs, IRBs, and other stakeholders to ensure the research site follows applicable regulations, GCP, ICH guidelines, HIPAA, sponsor requirements, and company SOPs for the conduct of clinical pharmaceutical and device protocols. The Regulatory Associate serves as a key point of coordination for regulatory compliance throughout the study lifecycle and is responsible for preparing and maintaining regulatory documents, tracking submissions, approvals, and expiring documentation, facilitating communication with internal and external stakeholders, and identifying outstanding items that may impact study timelines or compliance. This position works under limited supervision, applies ethical principles and multiple regulations to complex research projects, and always maintains the confid...

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