Clinical Research Regulatory Coordinator- 225808

1 month ago

Pascagoula, United States Medix™ Full time

Job Description:

Reporting to the Director of Clinical Research, the Regulatory Analyst plays a pivotal role in ensuring compliance within clinical research projects. The primary responsibility involves completing and maintaining regulatory documents, aligning with study protocols, institutional policies, relevant regulations, and Good Clinical Practice (GCP) Guidelines.

Responsibilities include overseeing day-to-day regulatory operations, managing study intake and feasibility assessments, facilitating start-up processes, handling Institutional Review Board (IRB) and Sponsor submissions, managing modification submissions, ensuring continuous reporting, and overseeing study close-out procedures. Additionally, the role encompasses providing financial support, liaising with internal and external stakeholders, and engaging with regulatory agencies as necessary.

The Regulatory Analyst will maintain centralized documents, including credentials and training files for study staff, laboratory documents, and IRB manuals, forms, and other pertinent documents. Administrative duties will be performed as required, all while upholding the mission, vision, and values of Singing River Research (SRR) / Singing River Health System (SRHS).

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