In-House Clinical Research Associate
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This position will review and process essential regulatory documents received from clinical trial sites; request additional information when necessary; respond to protocol and process-related queries; maintain trial master files, and track the process in a centralized Web-based system and/or other databases. Requirements include Bachelor s degree in life sciences or other health-related field; 0 - 2 years of experience in the clinical research arena; and proficiency with Microsoft Office.
Essential Duties and Responsibilities:
Review essential regulatory documents (ERD) for accuracy and completeness as required by FDA Regulations, ICHGCP, Sponsor s Requirements and SOPs.
Essential regulatory document collection, tracking, and transmittal using electronic systems, interfaces, and databases.
Adherence to strict project timelines and expectations.
Troubleshoot ERD issues by applying existing knowledge to solve new problems