In-House Clinical Research Associate

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POST DATE 8/31/2016
END DATE 10/8/2016

Technical Resources International Inc. Bethesda, MD

Company
Technical Resources International Inc.
Job Classification
Full Time
Company Ref #
352817
AJE Ref #
576029876
Location
Bethesda, MD
Experience
Entry Level (0 - 2 years)
Job Type
Regular
Education
Bachelors Degree

JOB DESCRIPTION

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