Regulatory Affairs Research Associate

Employer
Location
MD - Rockville
Posted
Apr 18, 2017
Closes
May 06, 2017
Function
Analyst, Research
Industry
Research
Hours
Full Time
Westat is an employee-owned corporation providing research services to agencies of the U.S. Government, as well as businesses, foundations, and state and local governments. Westat's research, technical, and administrative staff of more than 2,000 is located at our headquarters in Rockville, Maryland, near Washington, DC.

Job Summary


Westat is seeking a qualified Regulatory Affairs (RA) Research Associate to support clinical trials regulatory compliance for a contract research organization (CRO).

Job Responsibilities


Responsibilities include, but are not limited to: writing and compiling regulatory documents for submissions to health authorities; performing regulatory review and approval of site regulatory documents prior to trial initiation; interacting with site study coordinators and investigators, developing a conducting trainings, independently researching and writing on assigned topics; providing regulatory guidance in cross-functional teams; performing regulatory review of trial related documents, processing of serious adverse event reports; creating, updating, and tracking study-specific regulatory files; providing support to the Regulatory Affairs Director; ensuring that all work activity is performed in accordance with established procedures and regulatory requirements.

Job Requirements


· A bachelor's degree in science, nursing, or other health-related field
· 6 years of Regulatory Affairs experience in clinical trials with working knowledge of US Federal regulations and ICH guidelines for Good Clinical Practices.

The qualified candidate must possess strong oral and written communication skills, excellent attention to detail, managing and adhering to timelines, and the ability to work and collaborate closely with all departments. Strong working knowledge of various computer applications and the ability to quickly gain knowledge of internal databases is essential.

Westat offers competitive benefits with ESOP, 401k, Health, Dental, paid vacation, sick and holiday leave, professional development as well as other benefits.

Any offer of employment may be contingent upon receipt of acceptable results from a post-offer background screening, if required for the position, based on the specific position which may include, for example, identity verification, employment history, or criminal records history.

Westat is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, sex, age, national origin, veteran status, disability, or any other classification protected by Federal, state, or local law.

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