Senior Clinical Research Associate

Employer
Westat
Location
Rockville, VA
Posted
Aug 19, 2020
Closes
Sep 18, 2020
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 an experienced senior clinical research associate to oversee and coordinate site monitoring visits at clinical centers conducting a commercial-sponsored covid-19 treatment study conducted in the U.S.  The opening is available in a regional home-based office.

Job Responsibilities:
• Lead development and revisions to the site monitoring plan supporting compliance with the research protocol, ICH/GCP, FDA, EU and other applicable regulations.
• Manage and serve as a resource to  CRAs conducting remote site monitoring visits, using a risk based and centralized monitoring approach
• Communicate directly with the study sponsor on monitoring targets and strategies, monitoring schedule and findings; participate in sponsor meetings with project management team.
• Review site monitoring reports.
• Support site compliance with Good Clinical Practice (GCP) including site training, performance improvement recommendations, and corrective and preventive action plans (CAPA).
• Contribute to site training, risk assessment, and quality assurance practices.

Basic qualifications: 
• A bachelor's degree in nursing or other health-related field with at least 10 years of clinical research experience and monitoring oversight experience is required.
• Exceptional knowledge of GCP Guidelines and FDA regulations is required.
• Robust experience with risked based and central monitoring.

Strong interpersonal skills, exceptional organizational and time-management skills, and writing skills are essential.  

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

Westat is an Equal Opportunity Employer and does not discriminate on the basis of race, creed, color, religion, sex, national origin, age, veteran status, disability, marital status, sexual orientation, citizenship status, genetic information, gender identity or expression, or any other protected status under applicable law.

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