Westat is seeking a qualified regionally-based clinical research associate to perform site monitoring visits in the West Coast U.S.
Conduct site initiation visits, interim visits, and close-out visits of multiple therapeutic areas assessing compliance with the research protocol, ICH/GCP, FDA, and other applicable regulations
Develop site monitoring plans of on-site and remote monitoring requirements, including risk assessment and management
Support site compliance with Good Clinical Practice (GCP) including site training, performance improvement recommendations, and corrective and preventive action plans (CAPA)
Write detailed report of findings for sponsor review, including corrective and preventive actions, and recommendations for process improvement
A bachelor's degree in nursing or other health-related field with at least 8 years of clinical research experience required.
Knowledge of GCP Guidelines is required.
Bilingual Spanish is preferred. Strong interpersonal skills, exceptional organizational and time-management skills, and writing skills are essential. The selected candidate must be willing to travel 10 days per month.
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, national origin, age, veteran status, disability, marital status, sexual orientation, citizenship status, genetic information, gender identity, or any other protected status under applicable law.
Internal Number: 15021BR
WESTAT, located in Rockville, MD is one of the foremost contract research corporations in the United States. Since 1961, we have conducted surveys and provided statistical research and related services to the agencies of the U.S. Government and to a broad range of institutional and business clients. We are an employee-owned corporation with more than 2,000 research, technical, and administrative staff and a recognized history of technical and managerial excellence.