Clinical Research Associate

Employer
Westat
Location
Rockville, VA
Posted
May 23, 2019
Closes
Aug 08, 2019
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 regionally-based clinical research associate to perform site monitoring visits in the West Coast U.S.


Job Responsibilities:


· 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


Basic qualifications:


· 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.