Senior Clinical Research Associate-Auditor

MD - Rockville
Jun 13, 2017
Jul 11, 2017
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 Senior Clinical Research Associate to perform site audit visits for complex oncology clinical trials as part of a team comprising representatives from multiple National Cancer Institute (NCI) Clinical Trial Network (NCTN, formerly referred to as the Cooperative Groups) organizations.

Job Responsibilities

Responsibilities include, but are not limited to: attending NCTN and NCI Community Oncology Research Program (NCORP) site audits; coordinating activities of audit teams from multiple NCTN Groups; serving as a resource on NCI Audit Guidelines, federal regulations, and the use of electronic systems; performing and documenting regulatory, pharmacy, and patient case reviews for multiple treatment and/or prevention trials as needed; and supporting site compliance with Good Clinical Practice (GCP).

Job Requirements

· A bachelor's degree in nursing or other health-related field
· 10 years of experience monitoring clinical trials (i.e. on-site monitoring/auditing) with at least 5 of those years being in oncology clinical trials
· The ability to travel 10 days per month

Strong interpersonal skills, exceptional organizational and time-management skills, and writing skills are essential; experience in a leadership role is desired.

Preferred qualifications: A Master's degree in nursing or other health-related field. CCRA is desirable. Clinical experience in oncology and experience with NCI-funded trials, especially NCTN/Cooperative Group trials, are preferred.

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.


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