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.
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.
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).
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.
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 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. In addition to our capabilities as a leading statistical survey research organization, Westat has developed skills and experience in custom research and program evaluation studies across a broad range of subject areas. Westat a...lso has the technical expertise in survey and analytical methods, computer systems technology, biomedical science, and clinical trials to sustain a leadership position in all our research endeavors.
Westat's research, technical, and administrative staff of more than 2,000 is located at our headquarters in Rockville, Maryland, near Washington, DC. Depending on the number of active projects at any time, up to several thousand data collection and processing staff work at Westat's survey processing facilities, at our Telephone Research Center facilities, and at data collection sites throughout the nation. Westat also maintains research offices near our clients in Bethesda, Maryland; Raleigh, North Carolina; Atlanta, Georgia; and Houston, Texas.
Demonstrating technical and managerial excellence since 1963, Westat has emerged as one of the foremost contract research organizations in the United States.