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Job #02601

About our client Our client is a rapidly growing biotech company headquartered in Northern California that is focused on the development and commercialization of various therapeutics for inflammation and disorders of the nervous system. The company has an experienced management team, multiple programs and an empowering corporate culture that is focused on the professional development of its employees. Position Location Clinical Research Associate East Coast, USA Salary Highly competitive package, commensurate with experience Responsibilities 1) Perform routine site visits, including pre-study, initiation, interim and closeout visits 2) Work with minimal support from the management 3) Ensure compliance with protocol, GCP/ICH guidelines and other applicable regulatory requirements and assurance of good site performance 4) Monitor the informed consent procedures 5) Review subject records, essential documents, investigational product disposition and accountability, site personnel and procedures in detail 6) Manage the assigned sites by regular contacts to ensure site compliance, adequate enrollment and understanding of study requirements 7) Report to project team and site personnel of any findings noted at the monitoring visits 8) Monitor reports and follow-up letters within the project-specific timelines 9) Maintain project-tracking system of subject and site information 10) Participate in company-required training programs 11) Perform necessary administrative functions such as tracking of expense reports, time and attendance 12) Maintain home office such as procurement of office supplies and submission of documents 13) Perform other duties as assigned Requirements 1) Bachelor’s in Life Sciences/Pharmacy/Nursing or a RN 2) Minimum 2 years of clinical/field monitoring experience 3) Ability to work independently in a fast-paced environment 4) Knowledge of Good Clinical Practice, GCP/ICH guidelines and other applicable regulatory requirements 5) Strong communication, interpersonal and organizational skills 6) Willingness to travel - approximately 60% (more during peak times)