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Responsibilities

• Perform routine site visits, including pre-study, initiation, interim, and closeout visits. Performs responsibilities with minimal support from management. Visits to include monitoring of proper informed consent procedures, compliance with protocol, GCP/ICH Guidelines and other applicable regulatory requirements, and assurance of good site performance. This is accomplished by detailed review of subject records, essential documents, investigational product disposition and accountability, site personnel and procedures.
• Manage assigned sites by regular contacts to ensure site compliance, adequate enrollment, and understanding of study requirements.
• Report to i3 Research project team, client, and site personnel any findings noted at monitoring visits. This is accomplished by completion of monitoring reports and follow-up letters within the project-specific timelines. Significant issues noted must be reported to appropriate personnel immediately.
• Maintain eClinical or alternative project tracking system of subject and site information.
• Participate in company-required training programs.
• Perform necessary administrative functions (e.g., tracking of expense reports, time and attendance).
• Maintain home office (e.g., procurement of office supplies, submission of documents).
• Perform other duties as assigned.

Qualifications

• Bachelor's level degree in life sciences, pharmacy, nursing or RN preferred
• Two to five years clinical monitoring experience
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Ability to work independently in a fast-paced environment
• Strong communication, interpersonal, and organizational skills
• Must demonstrate good computer skills
• Position requires approximately 60% travel (may be up to 80% during peak times)