Clinical Research Associate

Responsibilities

• Travel to investigative sites to conduct site qualification, initiation, interim monitoring, and close-out visits
• Aid in the selection of potential investigators
• Conduct initial and ongoing site training throughout the course of the study
• Evaluate investigator compliance with the study protocol and applicable regulations
• Verify sites are collecting all required source data per protocol, accurately completing Case Report Forms, and resolving all data queries
• Review the regulatory binder and essential documents at the site and verify all documents are appropriately filed
• Oversee and conduct monitoring activities, including remote monitoring when applicable
• Verify investigational product is properly stored, dispensed, returned, and that accountability of the product and masking requirements are maintained throughout the study
• Assigned sites through regular contact with investigators and site staff to monitor progress, answer questions, and provide guidance during the course of the clinical study
• Critically review and analyze site activities through frequent visits and contacts to monitor study sites and performance
• Build relationships with the Investigators and site staff to enhance productivity, as well as collaborate with study management on protocol discrepancies, improving efficiency, and monitoring data integrity
• Manage the progress of assigned studies by tracking subject enrollment, data collection, CRF completion, source data verification, data query generation and resolution, and investigational product accountability
• Maintain strong productive relationships with study investigators, site staff, and study management personnel, including assessment and resolution of existing relationship issues
• Create and maintain appropriate documentation (e.g., visit reports/letters)
• Works independently with seldom supervision
• Mentor/train new CRAs
• Conduct peer to peer review visits
• Provide FDA inspection support
• Maintain strong productive relationships with study investigators, site staff, and study management personnel, including assessment and resolution of existing relationship issues
• Participate in the development of source document templates, CRFs, CRF completion guidelines, monitoring plans, etc.
• Executes department projects

Requirements

• Experience medical device and pharmaceutical industry is preferred, and ophthalmology experience is strongly preferred for all levels
• Knowledge and understanding of Good Clinical Practices (ICH E6 R2)
• Knowledge and understanding of FDA’s Code of Federal Regulations applicable to conducting clinical research studies
• Must have proficient computer skills and experience with Microsoft Office
• Must be willing and able to travel approximately 75-80%, including overnight, domestic and international
• Self-directed behavior