Louisville, KY30+ days ago
p>Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol; Communication with the medical site staff including coordinators, clinical research physicians, and their site staff; Verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff; Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements; On-site and virtual/remote monitoring activities with a risk-based monitoring approach (including centralized data review) through our integrated Clinical Trial Management System to identify site deviations/deficiencies and corrective/preventive actions to bring a site back into compliance and mitigate risks moving forward; Verification that the investigator is enrolling only eligible subjects; Regulatory document review; Medical device and/or investigational product/drug accountability and inventory; Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol; Assess the clinical research site's patient recruitment and retention success and offering suggestions for improvement; and Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance. Flexible work environment Competitive PTO packages, starting at 20+ days Competitive compensation and benefits package Company-sponsored employee appreciation events Employee health and wellness initiatives Community involvement with local nonprofit organizations Discounts on local sports games, fitness gyms and attractions Modern, ecofriendly campus with an on-site fitness center Structured career paths with opportunities for professional growth Discounted tuition for UC online programs Awards Named a Top Workplace in 2024 by The Cincinnati Enquirer Recognized by Forbes as one of Americas Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility.