Responsibilities : 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 siteâs patient recruitment and retention success and offering suggestions for improvement; and. Qualifications : Must have a minimum of a Bachelorâs degree in a health or science related field; Experience as a Clinical Research Coordinator (minimum 1 year); Ability to travel 60-70% to locations nationwide is required; some visits may be conducted remotely; Must maintain a valid driverâs license and the ability to drive to monitoring sites; Proficient knowledge of MicrosoftÂź Office; Strong communication and presentation skills; and.