Kendall Clark

Clinical Research Associate @Medpace

Denver, CO, US

Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol• Communicate 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• Verify medical record and research source documentation 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• Complete on-site and virtual/remote monitoring activities with a risk-based monitoring approach (including centralized data review) through an 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• Verify that the investigator is enrolling only eligible subjects• Review regulatory documents• Conduct accountability and inventory of medical devices and/or investigational products• Verify 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 offer suggestions for improvement• Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance

James Madison University

Bachelor’s Degree

James Madison University

Master of Science - MS