Medpace

Clinical Research

• Travelling to study sites (Germany-wide) to conduct qualification, initiation, monitoring, and closeout visits in compliance with the approved protocol
• Communication with the medical site staff including coordinators, clinical research physicians and their site staff
• Verifying 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
• 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
• Assessing the clinical research site’s patient recruitment and retention success and offering 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.

Clinical Research Associate, Virtual Event

• Communicate and collaborate on global study activities; working closely with the project coordinator and clinical trial manager
• Ensure timely delivery of recurrent tasks consistently with a high degree of accuracy
• Compile and maintain project-specific status reports within the clinical trial management system
• Interact with the internal project team, Sponsor, study sites, and third-party vendors
• Provide oversight and quality control of our internal regulatory filing system
• Provide oversight and management of study supplies
• Create and maintain project timelines
• Coordinate project meetings and produce quality minutes

Clinical Research Associate, Virtual Event

Associate Clinical Trial Manager – Cardio, Renal, GI, Metabolic