Clinical Trial Assistant

Monitor study activities to ensure compliance with protocols and local, federal, and state regulatory policies. Maintain required records including case report forms, drug dispensation records, and regulatory forms. Order drugs or devices necessary for study completion and dispense medical devices or drugs while calculating dosages. Prepare for and participate in quality assurance audits conducted by study sponsors or federal agencies. Organize space for study equipment and supplies and maintain current lists of correspondence. Administer clinical trials according to good clinical practices and standard operating procedures. Provide general logistical support by entering subject and study site orders and arranging deliveries of study medications and supplies. Maintain contact with sponsors to schedule and coordinate site visits or answer questions about issues such as incomplete data. Identify protocol problems, inform investigators, and assist in problem resolution efforts such as protocol revisions. Some travel may be required.