• Monitor study activities to ensure compliance with protocols and with all relevant local, state, and federal regulatory and institutional policies
• Maintain required records of study activity including case report forms, drug dispensation records, or regulatory forms
• Review scientific literature, participate in continuing education activities or attend conferences and seminars to maintain current knowledge of clinical studies affairs and issues
• Register protocol patients with appropriate statistical centers as required
• Prepare for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups
• Perform specific protocol procedures such as interviewing subjects, taking vital signs and performing EKG’s
• Oversee subject enrollment to ensure that informed consent is properly obtained and documented.
• Organize space for study equipment and supplies
• Maintain contact with sponsors to schedule and coordinate site visits or to answer questions about issues such as incomplete data
• Schedule subjects for appointments, procedures, or impatient stays as required by study protocols