Responsibilities

• Monitor study activities to ensure compliance with protocols and all relevant local, federal, and state regulatory and institutional polices.
• Maintain required records of study activity including case report forms, drug dispensation records, and regulatory forms.
• Order drugs or devices necessary for study completion.
• Maintain current knowledge of clinical studies affairs and issues by reviewing scientific literature, participating in continuing education activities, and attending conferences and seminars.
• Prepare for and participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.
• Organize space for study equipment and supplies.
• Participate in the development of study protocols including guidelines for administration or data collection procedures.
• Maintain contact with sponsors to schedule and coordinate site visits or to answer questions about issues such as incomplete data
• Identify protocol problems, inform investigators of problems, and assist in problem resolution efforts such as protocol revisions.
• Dispense medical devices or drugs, and calculate dosages and provide instructions as necessary.