JOB INTERACTIONS AND INTERFACE: This position interacts with Site Director, Sub-Investigators, Staff, Sponsors, CROs, Ethics Review Boards and study subjects. We OB/GYN, Dermatology and Internal Medicine MDs
• Conduct of the clinical investigation
• Understanding of the requirements of each protocol
• Determine inclusion/exclusion for each Subject
• Assist with recruitment goals
• Assess overall protocol feasibility
• Conduct study procedures
• Evaluate for adverse events
• Report all serious adverse events immediately to the sponsor and IRB
• Comply with written procedures to document changes to data and/or case report forms
• Communicate effectively with subjects, research team, IRB, CRO and sponsor
• Meet regularly with the research team to discuss subject participation and protocol progress
• Ensure that all research staff are trained on the protocol and study specific procedures
• Prepare for and Attend Investigator meetings, site monitoring visits, audits, etc.
Role: PI for Clinical Research Site
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