Senior Administrator, Data Safety and Monitoring Committee

Role Overview

• Supports and coordinates the Data Safety and Monitoring Committees (DSMC)
• Provides quality data in order to respond to the DSMP requirements
• Process, review, and assess SAE, device incident, and pregnancy reports from clinical trials
• Maintains, revises, and oversees the Data Safety and Monitoring Plan (DSMP)
• Independently verifies submitted protocols meet requirements for placement on committee agenda
• Coordinates and attends Data Safety and Monitoring Committee meetings
• Compiles agendas, assigns committee reviewers, composes official minutes, and constructs reports
• Prepares DSMC documents in collaboration with the study PI

Requirements

• Bachelor's degree in a related field (scientific or health related)
• Seven years of experience in clinical trials management, sponsored research, or regulatory management
• Five years trial or related monitoring experience
• Certification by Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ASCP) is required within three (3) years of hire

Benefits

• Health and safety information
• The possibility of hybrid work arrangement