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Senior Administrator, Data Safety and Monitoring Committee
Emory University. Supports and coordinates the Data Safety and Monitoring Committees (DSMC) .
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- Health and safety information
- The possibility of hybrid work arrangement
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
data safety monitoringclinical trials managementSAE processingdata safety and monitoring plan (DSMP)protocol verificationreport compilationagenda preparationclinical monitoring
Soft Skills
coordinationcommunicationorganizational skillsindependenceattention to detail
Certifications
Society of Clinical Research Associates (SOCRA)Association of Clinical Research Professionals (ACRP)