DSMB Operations & Compliance Specialist

Digital Infuzion, Inc.; Rockville (MD); Presencial; USD 90 000 - 140 000; Tempo integral

Resumo da oferta

Digital Infuzion, Inc. seeks a Safety Committee Specialist (SCS) with a strong focus on clinical trial safety, regulatory compliance, and DSMB logistics across 30 boards in an electronic management system.

The role reports to the Director of Clinical Research Solutions and suits someone who thrives on structure, fast-paced environments, and meticulous detail in service of patient safety and research quality.

Qualificações

• Bachelor’s degree in life sciences or related field.
• 5+ years clinical research experience.
• 2+ years DSMB experience.
• Strong documentation and regulator-ready output.
• Excellent communication and organizational skills.

Responsabilidades

• Regulatory & Compliance Execution: manage DSMB charters, SOPs/WPGs alignment with GCP, FDA, EMA, ICH, NIH.
• DSMB Leadership: coordinate meetings, track actions, and liaise with internal/external stakeholders.
• Operational Support: maintain electronic DSMB records, generate progress reports, flag risks.
• Training & Documentation: develop training materials and onboard new DSMB staff.

Conhecimentos

Clinical research

DSMB coordination

Regulatory compliance

Documentation

Communication

Formação académica

Bachelor's degree in life sciences or related field

Descrição da oferta de emprego

Digital Infuzion, Inc. seeks a Safety Committee Specialist (SCS) with a strong focus on clinical trial safety, regulatory compliance, and DSMB logistics across 30 boards in an electronic management system.

The role reports to the Director of Clinical Research Solutions and suits someone who thrives on structure, fast-paced environments, and meticulous detail in service of patient safety and research quality.