Safety Committee Specialist

Job Description

Job Description

We believe that by equipping researchers with rapid insights and providers with tailored, on-demand data, we can help people lead better, healthier lives. At Digital Infuzion, we harness innovative healthcare solutions and cutting-edge bioinformatics to make meaningful impacts in patient care.

Our team thrives in a creative, open, and growth-oriented environment, guided by our core values :

Outcomes First : Focusing on what matters most and making timely, informed decisions.

Innovative : Embracing creativity and continuous improvement to drive novel solutions.

Radical Candor : Communicating openly and honestly, balancing direct feedback with genuine care.

Never Satisfied : Pursuing excellence and continuous growth beyond the status quo.

Resilient : Adapting and persevering through challenges, turning obstacles into opportunities.

If you're passionate about leveraging technology to improve healthcare and want to work in an environment that values innovation and collaboration, we may have just the opportunity for you.

Position Overview

This position reports directly to the Safety Committee Lead and is integral to executing the vision for operational excellence, and continuous improvement in Data Safety Monitoring Board (DSMB) management and operational  processes.

We are seeking a Safety Committee Specialist with strong interest in and experience managing all aspects of DSMB management, The SCS must have documented experience in coordinating and moderating DSMB meetings and management of study documents and related processes. Prior experience in clinical research, Phases 1-IV is required. This role will play a critical part in both ensuring regulatory alignment and overseeing the coordination and logistics needed to support DSMB operations for 30 DSMBs within an electronic management system.

This position is ideal for someone who enjoys building structure, thrives in fast-paced environments, and takes pride in ensuring no detail is overlooked in the service of patient safety and clinical research quality.

Key Responsibilities

Regulatory & Compliance Execution

• Assist in the implementation of DSMB-related Standard Operating Procedures (SOPs) and Working Practice Guidelines in accordance with GCP, FDA, EMA, ICH, and NIH standards.
• Maintain and manage accurate documentation for DSMB charters, rosters, COI forms, DSMB summaries / meeting minutes, and regulatory correspondence.
• Support audits and quality checks related to DSMB activity and compliance status.

Coordination & Logistics Support

Operational Support

Collaboration & Communication

Training & Documentation

What You Will Bring to the Role

Your Experience

Knowledge, Skills and Abilities

Digital Infuzion does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor per Federal laws.

We can provide reasonable accommodation to applicants with disabilities. If you need a reasonable accommodation for any part of the application and hiring process, please contact Human Resources at HR@digitalinfuzion.com. The decision on granting reasonable accommodation will be made on a case-by-case basis.

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