Safety Committee Specialist, DSMB and Documentation

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 youre 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:
We are seeking a Safety Committee Specialist (SCS) to support and strengthen safety monitoring operations within a federal clinical research portfolio. This role is central to the day-to-day execution of Data and Safety Monitoring Boards (DSMBs) activities with a primary emphasis on writing maintaining and operationalizing procedures and work practices that ensure inspection-ready documentation and consistent delivery. This SCS will own the programs Quality Management System (QMS).

Reporting to the Director of Clinical Research Solutions the SCS will own key coordination documentation control and compliance workflows within an electronic DSMB management environment - while producing clear Standard Operation Procedures (SOPs) work instructions checklists templates and process maps that enable consistent scalable operations.

Core Responsibilities:
Procedure & Process Writing (Primary Emphasis)

• Draft revise and maintain SOPs Work Practice Guidelines (WPG) work instructions checklists templates and process maps supporting DSMB operations.
• Translate operational requirements into clear step-by-step procedures that can be executed consistently across staff and committees.
• Develop and maintain standardized templates (agendas minutes decision letters tracking logs checklists) to reduce variability and rework.
• Maintain the projects Quality Management System a controlled library of procedures and templates including version control effective dates review cycles and documented change history.
• Partner with leadership to identify process gaps; propose updates and drive implementation through documentation training and adoption support.
• Tailor artifacts based on the audience for which materials will be used.

• Maintain and quality-check DSMB core files (as applicable): charters rosters COI forms meeting minutes decision letters and regulatory correspondence.
• Ensure documentation meets standards for traceability completeness naming conventions and version control in the electronic DSMB management system.
• Support audit readiness activities including internal QC checks findings remediation documentation standardization and readiness tracking.
• Systems Tracking and Operational Reporting
• Maintain accurate system-driven records enabling real-time visibility of schedules member status meeting outcomes and compliance milestones.
• Produce routine operational reports and dashboards for internal leadership and external stakeholders as required.
• Identify workflow inefficiencies and recommend enhancements to improve efficiency and reduce manual burden while maintaining compliance.

• Coordinate DSMB meetings end-to-end: agenda development scheduling calendar invitations material compilation distribution and follow-up.
• Track action items decisions and required follow-ups to closure; escalate risks to leadership early with recommended next steps.
• Coordinate member onboarding and documentation (e.g. rosters Conflict of Interest (COI) collection/renewals credentialing as required).
• Maintain detailed timelines and checklists to ensure seamless execution of safety committee operations and deliverables such as meeting summaries.

• Provide direct support and subject matter expertise to team members customers and external stakeholders.
• Serve as a reliable coordination point for DSMB Chairs/members study teams and internal stakeholders to align timelines deliverables and expectations.
• Communicate professionally document decisions clearly and ensure requests are triaged tracked and resolved appropriately.

• Create user-friendly training materials (internal and external stakeholders) and quick-reference guides for DSMB procedures workflows templates and system processes.
• Support onboarding of new team members by documenting standard work and assisting with process training and adoption.

• Bachelors degree in life sciences public health regulatory affairs or related field (or equivalent experience).
• 5 years of experience in clinical research operations safety committee support clinical trial logistics or regulatory documentation.
• 2 years of direct DSMB experience (coordination documentation meeting support).
• Demonstrated ability to author and maintain procedures aligned with program client government policies and industry standards (e.g. SOPs work instructions checklists templates and process maps).
• Strong working knowledge of regulated documentation practices including version control controlled records and audit readiness.
• Exceptional written and verbal communication skills with the ability to produce clear structured regulator-ready documentation.
• Strong attention to detail organization and ability to manage multiple deadlines in parallel.

• Experience in NIH or other federal clinical research environments.
• Experience using electronic document management / DSMB management systems (e.g. document routing permissions versioning).
• Familiarity with applicable expectations and standards (e.g. ICH-GCP and relevant FDA/OHRP/HHS requirements).

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 The decision on granting reasonable accommodation will be made on a case-by-case basis.