Safety Committee Specialist, DSMB and Documentation

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 program’s 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 Operating Procedures (SOPs), work instructions, checklists, templates, and process maps that enable consistent, scalable operations.

• 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 project’s 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.

• Bachelor’s degree in life sciences, public health, regulatory affairs, or related field (or equivalent experience).
• 5+ years of experience in clinical research…