Safety Committee Specialist, DSMB and Documentation

Digital Infuzion•Rockville, MD

About The Position

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: 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 Operation Procedures (SOPs), work instructions, checklists, templates, and process maps that enable consistent, scalable operations.

Requirements

Bachelor’s 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.

Nice To Haves

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).

Responsibilities

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.
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.