Position Overview:We are seeking a Safety Committee Specialist (SCS) with a strong interest in clinical trial safety, regulatory compliance, and the coordination of Data and Safety Monitoring Boards (DSMBs). This role will play a critical part in both ensuring regulatory alignment and overseeing the detailed coordination and logistics needed to support DSMB operations for 30 DSMBs within an electronic management system.
Reporting to the Director of Clinical Research Solutions, this SCS 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 research quality.
Core Responsibilities:Regulatory & Compliance Execution
- Serve as the primary point of contact and subject matter expert for the DSMB portfolio.
- Assist in the implementation of DSMB-related Standard Operating Procedures (SOPs) and Working Practice Guidelines (WPGs) in accordance with GCP, FDA, EMA, ICH, and NIH standards.
- Maintain and manage accurate documentation for DSMB charters, rosters, COI forms, meeting minutes, decision letters, and regulatory correspondence.
- Support audits and quality checks related to DSMB activity and compliance status.
DSMB Leadership
- Serve as the primary representative for assigned DSMBs including internal and external stakeholders.
- Lead meeting logistics, including agenda coordination, calendar invitations, material distribution.
- Track and lead action items, meeting outcomes/outputs, and follow-up requests to ensure timely resolution.
- Coordinate onboarding and Conflict-of-Interest (COI) documentation for DSMB members and serve as a key point of contact for meeting logistics.
- Maintain detailed timelines, checklists, and communications to ensure seamless execution of DSMB operations.
- Interface with DSMB Chairs, members, study teams, the government client, and internal staff to align on logistics, timelines, and expectations.
- Respond to inquiries related to DSMB coordination, SOPs, and documentation requirements.
Operational Support
- Maintain meticulous, system-driven records in the electronic DSMB management system, ensuring traceability, version control, and real-time visibility of safety committee operations.
- Prepare routine reports for internal and external stakeholders on DSMB progress, meeting schedules, member status, and compliance metrics.
- Identify, escalate and provide potential solutions to risks and opportunities related to safety committee operations.
- Translate strategic direction into action by proactively managing timelines, refining documentation workflows, and flagging risks or process gaps to leadership.
Training & Documentation
- Assist in the development of user-friendly training materials, guidance documents, and process maps.
- Participate in team meetings and training efforts as well as contribute to onboarding new team members to DSMB workflows and logistics.
Required Qualifications:- Bachelor's degree in life sciences, biotechnology, medical science, or a related field (or equivalent experience).
- 5+ years of clinical research experience and/or clinical research related logistics.
- 2+ years of direct DSMB experience (coordination, documentation, meeting support).
- 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.
- Strong sense of ownership, responsibility, and teamwork.
- Proven ability to manage complex timelines, coordinate logistics, and align multiple stakeholders to drive forward critical safety committee milestones with precision and efficiency.
- A resilient, team-first approach fueled by curiosity and a drive to continually improve processes in service of advancing clinical research and patient safety.
