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Administrative Regulatory Coordinator
The Administrative Coordinator provides centralized administrative, coordination, documentation, and operational support within the Regulatory Affairs department at DM Clinical Research. This role supports regulatory leadership and cross-functional stakeholders by coordinating internal training activities, maintaining documentation and trackers, supporting meetings and leadership initiatives, and executing projects as directed by management.
DUTIES & RESPONSIBILITIES
- Complete all DMCR-required training, including GCP, and maintain a working knowledge of applicable FDA regulations, GCP ICH guidelines, organizational SOPs, guidance documents, and study protocols as relevant to assigned tasks
- Provide centralized administrative and operational support to Regulatory Affairs leadership and assigned stakeholders
- Coordinate internal regulatory training activities, including onboarding, refresher sessions, and role-based trainings, and maintain training calendars, attendance logs, completion trackers, and documentation
- Support the development, maintenance, organization, and version control of regulatory templates, trackers, logs, dashboards, and operational tools
- Perform administrative tasks including document preparation, formatting, organization, filing, correspondence, and presentation support
- Schedule and coordinate regulatory and cross functional meetings, prepare agendas, capture meeting minutes, track action items, and support follow up on assigned deliverables
- Manage CVs, credentials, certifications, and administrative documentation for investigators, regulatory staff, and leadership, including tracking updates and expirations
- Support Regulatory management with metric gathering, data consolidation, and reporting support
- Provide coordination and administrative support for regulatory leadership initiatives, priority workstreams, and time sensitive or high priority initiatives
- Provide operational coverage during periods of increased workload or resource gaps and support onboarding and training of new regulatory administrative staff as assigned
- Execute ad hoc and catchall projects as directed by Regulatory management, including one off documentation support, coordination efforts, summaries, and special projects
- Perform any other duties as assigned by Regulatory leadership in support of departmental and organizational needs
KNOWLEDGE & EXPERIENCE
Education:
- High school diploma required, Bachelor’s degree preferred
- 1–2 years of experience with spreadsheets, trackers, or data organization
- 1–2 years of experience using Google Workspace or Microsoft Office products
- 1–2 years of experience with meeting support, minute-taking, coordination, or administrative documentation
- N/A
- Strong organizational and time management skills
- Professional written and verbal communication skills
- Ability to manage multiple priorities under management direction
- High attention to detail and follow-through
- Strong computer proficiency
- Discretion and professionalism when supporting Regulatory leadership
- Ability to work independently with minimal supervision
- Typing speed of at least 40 words per minute
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