Senior Specialist, Study Training Compliance & DoA Matrix Management
New
C
Care AccessClinical research
Remote within the United States.Full-TimeSenior
Salary60,000 - 80,000 USD per year
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Job Details
- Experience
- Minimum of 3–5 years of experience in a Central Support, Clinical Operations, or Clinical Research Compliance role, ideally within a regulated research environment.
- Required Skills
- SharePointMicrosoft Excel
Requirements
- Minimum of 3–5 years of experience in a Central Support, Clinical Operations, or Clinical Research Compliance role, ideally in a regulated research environment.
- Strong understanding of clinical research operations, training documentation, and the regulatory environment.
- Proven experience supporting or leading training compliance workflows, DOA matrix coordination, and documentation management across multiple clinical studies.
- Demonstrated ability to maintain audit-ready documentation across multiple trials and work within quality-driven systems.
- Comfort navigating and maintaining documentation in Florence eISF, Clinical Conductor, and other training systems.
- Familiarity with eISF systems, CTMS tools, and sponsor portals is strongly preferred.
- Proficiency in Microsoft Office, including Excel, Word, Outlook, and SharePoint.
- Experience with compliance tracking databases and tools.
- Strong organizational and tracking skills, with attention to detail and documentation accuracy.
- Ability to manage multiple complex assignments with minimal oversight and meet deadlines.
Responsibilities
- Monitor clinical staff training completion across multiple studies and verify training accuracy for assigned roles.
- Maintain complete, current training records aligned with ICH-GCP, SOPs, and sponsor documentation standards.
- Coordinate the setup, review, and updates of DOA matrices in line with protocol milestones.
- Confirm training compliance and role alignment for delegated tasks, and flag gaps before study activation.
- Upload, maintain, and review staff training records and certificates in Florence eISF and other internal systems.
- Prepare for and support internal audits, sponsor inspections, and document requests related to training compliance.
- Collaborate with clinical teams, site staff, sponsors, and vendors to support training and delegation readiness.
- Contribute to training plans, compliance tracking tools, guidance materials, trackers, and internal SOPs.
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