Senior Specialist, Study Training Compliance & DoA Matrix Management
New
J
JobgetherClinical research
Fully remote work within the United StatesFull-TimeSenior
Salary60,000 - 80,000 USD per year
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Job Details
- Experience
- Three to five years of experience in central support, clinical operations, clinical research compliance, or a related function
- Required Skills
- Microsoft Excel
Requirements
- Three to five years of experience in central support, clinical operations, clinical research compliance, or a related function.
- Experience supporting or leading training compliance workflows, DoA matrix coordination, and documentation management across multiple clinical studies.
- Strong understanding of clinical research operations, training documentation, regulatory requirements, and quality-driven processes.
- Familiarity with ICH-GCP principles, SOPs, sponsor requirements, and maintaining audit-ready clinical trial documentation.
- Experience with electronic Investigator Site File (eISF) platforms; Florence experience is particularly preferred.
- Familiarity with Clinical Trial Management Systems (CTMS), Clinical Conductor, sponsor portals, and other training or compliance systems is strongly preferred.
- Proficiency in Microsoft Excel, Word, Outlook, and SharePoint, as well as compliance tracking databases and tools.
- Strong organizational, planning, and tracking skills, with attention to detail and documentation accuracy.
- Ability to manage multiple complex assignments independently, prioritize deadlines, identify compliance gaps, and resolve issues proactively.
- Bachelor's degree in Life Sciences, Health Administration, Clinical Research, or a related field preferred.
Responsibilities
- Monitor and coordinate training completion across clinical studies in line with study-specific requirements, ICH-GCP, SOPs, and sponsor documentation standards.
- Verify training accuracy and suitability for assigned roles during study start-up, transitions, and key study milestones.
- Maintain accurate, current training records and certificates in eISF platforms and other internal systems.
- Coordinate the creation, review, approval, and updating of DoA matrices according to protocol requirements and study timelines.
- Check that training status and staff roles align with delegated study responsibilities, and identify and escalate gaps before study activation.
- Prepare documentation for audits and respond to document requests, inspections, and monitoring visits.
- Provide guidance to internal teams and site staff on training compliance and delegation documentation requirements and deadlines.
- Coordinate compliance activities with clinical operations teams, sponsors, vendors, and other stakeholders.
- Contribute to study-specific training plans, compliance trackers, standardized tools, guidance materials, and internal SOPs.
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