Senior Specialist, Study Training Compliance – DoA Matrix Management

CARE

. Monitor and manage clinical staff training completion across multiple studies .

Posted 10/8/2026full-timeRemote • United StatesSenior💰 $60,000 - $80,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical research operations, training documentation, and regulatory compliance, with a strong focus on maintaining audit-ready documentation and effective communication across teams. Proficient in managing training workflows and delegation of authority matrices within a fast-paced research environment.

Highest-signal resume keywords

Clinical Research OperationsTraining Documentation ManagementRegulatory ComplianceDelegation of Authority (DOA) CoordinationAudit-Ready Documentation

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Training Compliance WorkflowsDocumentation ManagementProcess ImprovementAttention to DetailOrganizational Skills

Soft Skills

Excellent CommunicationInterpersonal SkillsCoordination Skills

Tools & Technologies

Florence (eISF)Clinical ConductorMicrosoft Office (Excel, Word, Outlook, SharePoint)Compliance Tracking Databases

Industry Keywords

ICH-GCPSOPsClinical TrialsCentral SupportClinical Research Compliance

About the role

Key responsibilities & impact

Monitor and manage clinical staff training completion across multiple studies
Verify training accuracy and appropriateness for assigned roles during study start-up and transition phases
Ensure training records are complete, current, and compliant with ICH-GCP, SOPs, and sponsor documentation standards
Provide guidance to internal teams and site staff on training requirements and timelines
Lead Delegation of Authority (DOA) matrix setup, review, and updates in alignment with protocol milestones
Confirm training compliance and role alignment for delegated tasks and flag gaps before study activation
Serve as a point of contact for delegation matrix documentation during audits and monitoring visits
Upload, maintain, and review staff training records and certificates within the electronic Investigator Site File (eISF) and other internal systems
Ensure audit-readiness of training and delegation matrix documentation across assigned studies
Prepare for and support internal audits, sponsor inspections, and document request responses
Collaborate with clinical teams and internal stakeholders across all phases of study execution
Contribute to study-specific training plans and compliance tracking tools
Communicate with internal staff, sponsors, and vendors to support compliance activities and escalate issues
Participate in meetings and provide subject matter input on training and DOA compliance operations
Identify process improvement opportunities related to training workflows and delegation management
Assist with guidance materials, trackers, and internal SOPs
Perform other duties as assigned

Requirements

What you’ll need

Strong understanding of clinical research operations, training documentation, and the regulatory environment
Advanced organizational and tracking skills with attention to detail and documentation accuracy
Ability to manage multiple complex assignments with minimal oversight while meeting deadlines in a fast-paced setting
Comfortable navigating and maintaining documentation across platforms such as Florence (eISF), Clinical Conductor, and other training systems
Excellent communication and interpersonal skills; able to coordinate effectively with internal teams, site staff, vendors, and sponsors
Skilled in identifying and addressing gaps in training documentation or delegation readiness
Proficient in Microsoft Office (Excel, Word, Outlook, SharePoint); experience with compliance tracking databases and tools
Bachelor's degree in Life Sciences, Health Administration, Clinical Research, or a related field preferred
Minimum of 3–5 years of experience in a Central Support, Clinical Operations, or Clinical Research Compliance role, ideally within a regulated research environment
Proven success supporting or leading training compliance workflows, DOA matrix coordination, and documentation management across multiple clinical studies
Demonstrated ability to work within quality-driven systems and maintain audit-ready documentation across multiple trials
Familiarity with eISF systems (Florence), CTMS tools, and sponsor portals is strongly preferred
Must be able to work remotely within the United States
Care Access is unable to sponsor work visas at this time

Benefits

Comp & perks

Paid Time Off (PTO) and Company Paid Holidays
100% Employer paid medical, dental, and vision insurance plan options
Health Savings Account and Flexible Spending Accounts
Bi-weekly HSA employer contribution
Company paid Short-Term Disability and Long-Term Disability
401(k) Retirement Plan, with Company Match