Senior Specialist, Study Training Compliance & DoA Matrix Management

Overview

Senior Specialist for Study Training Compliance and Delegation of Authority (DOA) matrix management within Care Access's Central Support Operations team, overseeing training compliance and delegation documentation across clinical research studies.

What you'll do

• Monitor and manage clinical staff training completion across multiple studies, ensuring alignment with study-specific and mandatory compliance requirements.
• Verify training accuracy and appropriateness for assigned roles during study start-up and transition phases.
• Ensure training records are consistently 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 coordination of DOA matrix setup, review, and updates in alignment with protocol milestones.
• Confirm training compliance and role alignment for delegated tasks; flag gaps for resolution before study activation.
• Serve as a point of contact for delegation matrix-related documentation during audits and monitoring visits.
• Upload, maintain, and review essential staff training records and certificates within the electronic Investigator Site File (eISF) and other internal systems.
• Ensure audit-readiness of all training and delegation matrix documentation across assigned studies.
• Prepare for and support internal audits, sponsor inspections, and document request responses related to study training compliance.
• Collaborate with clinical teams and other internal stakeholders to ensure training and delegation readiness across all phases of study execution.
• Contribute to study-specific training plans and compliance tracking tools to improve visibility and standardization.
• Communicate proactively with internal staff, sponsors, and vendors to support compliance activities and escalate issues when necessary.
• Participate in meetings and provide subject matter input on training and DOA compliance operations.
• Identify and contribute to process improvement opportunities related to training workflows and delegation management.
• Assist with the creation and refinement of guidance materials, trackers, and internal SOPs.
• Perform other duties as assigned.

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.
• 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.
• Minimum education: Bachelor's degree in Life Sciences, Health Administration, Clinical Research, or a related field.

Nice to have

• Bachelor's degree in Life Sciences, Health Administration, Clinical Research, or a related field (education listed as preferred under Minimum Education).
• Familiarity with eISF systems (Florence), CTMS tools, and sponsor portals.

Details

• Location: Remote within the United States; 100% of work performed in a remote office environment.
• Travel: Less than 10% travel; occasional planned travel may be required.
• Physical demands: ability to use keyboards and other computer equipment.
• Pay range: $60,000 - $80,000 USD per year for full-time team members.
• Care Access is unable to sponsor work visas at this time.