Remote Study Training & DOA Compliance Lead

Care Access; Boston (MA); Remote; USD 60,000 - 80,000; Full time

Benefits offered by this job

PTO

Company paid holidays

Health insurance

Health Savings Account

Job summary

Care Access in the United States is seeking a Senior Specialist to manage study training compliance and DOA matrix workflows within the Central Support Operations team. You will coordinate training records, ensure ICH-GCP and sponsor requirements, and support audits with cross-functional partners across multiple studies.

The role emphasizes meticulous documentation, familiarity with Florence eISF and CTMS, and proactive collaboration to keep training and DOA readiness on track in a regulated

Qualifications

• 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.

Responsibilities

• 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.
• Lead coordination of DOA matrix setup, review, and updates in alignment with protocol milestones.
• Upload, maintain, and review essential staff training records and certificates within the electronic Investigator Site File (eISF) and other internal systems.

Skills

Clinical research operations

Training documentation

Regulatory environment

Attention to detail

Cross-functional collaboration

Microsoft Office

Education

Bachelor’s degree in Life Sciences

Tools

Florence eISF

CTMS

Sponsor portals

Job description

Care Access in the United States is seeking a Senior Specialist to manage study training compliance and DOA matrix workflows within the Central Support Operations team. You will coordinate training records, ensure ICH-GCP and sponsor requirements, and support audits with cross-functional partners across multiple studies.

The role emphasizes meticulous documentation, familiarity with Florence eISF and CTMS, and proactive collaboration to keep training and DOA readiness on track in a regulated