Senior Specialist, Study Training Compliance & DoA Matrix Management

📋 Description

• Monitor and coordinate training completion across multiple clinical studies, ensuring compliance
• Verify training accuracy and suitability for assigned roles during study start-up, transitions, and
• Maintain complete, accurate, and up-to-date training records and certificates within electronic
• Coordinate the creation, review, approval, and ongoing updates of Delegation of Authority (DoA)
• Confirm that training status and staff roles align with delegated study responsibilities
• Support audit readiness by preparing documentation, responding to document requests, and assisting

🎯 Requirements

• Bachelor's degree in Life Sciences, Health Administration, Clinical Research, or a related field
• Three to five years of experience in central support, clinical operations, clinical research
• Demonstrated experience supporting or leading training compliance workflows, DoA matrix
• Strong understanding of clinical research operations, training documentation, regulatory
• Familiarity with ICH-GCP principles, SOPs, sponsor requirements, and maintaining audit-ready
• Experience with electronic Investigator Site File (eISF) platforms, particularly Florence, Clinical

🎁 Benefits

• Salary: $60,000–$80,000 USD per year for full-time team members.
• Remote flexibility: Fully remote work within the United States, with less than 10% travel expected
• Paid time off: Paid time off (PTO) and company-paid holidays.
• Healthcare coverage: Medical, dental, and vision insurance plan options with 100% of premiums paid
• Health savings options: Health Savings Account (HSA) and Flexible Spending Account (FSA) options
• Disability coverage: Company-paid short-term and long-term disability insurance.