Senior Specialist, Study Training Compliance & DoA Matrix Management

Accountabilities Monitor and coordinate training completion across multiple clinical studies, ensuring compliance with study-specific requirements, ICH-GCP, standard operating procedures (SOPs), and sponsor documentation standards.

Verify training accuracy and suitability for assigned roles during study start-up, transitions, and other key study milestones.

Maintain complete, accurate, and up-to-date training records and certificates within electronic Investigator Site File (eISF) platforms and other internal systems.

Coordinate the creation, review, approval, and ongoing updates of Delegation of Authority (DoA) matrices in line with protocol requirements and study timelines.

Confirm that training status and staff roles align with delegated study responsibilities, identifying and escalating gaps before study activation.

Support audit readiness by preparing documentation, responding to document requests, and assisting with internal audits, sponsor inspections, and monitoring visits.

Serve as a point of contact for training compliance and delegation documentation questions, providing guidance to internal teams and site staff on requirements and deadlines.

Partner with clinical operations teams, sponsors, vendors, and other stakeholders to coordinate compliance activities and resolve documentation challenges.

Contribute to study-specific training plans, compliance trackers, and standardized tools that improve visibility, consistency, and operational efficiency.

Identify process improvement opportunities and assist in developing and refining guidance materials, trackers, and internal SOPs.

Participate in meetings, share subject matter expertise, and perform additional duties as assigned.

Requirements:

Bachelor's degree in Life Sciences, Health Administration, Clinical Research, or a related field preferred.

Three to five years of experience in central support, clinical operations, clinical research compliance, or a related function, ideally within a regulated research environment.

Demonstrated 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 documentation across clinical trials.

Experience with electronic Investigator Site File (eISF) platforms, particularly Florence, Clinical Trial Management Systems (CTMS), Clinical Conductor, sponsor portals, and other training or compliance systems is strongly preferred.

Proficiency in Microsoft Office applications, including Excel, Word, Outlook, and SharePoint, as well as compliance tracking databases and tools.

Excellent organizational, planning, and tracking skills, with a high level of attention to detail and documentation accuracy.

Ability to manage multiple complex assignments independently, prioritize competing deadlines, identify compliance gaps, and resolve issues proactively.

Strong written and verbal communication skills, with the ability to collaborate effectively with internal teams, clinical site staff, sponsors, and vendors.

Comfortable working independently in a remote environment while contributing to cross-functional priorities and continuous process improvement.

Authorized to work in the United States without requiring current or future visa sponsorship.

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 and occasional planned trips.

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 by the employer.

Health savings options: Health Savings Account (HSA) and Flexible Spending Account (FSA) options, plus biweekly employer contributions to the HSA.

Disability coverage: Company-paid short-term and long-term disability insurance.

Retirement savings: 401(k) retirement plan with a company match.

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