Senior Specialist, Study Training Compliance & DoA Matrix Management
Core
Oversees coordination and execution of training compliance and delegation documentation across a portfolio of clinical research studies, ensuring alignment with regulatory standards and sponsor expectations.
Role type
Senior Specialist, Clinical Research Operations (Compliance & Documentation)
Builds
Audit-ready training records and Delegation of Authority (DOA) matrices for clinical studies
Domain
Clinical Research / Healthcare
Required skills
Clinical research operations, training compliance workflows, DOA matrix coordination, eISF system management, audit preparation, process improvement, Microsoft Office proficiency, documentation accuracy
Preferred skills
Experience with CTMS tools, sponsor portals, Florence (eISF), Life Sciences background (via careerplan.io/jobs/4438639009-senior-specialist-study-training-compliance-doa-matrix-management-at-careaccess)
Technologies
Florence (eISF), Clinical Conductor, Microsoft Office (Excel, Word, Outlook, SharePoint), CTMS
Responsibilities
Monitor and manage clinical staff training completion across multiple studies; Verify training accuracy and appropriateness for assigned roles; Lead coordination of DOA matrix setup, review, and updates; Upload and maintain staff training records in eISF; Prepare for and support internal audits and sponsor inspections; Collaborate with clinical teams to ensure training and delegation readiness
Seniority
Senior, hands-on IC