Clin Rsearch Reg Spt Spc II
Core
Lead auditor and regulatory support specialist ensuring compliance of a national network of 800+ community oncology practices with federal regulations and Good Clinical Practice guidelines for a $40M NIH-funded cancer control research program.
Role type
Senior Clinical Research Regulatory Support Specialist (Auditor)
Builds
Compliance assurance for multi-site Phase II–III randomized clinical trials in cancer care delivery
Domain
Healthcare / Clinical Research / Oncology
Required skills
Auditing, Quality Assurance, Regulatory Compliance, GCP knowledge, Protocol management, Data integrity, SOP development, Training material creation, MS Office proficiency
Preferred skills
Clinical trial monitoring experience, Medical terminology, Leadership, Independent work, Stakeholder collaboration, English fluency, ACRP/SOCRA certification
Technologies
MS Office (Word, Excel, PowerPoint), NCI drug accountability logs, IRB systems
Responsibilities
Establish and lead remote/in-person audits of off-site affiliates; Verify regulatory documentation, informed consent, pharmacy operations, and source data; Prepare SOPs, training materials, and audit checklists; Act as backup for Data Safety Coordinator and Regulatory Specialists; Submit protocol amendments and reportable events to NCI/IRB
Seniority
Senior, hands-on IC with leadership responsibilities
