Regulatory Specialist II (Oncology)
Core
Ensuring research studies maintain accurate and up-to-date regulatory files and serving as a central resource for faculty conducting clinical research.
Role type
Regulatory Specialist II (Clinical Research)
Builds
Regulatory documentation and compliance for clinical trials
Domain
Academic medical research / Oncology
Deliverable
client delivery
Required skills
Regulatory document preparation, IRB submission management, SOP development, audit support, adverse event reporting, protocol tracking
Preferred skills
Experience with coordinating center functions, process improvement
Technologies
Electronic regulatory binders, IRB systems
Responsibilities
Collaborate with Research Nurses and Principal Investigators for IRB submissions, oversee clinical trial implementation from conception to activation, collect regulatory documents from participating sites, prepare and manage regulatory forms (FDA Form 1572, financial disclosures), maintain organized regulatory binders, report serious adverse events and protocol deviations, track protocol submissions and identify bottlenecks, participate in study start-up meetings and monitoring visits, assist with regulatory inspections and audits
Seniority
Mid-level individual contributor