Regulatory Specialist II (Cardiology)
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
Clinical trial operations and regulatory compliance for academic research studies
Domain
Academic Medicine / Clinical Research / Cardiology
Deliverable
client delivery
Required skills
Regulatory document preparation, IRB submission management, SOP development, audit support, adverse event reporting, protocol compliance tracking, data entry, stakeholder coordination
Preferred skills
Familiarity with NIH, GCP, OHRP, and federal regulations for human subject participation
Technologies
Study databases, electronic regulatory binders
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, maintain standard operating procedures, support auditing and monitoring activities, prepare and manage regulatory documentation including FDA Form 1572, ensure prompt reporting of serious adverse events, track protocol submissions through the IRB, attend study start-up meetings, participate in monitoring visits, assist in preparation for regulatory inspections, coordinate day-to-day clinical trial activities, support participant screening and enrollment, maintain accurate source documentation, facilitate communication among investigators and sponsors, prepare for sponsor monitoring visits and study close-out activities