Research Regulatory Coordinator
Core
Oversees regulatory affairs for researchers at Arkansas Children's Research Institute, ensuring human subjects research protocols comply with federal regulations, state codes, and IRB standards.
Role type
Regulatory Clinical Research Coordinator
Builds
Regulatory compliance for clinical research studies
Domain
Healthcare / Clinical Research
Deliverable
client delivery
Required skills
IRB document preparation, regulatory form review, study initiation coordination, compliance monitoring, sponsor communication, contract negotiation
Preferred skills
CCRP certification, Bachelor's degree in related field, 2+ years experience
Technologies
Regulatory binders, IRB systems
Responsibilities
Prepare and submit IRB documents and regulatory forms to sponsors; Review start-up regulatory documentation for accuracy; Coordinate pre-site and interim monitoring visits; Manage and proofread study regulatory drafts; Communicate review board decisions and compliance issues to research teams; Negotiate revisions with researchers and sponsors for regulatory approval.
Seniority
Individual Contributor, operational support