Clinical Research Regulatory Specialist
Core
Create, initiate, develop, and revise clinical research protocols, informed consents, and case report forms to support principal investigators and quality assurance systems.
Role type
Clinical Research Regulatory Specialist
Builds
Regulatory documentation, compliance reviews, and research project support for the Clinical Investigations Support Office
Domain
Academic clinical research and regulatory affairs
Required skills
Clinical research compliance, regulatory research operations, Institutional Review Board (IRB) submissions, FDA IND/IDE submissions, ICH-GCP knowledge, DHHS/OHRP/FDA regulations, risk evaluation, problem-solving, policy interpretation, instructional material development
Preferred skills
Compliance oversight, coordination, monitoring, and auditing of clinical trials, advanced knowledge of human research regulations
Technologies
Clinical trial management systems, IRB databases, Google Suite, Slack, Skype
Responsibilities
Submit protocols and supporting documents to internal and external regulatory bodies; manage and maintain electronic regulatory files; conduct compliance reviews including close-out and reporting; update databases and regulatory binders with milestone progress; coordinate with clinical trial coordinators, research staff, and investigators; identify compliance training needs and report serious adverse events and protocol deviations
Seniority
Mid-level, hands-on IC