Clinical Research Regulatory Specialist
Core
Ensure regulatory compliance for multi-center Alzheimer's disease clinical trials from study start-up through closure.
Role type
Clinical Research Regulatory Specialist
Builds
Investigator Initiation Packages (IIPs), IRB submissions, and Essential Site Regulatory Documents for ATRI clinical trials.
Domain
Biopharmaceuticals / Clinical Research / Alzheimer's Disease
Required skills
Regulatory compliance (FDA, GCP, OHRP), eTMF systems, IRB submission management, document review and tracking, protocol consistency review, risk evaluation, policy interpretation
Preferred skills
Clinical research compliance oversight, coordination, monitoring, and auditing of trials, advanced knowledge of human research regulations
Technologies
eTMF systems, Microsoft Office, Google Drive
Responsibilities
Review site-specific informed consent forms for consistency with protocols and regulations; Prepare Investigator Initiation Packages (IIPs); Initiate IRB submissions via USC iStar and Advarra; Track study start-up activities and provide updates; Distribute and process Essential Site Regulatory Documents; Upload essential documents into electronic Trial Master File (eTMF) systems
