Provides comprehensive regulatory coordination for clinical research studies, ensuring strict adherence to federal, state, sponsor, and institutional requirements
Job Summary
Provides comprehensive regulatory coordination for clinical research studies, ensuring strict adherence to federal, state, sponsor, and institutional requirements.
Prepares, submits, and maintains all required regulatory documentation for study start-up and ongoing compliance, including submissions to IRBs, FDA, and sponsors.
Serves as a liaison among investigators, sponsors, regulatory agencies, and study teams to ensure timely communication and compliance, focusing on regulatory aspects rather than patient care or data management.
Matching Summary
Provides comprehensive regulatory coordination for clinical research studies, ensuring strict adherence to federal, state, sponsor, and institutional requirements.
Salary
$31.51 - $62.64 Hourly
Skills & Requirements
Must-have
Regulatory coordination for clinical research
IRB and FDA submissions
Informed consent form drafting
Study activation project planning
Regulatory binder maintenance
Nice-to-have
Proactive application of evolving regulatory knowledge
Efficient study activation and oversight
High-volume clinical research environment experience
Key Requirements
1+ years of clinical researcher experience
Bachelor's degree or equivalent experience
Proficiency with Adobe and Microsoft suite
Working knowledge of clinical research regulations