Quality Assurance and Research Education Coordinator
On-site · Wilmington, Delaware, United States
Job Summary
Quality Assurance and Research Education Coordinator oversees compliance with FDA/ICH-GCP, develops and writes monitoring plans, conducts on-site and remote monitoring, performs data verification against source documents, coordinates monitoring assignments, prepares monitoring reports, supports audit readiness, and provides education and training for clinical research staff; travel up to 30% to support monitoring and education activities; requires Certified Clinical Coordinator through SOCRA or ACRP, Bachelor’s degree, and minimum 3 years’ regulatory experience.
Required Qualifications
- Certified Clinical Coordinator either through SOCRA or ACRP required
- Bachelor's degree required
- A minimum of 3 years of relevant experience required
- Experience dealing with regulatory agencies required
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