Job TitleRequired Qualifications: Must be reflected on resume • Bachelor’s degree • 3+ years in the field of clinical research and as a Regulatory Coordinator/Specialist • Experience with applicable regulations, institutional policies, Standard Operating Procedures (SOPs), and study-specific protocols/plans and processes • Working knowledge of Institutional Review Board (IRB) & Contracts and Grants policies and procedures. • Experience in writing research correspondence to IRB and study sponsors. • Experience with submitting continuations and amendments to regulatory bodies.
• Experience tracking regulatory documents (including lab certifications, CV’s, IRB compliance and correspondence letters, medical licenses, FDA Forms, Delegation of Authority Forms, Serious Adverse Event submissions, etc.) • Experience with FDA Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) as well as Local Institutional Review Board (IRB) regulatory requirements. • Working knowledge of informed consent forms to ensure compliance with applicable laws and Institutional policies.