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.
