Senior Regulatory Coordinator (Los Angeles)
Senior Regulatory Coordinator
Location: Los Angeles
- 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.
Preferred Qualifications:
• 1+ years oncology experience
• CCRP certification
• Epic Experience
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