Job Description
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.
Bachelor’s degree
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.
Bachelor’s degree
💡 Quick Summary
Seeking a career-building opportunity? The Regulatory Affairs Coordinator position is now open for candidates interested in the Legal Jobs sector. This role in Los Angeles offers a professional environment and growth potential.
Requirement Snapshot: Candidates should possess basic communication skills, a proactive attitude, and the ability to work in a team. Experience in Legal Jobs is a plus.
