Senior Regulatory Coordinator

Senior Regulatory Coordinator

Location

Los Angeles, CA

Contract Details

• Position Type: Contract
• Duration: 13 weeks
• Pay Rate: $30 - $35/Hr
• Work Authorization: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
• Shift: Day (5x8 Hours) 8:00 17:00

Job Summary

This is a Senior Regulatory Coordinator position in the clinical research field.

Key Responsibilities

The Senior Regulatory Coordinator will be responsible for:

• Preparing and submitting regulatory documentation to Institutional Review Boards (IRB) and study sponsors
• Submitting continuations and amendments to regulatory bodies
• Tracking and maintaining regulatory documents, including lab certifications, CVs, IRB compliance documentation, correspondence letters, medical licenses, FDA Forms, Delegation of Authority Forms, and Serious Adverse Event submissions
• Ensuring compliance with FDA Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) requirements
• Ensuring compliance with Local Institutional Review Board (IRB) regulatory requirements
• Reviewing informed consent forms to ensure compliance with applicable laws and institutional policies
• Working with applicable regulations, institutional policies, Standard Operating Procedures (SOPs), and study-specific protocols, plans, and processes

Required Qualifications

• Bachelor's degree
• 3 years in the field of clinical research
• 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, CVs, 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 year oncology experience
• CCRP certification
• Epic Experience

About GTT

GTT is a minority-owned staffing firm and a subsidiary of Chenega Corporation, a Native American-owned company in Alaska. As a Native American-owned, economically disadvantaged corporation, we highly value diverse and inclusive workplaces. Our clients are Fortune 500 banking, insurance, financial services, and technology companies, along with some of the nation's largest life sciences, biotech, utility, and retail companies across the US and Canada. We look forward to helping you land your next great career opportunity!

Job Number

26-03765