Remote Regulatory Audit Coordinator for Oncology Trials

COG Research Foundation, LLC; Arcadia (CA); Remote; USD 70,000 - 102,000; Full time

Job summary

COG Research Foundation, LLC, a California nonprofit, seeks a Regulatory Audit Coordinator to conduct regulatory audits for COG institutions, reviewing IRB submissions and ensuring compliance with COG policies and federal regulations. This role emphasizes meticulous regulatory document review, coordination with QA leadership, and preparing audit reports while supporting site inquiries.

The position is 100% remote with some travel within the United States, offering a salary range noted in the

Qualifications

• Two years of experience in clinical regulatory coordination or related trials
• Strong knowledge of FDA regulations and ICH-GCP guidelines
• Ability to analyze protocols, consent forms, and regulatory submissions

Responsibilities

• Conduct regulatory reviews of IRB submissions and ICCs for audits
• Record findings and translate into draft audit reports for sites
• Distribute audit findings to sites and auditors per SOPs and timelines
• Review corrections and update regulatory summaries with QA leadership
• Travel to meetings and participate in regulatory discussions as needed

Skills

Regulatory compliance

Documentation review

FDA regulations

ICH guidelines

Audit coordination

Education

Bachelor's degree in biology/related field

Tools

Medidata Rave

Microsoft Office

Job description

COG Research Foundation, LLC, a California nonprofit, seeks a Regulatory Audit Coordinator to conduct regulatory audits for COG institutions, reviewing IRB submissions and ensuring compliance with COG policies and federal regulations. This role emphasizes meticulous regulatory document review, coordination with QA leadership, and preparing audit reports while supporting site inquiries.

The position is 100% remote with some travel within the United States, offering a salary range noted in the