Remote Regulatory Audit Coordinator — Oncology Compliance

COG Research Foundation, LLC; United States; Remote; USD 65,000 - 90,000; Full time

Job summary

COG Research Foundation, LLC is seeking a Regulatory Audit Coordinator to conduct regulatory audits of COG institutions per NCI CTMB guidelines, reviewing IRB submissions and informed consent documents for compliance. The role also manages regulatory document review for industry-funded studies and protocol deviation forms.

Essential duties include overseeing the audit program, reviewing IRB submissions, drafting audit reports, and distributing results to sites, along with managing protocol

Qualifications

• Minimum two years of experience as Clinical Regulatory Coordinator, Auditor, or Monitor.
• Knowledge of FDA regulations and ICH-GCP required.
• Oncology clinical trials experience preferred.

Responsibilities

• Oversee the COG audit program: review IRB submissions, record findings, draft audit reports, and distribute to sites.
• Manage protocol deviation intake: review forms, request CAPAs, and complete Lead Protocol Organization fields.
• Evaluate early closure requests and serve as primary regulatory contact for site inquiries.

Skills

FDA regulations knowledge

ICH-GCP familiarity

Regulatory audits

Education

Bachelor's degree or equivalent

Job description

COG Research Foundation, LLC is seeking a Regulatory Audit Coordinator to conduct regulatory audits of COG institutions per NCI CTMB guidelines, reviewing IRB submissions and informed consent documents for compliance. The role also manages regulatory document review for industry-funded studies and protocol deviation forms.

Essential duties include overseeing the audit program, reviewing IRB submissions, drafting audit reports, and distributing results to sites, along with managing protocol