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Position Summary:
- The Regulatory Audit Coordinator conducts regulatory audits of COG institutions per NCI CTMB guidelines, reviewing IRB submissions and informed consent documents for compliance.
- This role also manages regulatory document review for industry-funded studies and protocol deviation forms.
Essential Duties and 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.
Qualifications:
- Minimum two years experience as a Clinical Regulatory Coordinator, Auditor, or Monitor with knowledge of FDA regulations and ICH-GCP.
- Bachelor's degree in a relevant field or equivalent experience; oncology clinical trials experience preferred.
COG Research Foundation, LLC
COG Research Foundation, LLC is a California 501(c)(3) entity founded in 2024 to serve as a fiscal sponsor for the Children's Oncology Group (COG), providing legal, fiduciary, and administrative oversight for childhood cancer research. The organization unites over 13,500 experts at more than 220 leading hospitals and cancer centers worldwide, fostering a collaborative and mission-driven culture focused on improving outcomes for children with cancer.