Regulatory Audit Coordinator (Fully Remote)

COG Research Foundation, LLC; United States; À distance; USD 65 000 - 90 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

FDA regulations knowledge

ICH-GCP familiarity

Regulatory audits

Formation

Bachelor's degree or equivalent

Description du poste

• 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.