Remote Regulatory Audit Coordinator for Oncology Trials

COG Research Foundation, LLC; Polska; Híbrido; PLN 275.000 - 399.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical insurance

Dental insurance

Vision insurance

401(k) plan

Paid time off

Descripción de la vacante

COG Research Foundation, LLC is seeking a Regulatory Audit Coordinator to manage regulatory components of COG audits and ensure compliance with federal regulations and COG policies. The role includes reviewing IRB submissions and consent documents to align with the COG template and SOPs.

The position requires strong attention to detail, experience with oncology trials, and ability to interact with sites, reviewers, and regulators while traveling as needed.

Formación

• Experience reviewing IRB submissions and consent forms for compliance.
• Knowledge of FDA regulations and ICH-GCP guidelines.
• Ability to analyze protocols and regulatory documents for findings.

Responsabilidades

• Conduct regulatory reviews for IRB submissions and ICC content.
• Translate findings into draft audit reports for sites and auditors.
• Manage regulatory audit summaries and track corrective actions.
• Coordinate with NCI CIRB and other regulators as needed.
• Review protocol deviations and early closure forms for compliance.

Conocimientos

Regulatory audits

IRB submissions

FDA regulations

ICH guidelines

Regulatory reporting

Educación

Bachelor’s degree in biology or related field

Herramientas

Medidata Rave

Descripción del empleo

COG Research Foundation, LLC is seeking a Regulatory Audit Coordinator to manage regulatory components of COG audits and ensure compliance with federal regulations and COG policies. The role includes reviewing IRB submissions and consent documents to align with the COG template and SOPs.

The position requires strong attention to detail, experience with oncology trials, and ability to interact with sites, reviewers, and regulators while traveling as needed.