Impactful Oncology Regulatory Affairs Specialist

Sarah Cannon Research Institute; United States; À distance; USD 65 000 - 80 000; Plein temps

Résumé du poste

Sarah Cannon Research Institute (SCRI) seeks a Research Regulatory Affairs Specialist I to manage regulatory compliance for industry sponsors and sites within networks, working with regulatory affairs leads and principal investigators to ensure compliance and audit readiness.

Responsibilities include maintaining FDA and GCP documentation, updating consent forms, IRB submissions, handling protocol deviations, and coordinating safety communications.

Qualifications

• Associate’s Degree or higher is preferred; high school diploma required.
• 1+ year clinical research or regulatory affairs experience is highly desirable.
• Knowledge of FDA processes and regulatory requirements is preferred.

Responsabilités

• Establishes and maintains a document management system for regulatory electronic files
• Maintains FDA and GCP required regulatory documentation for sites, studies, sponsors and networks
• Ensures regulatory documentation is compliant with SOPs
• Modifies and updates informed consent forms and manages protocol amendments
• Organizes IRB submissions for multiple trials
• Processes Protocol Deviations and urgent safety notifications to the IRB
• Other duties as assigned

Formation

Associate’s Degree or higher

Description du poste

Sarah Cannon Research Institute (SCRI) seeks a Research Regulatory Affairs Specialist I to manage regulatory compliance for industry sponsors and sites within networks, working with regulatory affairs leads and principal investigators to ensure compliance and audit readiness.

Responsibilities include maintaining FDA and GCP documentation, updating consent forms, IRB submissions, handling protocol deviations, and coordinating safety communications.