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Clinical Research Regulatory Associate

Company

Actalent

Location

Detroit, United States

Type

Full-time

Job Title: Clinical Research Regulatory Associate – Oncology
The Regulatory Associate supports oncology clinical research by managing regulatory maintenance activities for approximately 30 phase II–IV clinical trials. This role focuses on preparing and submitting regulatory documents, coordinating IRB submissions, maintaining study records, and ensuring monitors and study teams have appropriate system access. The Regulatory Associate works closely with Clinical Research Coordinators and Data Coordinators to ensure regulatory compliance, data integrity, and smooth study operations in a collaborative and growth-oriented environment.
Responsibilities

+ Support all regulatory maintenance activities for oncology clinical trials within the Thoracic disease group, including managing documentation for approximately 30 phase II–IV studies.

+ Prepare, submit, and track IRB submissions to both local and central IRBs, including Advarra and WCG, ensuring accuracy, completen...

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