Senior Clinical Research Associate

Responsibilities:

• Proactively identifying and documenting site level risks and issues, responding to study specific questions, and managing escalations through to resolution.

• Overseeing the collection, review, and maintenance of essential regulatory and study documents to ensure inspection readiness.

• Managing day-to-day communication with assigned sites, supporting enrollment, query resolution, and overall site performance.

Requirements:

• Possessing a Bachelor's degree in a life sciences or health-related field.

• Having 5+ years of clinical trial experience to include study monitoring

• Demonstrating strong knowledge of FDA regulations, ICH-GCP guidelines, and clinical trial operations.

Nice to have:

• Showing proficiency in Microsoft Office and clinical trial management systems (CTMS) preferred.

• CCRA/CCRP certification.

• Ability to travel frequently, sometimes on short notice, and manage travel logistics effectively.