Remote Senior Clinical Research Associate – Global Trials

Puma Biotechnology Inc; United States; Remote; USD 99,000 - 165,000; Full time

Job summary

Puma Biotechnology Inc. is seeking a Senior Clinical Research Associate (Remote). The role serves as the primary liaison between Puma and allocated investigative sites to ensure trials run on time and within budget, while complying with ICH GCP and SOPs.

This remote position requires strong site communication, monitoring, and regulatory expertise. Responsibilities include overseeing site performance, preparing documents, ensuring audit readiness, and collaborating with cross-functional teams.

Qualifications

• Bachelor’s degree or equivalent in science/health field
• Min. five years health-related experience including CRA
• Strong understanding of ICH GCP and FDA regulatory knowledge
• Global trial experience preferred
• Previous field monitoring experience preferred

Responsibilities

• Maintains ongoing communication with sites to respond to questions and resolve issues
• Facilitates preparation and collection of site-level documents
• Assesses site performance and training to ensure protocol and regulatory compliance
• Develops and maintains relationships with site investigators and staff
• Assists with audit/inspection readiness and responses
• Escalates site issues and collaborates to resolve them
• Participates in study team meetings and supports study conduct

Skills

Site communication

Study monitoring

ICH GCP knowledge

Regulatory knowledge

Education

Bachelor’s degree or equivalent combination of education/experience in science/health

Tools

EDC systems

Job description

Puma Biotechnology Inc. is seeking a Senior Clinical Research Associate (Remote). The role serves as the primary liaison between Puma and allocated investigative sites to ensure trials run on time and within budget, while complying with ICH GCP and SOPs.

This remote position requires strong site communication, monitoring, and regulatory expertise. Responsibilities include overseeing site performance, preparing documents, ensuring audit readiness, and collaborating with cross-functional teams.