Senior Field CRA: Monitoring & Site Leadership

Puma Biotechnology; Veterans Administration (CA); À distance; USD 140 000 - 165 000; Plein temps

Résumé du poste

Puma Biotechnology is seeking a Senior Clinical Research Associate (Sr. CRA) to serve as the primary liaison between the company and allocated investigative sites. You will monitor trials for timeliness and budget adherence while ensuring GCP/SOP compliance, train site staff, and support audits.

This remote role involves on-site travel; candidates should have 5+ years in health-related roles, including 3+ years as a CRA, and a strong FDA/GCP background.

Qualifications

• Bachelor's degree or equivalent in science/health field.
• Minimum five years health-related experience, including at least three years as a CRA.
• Strong understanding of ICH GCP and FDA regulatory requirements.

Responsabilités

• Act as central point of communication between Puma and investigation sites to ensure timely, compliant trials.
• Maintain site documentation and respond to questions or data queries promptly.
• Assess site performance and provide training to ensure protocol and regulatory compliance.
• Develop relationships with site investigators and staff; mentor less-experienced CRAs.
• Support audit readiness and respond to observations; escalate issues as needed.
• Participate in study team meetings and assist with budget and vendor management.

Connaissances

Communication

Organizational skills

Travel readiness

Problem solving

Independent work

Formation

Bachelor's degree in science/health

5+ years health-related experience (3+ in CRA)

Description du poste

Puma Biotechnology is seeking a Senior Clinical Research Associate (Sr. CRA) to serve as the primary liaison between the company and allocated investigative sites. You will monitor trials for timeliness and budget adherence while ensuring GCP/SOP compliance, train site staff, and support audits.

This remote role involves on-site travel; candidates should have 5+ years in health-related roles, including 3+ years as a CRA, and a strong FDA/GCP background.