Senior Clinical Trials Operations Lead

Astera Cancer Care; Northern (KY); Hybrid; USD 85,000 - 110,000; Full time

Job summary

OneOncology is seeking a Senior Study Operations Specialist to support clinical study execution, enrollment, and prescreening within a physician-led, technology-powered network. You will coordinate with investigators, coordinators, and clinical teams to ensure GCP and regulatory compliance and drive efficient study conduct.

The role emphasizes patient recruitment, data accuracy in EMR/CTMS, and collaboration across cross-functional teams to improve cancer care access and outcomes.

Qualifications

• 5+ years of clinical research or oncology experience.
• Bachelor's degree in nursing, life sciences, or related field.
• Advanced degree preferred (e.g., MSN, RN, NP) or commensurate experience.

Responsibilities

• Coordinate enrollment, follow-up, and study close-out.
• Ensure studies comply with GCP, ICH, and local regulations.
• Lead patient recruitment and prescreening activities.
• Document data accurately in EMR/CTMS and collaborate with PI teams.

Skills

GCP/ICH

Clinical research

Communication

Cross-functional teamwork

Regulatory knowledge

Education

Bachelor's degree in nursing, life sciences, or related field

Advanced degree preferred (MSN, RN, NP, etc.)

Tools

EDC systems

CTMS

Job description

OneOncology is seeking a Senior Study Operations Specialist to support clinical study execution, enrollment, and prescreening within a physician-led, technology-powered network. You will coordinate with investigators, coordinators, and clinical teams to ensure GCP and regulatory compliance and drive efficient study conduct.

The role emphasizes patient recruitment, data accuracy in EMR/CTMS, and collaboration across cross-functional teams to improve cancer care access and outcomes.