Clinical Research Coordinator 2

A leading university is seeking a Clinical Research Coordinator 2 to independently manage clinical research activities and support oncology treatment studies. The role oversees study operations from participant recruitment through regulatory compliance, data management, and sponsor coordination.

Responsibilities

• Manage subject recruitment, enrollment, and retention activities, and oversee data collection systems, including organizing, monitoring, analyzing, and interpreting study data to support clinical research objectives
• Coordinate study operations by developing project schedules, leading team meetings, supervising and mentoring research staff or students, and supporting study budgets, milestone tracking, and sponsor invoicing activities
• Ensure regulatory compliance through oversight of Institutional Review Board submissions and renewals, FDA and Investigational New Drug application activities when applicable, study documentation reviews, audits, and implementation of corrective actions to maintain Good Clinical Practice standards
• Collaborate with principal investigators, sponsors, and research teams to monitor serious adverse events, resolve study queries, support protocol execution, and recommend process improvements and best practices
• Monitor study conduct and operational activities to ensure compliance with research protocols, HIPAA requirements, FDA regulations, and institutional policies while supporting continuous process improvements

Preferred

• CRO or pharmaceutical CRA-only backgrounds are not preferred

Benefits

• Group Medical
• Dental
• Vision
• Life
• Retirement Savings Program
• PSL
• Hybrid work in Palo Alto, CA

Company

• Workforce solutions for technology and healthcare companies
• Truckee, California, USA
• https://www.avispatechnology.com/
• Founded in 2011
• 51-200 employees

Qualifications

• 2+ years of clinical research experience or an equivalent combination of education and relevant experience
• Bachelor's degree in a related field
• Experience coordinating oncology treatment trials
• Experience supporting Phase I clinical trials
• Experience using EPIC electronic medical record systems
• Experience working onsite within a healthcare institution
• Knowledge of research protocols and regulatory requirements, including HIPAA, FDA regulations, Institutional Review Board requirements, and Good Clinical Practice guidelines
• Knowledge of medical terminology
• Proficiency with Microsoft Office applications and database systems
• CRO or pharmaceutical CRA-only backgrounds are not preferred
• 2+ years of clinical research experience or an equivalent combination of education and relevant experience.

Required skills

• Clinical Practice (GCP), Clinical Research, Clinical Research Protocols, EPIC, FDA Regulations, HIPAA, Institutional Review Board (IRB) Requirements, Medical Terminology, Microsoft Office, Oncology Treatment Trials, Phase I Clinical Trials

Preferred skills

• CRO or pharmaceutical CRA-only backgrounds are not preferred

Experience

• 2+ years