Clinical Research Coordinator 3

Clinical Research Coordinator 3 1519509

• Hourly pay: $45-$50/hr
• Worksite: Leading university (Palo Alto, CA 94304 - Hybrid)
• W2 Employment, Group Medical, Dental, Vision, Life, Retirement Savings Program, PSL
• 40 hours/week, 6 Month Assignment, (With possibility of extension)

A leading university is seeking a Clinical Research Coordinator 3 to manage clinical research activities and support oncology treatment studies, overseeing study operations from participant recruitment through data management, regulatory compliance, and sponsor coordination.

Clinical Research Coordinator 2 Responsibilities:

• Oversee subject recruitment and enrollment goals, determining effective strategies for recruiting participants and retaining them in long-term clinical trials, and oversee data management by developing and managing systems to organize, collect, report, and monitor data, and by extracting, analyzing, and interpreting study data.
• Develop project schedules, targets, measurements, and accountabilities, lead team meetings and prepare or approve minutes, and formally supervise, train, and mentor new staff or students, including hiring and preparing performance evaluations as assigned.
• Ensure regulatory compliance by auditing operations, including laboratory procedures, leading corrective actions, monitoring Institutional Review Board submissions and renewals, regularly inspecting study documents, and working with the principal investigator to submit Investigational New Drug applications to the FDA when applicable.
• Collaborate with principal investigators and study sponsors to monitor and report serious adverse events and resolve study queries, and lead improvements to policies and processes while defining best practices.
• Develop study budgets with staff and the principal investigator, identifying standard of care versus study procedures, track patient and study-specific milestones, and invoice sponsors according to the study contract.

Clinical Research Coordinator 2 Qualifications:

• 2+ years of clinical research experience, or an equivalent combination of education and relevant experience.
• Bachelor's degree in a related field.
• Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ACRP) certification is preferred.
• Experience as an onsite clinical research coordinator; data management, project management, or regulatory-only backgrounds are not preferred.
• Experience coordinating oncology treatment trials.
• Experience using EPIC electronic medical record systems.
• 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 and database applications.

Shift:

• Hybrid: onsite 4 days/week during training, then 3-4 days/week. Day shift.