Clinical Research Coordinator

Leading university (Palo Alto, CA 94304) — Hybrid worksite. W2 employment, 40 hours/week, 6‑month assignment with possibility of extension.

About the role

Manage clinical research activities and support oncology treatment studies, overseeing study operations from participant recruitment through data management, regulatory compliance, and sponsor coordination.

Responsibilities

• Oversee subject recruitment and enrollment goals, determining effective strategies for recruiting participants and retaining them in long‑term clinical trials.
• Oversee data management by developing and managing systems to organize, collect, report, and monitor data; extract, analyze, and interpret study data.
• Develop project schedules, targets, measurements, and accountabilities; lead team meetings and prepare or approve minutes.
• 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.
• 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; invoice sponsors according to the study contract.

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 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.

Benefits

• Group Medical, Dental, Vision
• Life insurance
• Retirement Savings Program
• Paid Sick Leave (PSL)

Pay

Hourly rate: $45–$50/hr

Schedule

• Full‑time, 40 hours/week
• Hybrid: onsite 4 days/week during training, then 3–4 days/week
• Day shift