Clinical Research Coordinator 3

Avispa Technology•Palo Alto, CA

17d•Hybrid

About The Position

A leading university is seeking a Clinical Research Coordinator 3 to manage clinical research activities and support oncology treatment studies. The role oversees study operations from participant recruitment through data management, regulatory compliance, and sponsor coordination. This is a 6-month W2 assignment with the possibility of extension, working 40 hours per week at a hybrid worksite in Palo Alto, California. The schedule is a day shift, with onsite work 4 days per week during training and 3–4 days per week afterward.

Requirements

At least 2 years of clinical research experience, or an equivalent combination of education and relevant experience.
Bachelor's degree in a related field.
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.

Nice To Haves

Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ACRP) certification is preferred.

Responsibilities

Oversee subject recruitment and enrollment goals, developing strategies to recruit participants and retain them in long-term clinical trials.
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 meeting minutes.
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; and regularly inspecting study documents.
Work 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 and define 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.