Clinical Research Associate II - Oncology

for site selection, initiation, monitoring, and close-out activities for investigational sites. This includes conducting routine site visits to verify data accuracy, ensuring proper source document review, assessing patient safety, and managing investigational product accountability. You will serve as the primary point of contact for study sites, providing guidance and support to investigators and site staff. A critical aspect of this role involves ensuring compliance with Good Clinical Practice (GCP) guidelines and all applicable regulations. The ideal candidate will possess strong organizational skills, excellent communication abilities, and a thorough understanding of clinical trial processes within the oncology therapeutic area. This is an on-site position located in Boise, Idaho, US , requiring regular travel to investigative sites within the assigned region. We are looking for a self-starter who can manage their workload efficiently and contribute positively to a high-performing clinical research team.

Responsibilities: Perform site selection, initiation, monitoring, and close-out visits for clinical trial sites. Verify the accuracy, completeness, and integrity of clinical data through source document verification. Ensure compliance with Good Clinical Practice (GCP), ICH guidelines, and all applicable regulatory requirements. Manage and maintain study-related documentation and essential trial documents. Act as the primary liaison between study sites, the sponsor, and internal study teams. Train and support site personnel on study protocols, procedures, and regulatory requirements. Monitor patient safety and safety reporting procedures at assigned sites. Oversee investigational product management and accountability at study sites. Resolve site-level issues and escalate critical findings to the Clinical Trial Manager as needed. Contribute to the development of study protocols, monitoring plans, and other study-related documents. Qualifications: Bachelor's degree in a life science, nursing, or a related field. Minimum of 3 years of direct clinical monitoring experience, with a strong preference for oncology trials. Demonstrated knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trials. Experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS). Excellent organizational, time management, and problem-solving skills. Strong written and verbal communication skills, with the ability to build rapport with site staff. Ability to travel frequently to clinical sites as required by the study. Proficiency in Microsoft Office Suite.