Clinical Research Associate 3

Responsibilities

• Serve as the sponsor-side point of contact for assigned sites, providing direct oversight of site performance, protocol execution, and overall study conduct throughout the trial lifecycle.
• Conduct on-site and remote monitoring activities for Phase 1 oncology studies, including site qualification, initiation, routine monitoring, and closeout visits, in alignment with the monitoring plan, sponsor SOPs, ICH/GCP, and applicable regulations.
• Provide sponsor oversight of critical study processes, including informed consent, eligibility confirmation, treatment administration, dose-escalation decisions, safety reporting, investigational product handling, protocol deviations, and data quality.
• Evaluate site performance, operational readiness, and quality trends using monitoring observations, study metrics, and site interactions to identify actual or emerging risks.
• Escalate significant site issues, quality concerns, and compliance risks in a timely manner, and partner with the Clinical Trial Manager and broader study team on mitigation strategies and follow-up actions.
• Collaborate closely with CRO monitors, vendors, data management, medical monitoring, pharmacovigilance, clinical scientists, and study management to ensure alignment on site status, issues, and study priorities.
• Provide sponsor-level oversight of CRO-delivered monitoring activities, as applicable, including review of monitoring quality, timeliness of follow-up, issue escalation, and adequacy of site action plans.
• Review source-oriented and site-level information to confirm that subject safety, protocol compliance, and key study endpoints are being managed appropriately, with particular attention to the complexity of early-phase oncology trials.
• Support study start-up and maintenance activities by contributing to site feasibility, site activation readiness, training, enrollment oversight, and ongoing site engagement.
• Track and follow critical site issues, protocol deviations, data queries, action items, and inspection readiness activities to resolution, ensuring appropriate documentation and communication across stakeholders.

Qualifications

• Bachelor’s degree in life sciences, nursing, pharmacy, or a related scientific field preferred.
• Minimum of 5 years of clinical monitoring experience, with strong oncology monitoring experience required. Direct Phase 1 oncology monitoring experience is required, including experience with dose-escalation studies, complex eligibility and safety assessments, and early-phase operational challenges.
• Prior experience in a sponsor-side or sponsor-dedicated CRA role is preferred; candidates should demonstrate the ability to operate with a sponsor mindset and exercise sound judgment beyond routine monitoring activities.
• Experience monitoring NCI-sponsored studies, cooperative group studies, or academic oncology research networks is preferred.
• Strong working knowledge of ICH/GCP guidelines, FDA regulations, and sponsor oversight expectations, including the ability to recognize and escalate risks related to subject safety, data integrity, and protocol compliance.
• Experience working with CRO partners and cross-functional study teams, with the ability to communicate clearly, influence effectively, and drive issue resolution across multiple stakeholders.