Clinical Research Associate 3 (537238)

Key Responsibilities

• Act as the primary sponsor representative for assigned investigative sites, providing oversight of site performance, protocol adherence, and overall study conduct throughout the clinical trial lifecycle.
• Perform on-site and remote monitoring activities for Phase 1 oncology studies, including site qualification, site initiation, interim monitoring, and closeout visits, in accordance with study monitoring plans, sponsor SOPs, ICH/GCP guidelines, and regulatory requirements.
• Oversee critical study activities, including informed consent, eligibility verification, treatment administration, dose-escalation decisions, safety reporting, investigational product accountability, protocol deviation management, and data quality review.
• Assess site performance, operational readiness, and quality trends through monitoring observations, site interactions, and study metrics to proactively identify emerging risks and areas requiring intervention.
• Escalate significant compliance, quality, and operational issues in a timely manner and partner with Clinical Trial Managers and study teams to implement effective mitigation and corrective action plans.
• Collaborate closely with CRO personnel, vendors, medical monitors, pharmacovigilance, data management, clinical scientists, and study management teams to ensure alignment on study priorities, site status, and issue resolution.
• Provide oversight of CRO-delivered monitoring activities, including evaluation of monitoring quality, timeliness of follow-up, issue escalation practices, and adequacy of corrective actions.
• Review source-level and site-level information to verify that subject safety, protocol compliance, and study endpoints are being appropriately managed, particularly within complex early-phase oncology environments.
• Support study start-up and site management efforts through feasibility assessments, activation readiness, site training, enrollment oversight, and ongoing site engagement.
• Track and drive resolution of critical site issues, protocol deviations, data queries, action items, and inspection readiness activities while ensuring appropriate documentation and stakeholder communication.
• Prepare, review, and maintain monitoring reports, follow-up correspondence, and sponsor oversight documentation to ensure accuracy, completeness, and regulatory compliance.
• Contribute to audit and inspection readiness by ensuring monitoring and oversight activities are well documented and that identified risks and findings are appropriately trended, escalated, and resolved.
• Develop and maintain strong working relationships with investigators, research nurses, study coordinators, pharmacists, and site leadership while promoting accountability for quality and performance.
• Leverage oncology monitoring expertise to evaluate patient safety considerations, protocol complexity, site capabilities, and operational execution across Phase 1 and other early-stage oncology trials.
• Apply experience with NCI-sponsored studies, cooperative group trials, or federally funded oncology research programs to effectively navigate complex academic and institutional research environments.
• Travel regularly to investigative sites to support sponsor monitoring, oversight, and relationship management activities.

Qualifications & Experience

• Required Qualifications:
• Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or a related scientific discipline preferred.
• Minimum of five (5) years of clinical monitoring experience with significant oncology monitoring expertise.
• Direct Phase 1 oncology monitoring experience required, including dose-escalation studies, complex eligibility reviews, safety assessments, and early-phase clinical operations.
• Comprehensive knowledge of ICH/GCP guidelines, FDA regulations, and sponsor oversight requirements.
• Demonstrated ability to identify, assess, and escalate risks related to patient safety, data integrity, protocol compliance, and study quality.
• Experience with electronic data capture (EDC) systems, CTMS, eTMF platforms, and clinical trial tracking tools.
• Strong analytical, problem-solving, organizational, and critical-thinking skills.
• Excellent written and verbal communication skills with the ability to clearly communicate findings, risks, and recommendations to diverse stakeholders.
• Prioritization of managing complex issues through resolution while maintaining inspection-ready study conduct.
• Ability and willingness to travel regularly for site monitoring and sponsor oversight activities.
• Preferred Qualifications:
• Previous sponsor-side or sponsor-dedicated CRA experience with demonstrated ability to operate from a sponsor oversight perspective.
• Experience monitoring NCI-sponsored studies, cooperative group trials, academic oncology networks, or federally funded oncology research programs.
• Experience collaborating with CRO partners and cross-functional teams in a matrix environment.
• Ability to influence stakeholders, foster collaboration, and drive accountability across multiple study partners.