Clinical Research Associate (CRA)

Key Responsibilities

• Conduct remote and on-site monitoring visits in accordance with the monitoring plan, including site qualification, site initiation, routine monitoring, and close out activities
• Perform source data review (SDR) and verification (SDV) to ensure data accuracy, completeness, and alignment with our clinical trial protocols
• Ensure sites enter clinical data into applicable study systems within required timelines and support ongoing data cleaning activities, including query resolution, interim data reviews, and database lock readiness
• Assess site compliance with GCP, protocol requirements, institutional policies, and regulatory expectations
• Identify, document, and track protocol deviations, safety events/trends (AEs, SAEs, SUSARs, etc.), and data quality issues, escalating concerns as needed
• Evaluate site performance, enrollment progress, and readiness for key study milestones
• Support site training on protocol requirements, investigational product handling, and study procedures
• Complete monitoring visit reports within required timelines, issue timely follow up correspondence to clinical sites, and ensure resolution of outstanding action items and findings
• Study Conduct Support
• Assist Clinical Operations team with study level oversight of assigned sites
• Support study conduct across multiple site functions, including inpatient/outpatient care teams, apheresis centers, cell processing laboratories, local laboratories, and radiology departments, to ensure coordinated execution of protocol requirements
• As needed, support development, revision, and execution of study tools, checklists, training materials, and tracking documents
• Provide ongoing feedback on opportunities to streamline monitoring processes, reduce redundancy, and improve operational efficiency at the site level
• Cross Functional Collaboration
• Partner effectively with internal and external teams including Clinical Operations, Patient Operations, Clinical Development, Safety, Data Management, and Quality
• Engage with external stakeholders including CRO partners, vendors, and site staff to ensure smooth trial execution
• Provide timely updates on site status, risks, and action item resolution

Required Qualifications

• Bachelor’s degree in a scientific or health-related field
• Minimum 3 years of independent clinical trial monitoring experience within a CRO or sponsor environment, including experience monitoring Phase 2-3 clinical trials
• Current Good Clinical Practice (GCP) certification
• Strong understanding of ICH E6, FDA regulations, and clinical trial conduct
• Familiarity with common clinical trial systems including Electronic Data Capture (EDC), Clinical Trial Management Systems (CTMS), and vendor portals
• Excellent communication, organizational, and time management skills
• Willingness and ability to travel up to 75% for on-site monitoring visits (domestic travel; occasional short notice travel may be required)

Preferred Qualifications

• Prior oncology monitoring experience; pediatric or neuro-oncology exposure is a plus
• Experience in rare disease studies or high acuity patient populations
• Background in cell therapy or gene therapy trials, especially autologous programs
• Experience with risk-based monitoring (RBM) and targeted SDV models
• Familiarity with complex studies that include central imaging, chain of custody workflows, and/or time sensitive procedures
• Experience working in a fast-paced environment