Sr. Clinical Research Associate

Responsibilities

• Conduct remote and on-site visits (site assessment, initiation, routine monitoring, and close-out)
• Familiar with Risk Based Monitoring (RBM), verify source data, ensure ongoing subject safety review, and audit IP accountability per the monitoring plan
• Familiar with CAPA. prepares timely, accurate, and comprehensive monitoring visit reports
• Serve as the primary point of contact for investigators, study coordinators, vendors, and internal stakeholders, fostering effective communication and collaboration throughout the trial lifecycle
• Serve as a study lead CRA or regional lead CRA when assigned
• Care for site start-up, ongoing monitoring, and close-out activities, including regulatory document review and maintenance of study files
• Provide guidance and support to clinical sites on protocol implementation, regulatory requirements, and issue resolution
• Support study start-up and development activities, including review of protocols, Case Report Forms, and Informed Consent Forms, and contribution to monitoring strategies and investigator meetings
• Track study milestones, enrollment progress, and site activation timelines
• Develop and maintain study trackers, dashboards, and risk management tools
• Lead site performance reviews and identify sites requiring additional support or escalation
• Assist with the development, review, and maintenance of study documentation, including protocols, SOPs, training materials, and other essential trial documents
• Develop and deliver study-related training in alignment with company policies and SOPs to support consistent and compliant study execution
• Maintain systems and processes to track trial progress, report study status, and ensure clinical trials are conducted on time, within budget, and in compliance with regulatory standards
• Participate in ongoing clinical training and stay current on developments in clinical research and regulatory guidance
• Work independently while collaborating effectively within cross-functional teams; contribute to broader study management and process improvement initiatives as appropriate based on experience level
• Perform additional responsibilities as assigned
• Travel to clinical trial sites (including Midwest & Eastcoast) up to approximately 75% as required
• Support study forecasting, resource planning, and issue management
• Absorb and assist with inspection readiness activities and sponsor audits

Qualifications

• Education: Bachelor’s degree in a scientific discipline or healthcare-related field
• Experience: 5-8 years of clinical trial experience, including multi-site study management. Minimum 3–5 years of independent monitoring experience
• Technical Knowledge: Strong working knowledge of Good Clinical Practice (GCP) research standards, ICH guidelines, and applicable regulatory requirements
• Monitoring Skills: Intermediate to advanced clinical monitoring experience, including site initiation, routine monitoring, and close-out activities. Comprehensive understanding of Serious Adverse Event (SAE) reporting and follow-up requirements
• Systems Proficiency: Proficiency with clinical research systems, including Electronic Data Capture (EDC), Clinical Trial Management Systems (CTMS), Electronic Document Management Systems (EDMS), Microsoft Office applications (Excel, Word, PowerPoint, etc), Smartsheets
• Communication: Strong written and verbal communication skills with the ability to interact professionally and effectively with internal teams, investigators, and external partners