Senior Clinical Research Associate

Role Summary

Senior Clinical Research Associate (SCRA) responsible for monitoring assigned clinical study sites to ensure data quality and patient safety in accordance with ICH-GCP guidelines, local regulations, and SOPs. Collaborates with Clinical Study Teams, mentors CRAs, and seeks opportunities to improve site management and study delivery across the Americas region.

Responsibilities

• Perform and coordinate clinical monitoring activities to assess safety and efficacy of investigational products or medical devices per GCPs and SOPs
• Conduct site visits to verify protocol and regulatory compliance and prepare documentation
• Develop collaborative relationships with investigative sites and study vendors
• Track enrollment and study-specific status reports to ensure milestones are met
• Mentor/trainer for less experienced CRAs; assist with monitoring visit report reviews and managerial tasks
• Provide study-specific training and develop monitoring tools for efficient data review
• Perform SAE reconciliation and resolve discrepancies with sites and CRAs
• Review outstanding data reports to ensure data collection aligns with contractual guidelines
• Work with CTOMs and CST to manage site trends via dashboards and risk assessments
• Collaborate with CST and sites to ensure timely milestones (startup, recruitment, analyses, closeout)
• Support audits/inspections preparation and follow-up; address quality issues and findings
• Assist with other clinical responsibilities to support junior staff

Qualifications

• Understand clinical trial processes with knowledge of ICH guidelines
• Minimum 4–6 years of relevant Clinical Operations experience
• Minimum 3–4 years of CRA monitoring experience in pharma or CRO
• Excellent communication, interpersonal, and organizational skills
• Ability to prioritize and multi-task

Skills

• Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook
• Familiarity with industry CTMS and data management systems

Education

• BS/BA in a relevant scientific discipline; 4–6 years of Clinical Operations experience and 3–4 years of monitoring experience; global oncology trials preferred

Additional Requirements

• Travel up to 40–60% time