Sr. Clinical Research Associate

Site Monitoring and Oversight

• Conduct site qualification, initiation, routine monitoring, remote monitoring, and close-out activities, as applicable.
• Ensure site compliance with the clinical trial protocol, monitoring plan, ICH-GCP requirements, applicable regulations, and company procedures.
• Review source documentation, informed consent documentation, eligibility confirmation, investigational product accountability, safety reporting, essential documents, and data quality.
• Identify site-level risks, document findings, and drive timely corrective and preventive actions.
• Maintain accurate, complete, and inspection-ready monitoring documentation and reports.

Enrollment and Site Performance

• Partner closely with investigators and site teams to improve study awareness, patient identification, screening, and enrollment.
• Develop site-specific action plans to address enrollment barriers and operational challenges.
• Monitor site performance using agreed metrics, including enrollment activity, screening patterns, data quality, issue resolution, and investigator engagement.
• Provide hands-on support to sites and proactively escalate risks that could affect study timelines or patient recruitment.
• Support evaluation and onboarding of additional sites based on enrollment potential, operational readiness, investigator engagement, hospital capacity, and activation feasibility.

Investigator and Site Relationship Management

• Establish trusted, productive relationships with principal investigators, study coordinators, research nurses, pharmacists, and other site stakeholders.
• Serve as a visible and responsive sponsor representative for assigned sites.
• Maintain frequent communication with site teams and provide timely follow-up on operational, clinical, and enrollment-related issues.
• Strengthen relationships with high-performing and high-potential research centers, particularly within the Midwest and other priority North American regions.
• Facilitate effective communication between sites and internal medical, clinical operations, data management, safety, and regulatory teams.

Suppliers and Cross-Functional Collaboration

• Work closely with the suppliers while maintaining clear accountability for Corxel-managed sites.
• Coordinate monitoring activities, issue escalation, data review, site communications, and operational handoffs with supplier teams.
• Participate in study team meetings and provide clear updates on site performance, enrollment progress, risks, and mitigation actions.
• Collaborate with internal and external stakeholders to ensure consistent execution across the broader North American site network.

Lead CRA Responsibilities

• Provide functional guidance, coaching, and day-to-day support to other CRAs.
• Promote consistent monitoring practices and quality standards across assigned sites.
• Review site performance trends and recommend prioritization or escalation strategies.
• Support monitoring-plan implementation, risk-based monitoring activities, and inspection-readiness initiatives.
• Coordinate regional coverage and help balance CRA workload across priority sites.
• Serve as a senior operational point of contact for complex site issues.
• Contribute to study-level planning, process improvement, and lessons learned.