Senior CRA: Lead Site Monitoring & Start-Up

Sunseeker Property Service; Chicago (IL); On-site; USD 90,000 - 130,000; Full time

Job summary

Alexion seeks a Senior Clinical Research Associate (Sr. CRA) to oversee monitoring activities at allocated sites and act as the primary site contact. You will collaborate with PMCO, SSU, CSA and COM teams to ensure study commitments are met in-country.

The role covers site selection, initiation, monitoring, and closeout visits (remote and onsite), with a focus on timely data delivery, quality, and regulatory compliance in line with ICH-GCP and local requirements.

Qualifications

• Minimum of 4 years of CRA monitoring experience.
• Bachelor's degree in life science or related discipline.
• Excellent knowledge of ICH-GCP and local regulations.
• Good understanding of the drug development process and study management.

Responsibilities

• Perform site selection, initiation, monitoring and closeout visits (remote and onsite).
• Drive site performance and timely issue resolution.
• Train and advise Investigators and site staff on study matters and RBQM principles.
• Develop recruitment plans and support enrollment to meet milestones.
• Ensure QC checks of eTMF and timely regulatory submissions.
• Collaborate with PMCO, SSU, CSA and other stakeholders.

Skills

CRA monitoring

ICH-GCP

Regulatory compliance

Site management

Travel readiness

Education

Bachelor's degree in life sciences

Tools

CTMS

Job description

Alexion seeks a Senior Clinical Research Associate (Sr. CRA) to oversee monitoring activities at allocated sites and act as the primary site contact. You will collaborate with PMCO, SSU, CSA and COM teams to ensure study commitments are met in-country.

The role covers site selection, initiation, monitoring, and closeout visits (remote and onsite), with a focus on timely data delivery, quality, and regulatory compliance in line with ICH-GCP and local requirements.