Lead CRA: Mentorship & Risk-Based Site Monitoring

Jazz Pharmaceutical; United States; On-site; USD 122,000 - 182,000; Full time

Job summary

Jazz Pharmaceuticals is seeking a Lead Clinical Research Associate to independently oversee on-site and remote monitoring for a portfolio of Jazz-sponsored trials, serving as a subject-matter expert and escalation point for site-level issues.

You will mentor CRAs and CRO staff, partner with Central Monitoring and Trial Risk Management, ensure ICH-GCP compliance, and help drive site readiness, data quality, and timely issue resolution across multiple sites and studies.

Qualifications

• 6+ years of clinical monitoring experience in the pharmaceutical, biotechnology, or CRO industry, including mentoring or leading other CRAs.
• Thorough working knowledge of ICH-GCP, global regulations, RBQM principles.
• Experience with risk-based monitoring using KRIs and QTLs.
• Proficiency with CTMS, eTMF, EDC, and remote monitoring platforms.
• Therapeutic area experience in oncology and/or neuroscience preferred.
• Strong written and verbal communication skills.

Responsibilities

• Independently perform and oversee on-site and remote monitoring visits in accordance with the monitoring plan, SOPs, and ICH-GCP.
• Serve as primary contact and escalation path for a defined group of CRAs; identify and resolve site performance and data quality issues.
• Interpret KRIs and centralized analytics to implement risk-based actions at the site level.
• Provide day-to-day guidance, mentorship, and in-field co-monitoring to CRAs and CRO staff.
• Oversee monitoring visits for CRO-staff and evaluate vendor performance.
• Review monitoring visit reports and ensure audit-ready documentation.
• Support site start-up activities and regulatory document collection.
• Ensure timely resolution of data queries and protocol deviations in collaboration with sites, DM, and Biostatistics.
• Maintain TMF oversight and inspection readiness.
• Lead the development of monitoring plans and site management tools.
• Support recruitment strategies by monitoring enrollment trends.

Job description

Jazz Pharmaceuticals is seeking a Lead Clinical Research Associate to independently oversee on-site and remote monitoring for a portfolio of Jazz-sponsored trials, serving as a subject-matter expert and escalation point for site-level issues.

You will mentor CRAs and CRO staff, partner with Central Monitoring and Trial Risk Management, ensure ICH-GCP compliance, and help drive site readiness, data quality, and timely issue resolution across multiple sites and studies.