CRA II: On-Site Monitoring & Compliance Expert

KCR Placement; Orlando (FL); Vor Ort; USD 70.000 - 95.000; Vollzeit

Benefits dieser Stelle

Annual leave entitlements

Health insurance

Competitive retirement planning

Global Employee Assistance Programme

Life assurance

Country-specific optional benefits

Zusammenfassung

ICON Strategic Solutions in Orlando, FL is seeking a Clinical Research Associate to join a sponsor-dedicated model. You will conduct site visits, ensure site compliance with ICH-GCP, and maintain CTMS/eTMF documentation to support high-quality data and patient safety.

The ideal candidate has a Life Sciences degree or is a qualified RN, 2+ years of on-site monitoring experience, and must be willing to travel up to 60%–75% across the southeast region, with Orlando as a regional travel base.

Qualifikationen

• 2+ years of on-site monitoring experience in pharma or CRO
• Proficient in ICH-GCP and regulatory requirements
• Experience monitoring across multiple therapeutic areas
• Clear communicator, problem-solver, team player

Aufgaben

• Serve as the primary point of contact between investigational sites and the sponsor
• Conduct site visits including selection, initiation, routine monitoring and close-out
• Ensure site compliance with ICH-GCP, SOPs, and regulations
• Maintain up-to-date documentation in CTMS and eTMF systems
• Support site staff training and maintain compliance records
• Monitor patient safety and AE/SAE/PQC reporting
• Support subject recruitment and retention at the site level
• Oversee drug accountability and storage, return or destruction
• Resolve data queries and drive high-quality data entry
• Document site progress and escalate risks or issues to the clinical team
• Assist in tracking site budgets and payments
• Collaborate with cross-functional partners (CTAs, LTMs, CTMs)

Kenntnisse

On-site monitoring

Clinical research

Travel readiness

Communication skills

Ausbildung

Bachelor’s degree in Life Sciences

Qualified RN

Tools

CTMS

eTMF

Jobbeschreibung

ICON Strategic Solutions in Orlando, FL is seeking a Clinical Research Associate to join a sponsor-dedicated model. You will conduct site visits, ensure site compliance with ICH-GCP, and maintain CTMS/eTMF documentation to support high-quality data and patient safety.

The ideal candidate has a Life Sciences degree or is a qualified RN, 2+ years of on-site monitoring experience, and must be willing to travel up to 60%–75% across the southeast region, with Orlando as a regional travel base.