Early-Development Clinical Research Associate (Phase I/II) — Onsite Monitoring

ICON Strategic Solutions; United States; Presencial; USD 70.000 - 90.000; Jornada completa

Descripción de la vacante

ICON Strategic Solutions is seeking a Clinical Research Associate for early development programs in the US. You will act as the main liaison between investigational sites and sponsors, performing site visits from initiation to close-out, and ensuring strict ICH-GCP compliance and accurate CTMS/eTMF documentation.

We value collaboration and a sponsor-dedicated model, with global expertise supporting career development in a stable environment helping advance patient therapies.

Formación

• Bachelor’s degree in Life Sciences or equivalent or RN qualification.
• Eligible to work in United States without visa sponsorship.
• 2+ years of on-site monitoring experience in pharma/CRO.
• Experience monitoring Phase I/II trials.
• Proficient in ICH-GCP and CTMS/eTMF.

Responsabilidades

• 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 and track site staff training and maintain compliance records.
• Monitor patient safety with AE/SAE/PQC reporting.
• Support subject recruitment and retention at the site level.
• Oversee drug accountability and proper storage/destruction.
• Resolve data queries and drive high-quality data entry.
• Document site progress and elevate risks to the clinical team.

Educación

Bachelor’s degree in Life Sciences or equivalent

Qualified RN

Descripción del empleo

ICON Strategic Solutions is seeking a Clinical Research Associate for early development programs in the US. You will act as the main liaison between investigational sites and sponsors, performing site visits from initiation to close-out, and ensuring strict ICH-GCP compliance and accurate CTMS/eTMF documentation.

We value collaboration and a sponsor-dedicated model, with global expertise supporting career development in a stable environment helping advance patient therapies.