Senior CRA II - Site Monitoring & Data Integrity Lead

FTCHI Fortrea Chile Limitada; Santiago; On-site; CLP 24,000,000 - 42,000,000; Full time

Job summary

FTCHI Fortrea Chile Limitada in Santiago seeks an experienced Lead CRA to oversee site management for clinical studies under ICH GCP and Fortrea SOPs, including initiation, monitoring, and close-out visits. You will safeguard subjects, ensure data integrity, and regulatory compliance across trials.

The role requires a degree in a related health field, 2+ years of clinical monitoring experience, strong English and local language skills, and the ability to work with minimal supervision.

Qualifications

• Minimum required qualifications include a university or college degree in a related allied health field or nursing licensure.
• Thorough understanding of ICH GCP Guidelines and local regulatory requirements.
• Experience monitoring clinical trials and performing source data verification.

Responsibilities

• Lead CRA responsibilities for site monitoring across clinical trials with adherence to SOPs and GCP guidelines.
• Perform 100% source data verification, query resolution, and eCRF reviews as assigned.
• Prepare monitoring plans, site initiation slides, and trip reports.
• Ensure subject protection, proper informed consent, and protocol compliance at sites.
• Track IP shipments and manage trial materials per protocol.

Skills

ICH GCP knowledge

Clinical monitoring

English proficiency

Attention to detail

Problem solving

Communication skills

Education

University degree in a related allied health field

Tools

CTMS

eClinical systems

Microsoft Office

Job description

FTCHI Fortrea Chile Limitada in Santiago seeks an experienced Lead CRA to oversee site management for clinical studies under ICH GCP and Fortrea SOPs, including initiation, monitoring, and close-out visits. You will safeguard subjects, ensure data integrity, and regulatory compliance across trials.

The role requires a degree in a related health field, 2+ years of clinical monitoring experience, strong English and local language skills, and the ability to work with minimal supervision.