Senior Clinical Research Associate (CRA) – Remote

Parexel; Baton Rouge (LA); Remote; USD 60,000 - 90,000; Full time

Job summary

Parexel is seeking a CRA/Sr CRA in the United States to lead site monitoring and study delivery with close collaboration to the Local Study Team. The role involves initiation, monitoring, data management, and regulatory compliance to ensure study commitments are met.

The candidate will perform on-site and remote monitoring, support site staff, maintain CTMS data, and ensure timely SAEs reporting and inspections readiness across assigned sites.

Qualifications

• Excellent knowledge of ICH-GCP, basic GMP/GDP.
• Good knowledge of local regulations.
• Good medical knowledge and ability to learn client therapeutic areas.
• Basic understanding of the drug development process.
• Understanding of clinical study management including monitoring and data management.

Responsibilities

• Conduct monitoring visits (remote and onsite) per Monitoring Plan.
• Update CTMS and site communications to ensure timely data.
• Manage start-up, regulatory submissions, and site qualifications.
• Train, support, and advise investigators and staff on study-related matters.
• Ensure timely reporting of SAEs and quality issues; maintain inspection readiness.

Skills

Attention to detail

Communication skills

Collaboration

Negotiation

English proficiency

Local language fluency

Education

Bachelor's degree in life science or related field

Job description

Parexel is seeking a CRA/Sr CRA in the United States to lead site monitoring and study delivery with close collaboration to the Local Study Team. The role involves initiation, monitoring, data management, and regulatory compliance to ensure study commitments are met.

The candidate will perform on-site and remote monitoring, support site staff, maintain CTMS data, and ensure timely SAEs reporting and inspections readiness across assigned sites.