Remote Clinical Research Associate / Senior CRA

Parexel; Honolulu (HI); Remote; USD 90,000 - 130,000; Full time

Job summary

Parexel FSP is seeking a CRA/Sr CRA to support clinical studies in the United States. The role covers site initiation, monitoring, and closeout with responsibility for data integrity, regulatory compliance, and collaboration with local study teams.

Experience with ICH-GCP and site management is required. The incumbent will work with LSAD/CQM to ensure study milestones are met, manage CTMS updates and ensure timely reporting of SAEs, while maintaining inspection-ready documentation and site

Qualifications

• Excellent knowledge of ICH-GCP and regulatory requirements.
• Strong communication skills, both written and verbal.
• Ability to train and support investigators and site staff.
• Ability to manage multiple sites and monitor progress.

Responsibilities

• Perform site monitoring visits (remote and onsite) per Monitoring Plan.
• Prepare/execute site initiation, monitoring, and closeout activities.
• Update CTMS and other systems with site data.
• Ensure timely escalation of issues and risk-based monitoring decisions.
• Maintain inspection-ready ISF and coordination with LSAD and CQAD.

Skills

Attention to detail

Written & verbal communication

Collaboration & teamwork

Negotiation skills

English proficiency

Local language fluency

Education

Bachelor’s degree in life sciences or related field

Job description

Parexel FSP is seeking a CRA/Sr CRA to support clinical studies in the United States. The role covers site initiation, monitoring, and closeout with responsibility for data integrity, regulatory compliance, and collaboration with local study teams.

Experience with ICH-GCP and site management is required. The incumbent will work with LSAD/CQM to ensure study milestones are met, manage CTMS updates and ensure timely reporting of SAEs, while maintaining inspection-ready documentation and site