Clinical Research Associate I/II/Sr.

Live Well Homecare; Shanghai (VA); On-site; USD 65,000 - 90,000; Full time

Job summary

Live Well Homecare is seeking a Clinical Research Associate to oversee site management and monitoring of clinical studies in full compliance with ICH GCP and SOPs. Responsibilities include site visits, source data verification, regulatory document review, and ensuring data integrity and audit readiness.

The role requires a university degree or healthcare certification and 1.5 years external or 1 year internal monitoring experience, with travel up to 60%.

Qualifications

• University degree or healthcare certification required.
• Minimum 1.5 years external candidates or 1 year internal in clinical monitoring.
• Strong knowledge of ICH GCP and regulatory compliance.
• Ability to travel up to 60%.

Responsibilities

• Perform site visits (Pre-study, Initiation, Monitoring, Close-out) and monitor progress.
• Verify source documents and protect subject safety and data integrity.
• Review regulatory documents and maintain audit readiness.
• Track investigational product inventory and study materials.
• Support study team, manage trial systems, and ensure timelines and deliverables.

Skills

Clinical monitoring

GCP knowledge

Regulatory compliance

Project coordination

Travel readiness

Education

University degree or healthcare certification

Job description

This role involves site management and clinical monitoring responsibilities for clinical studies, ensuring adherence to ICH GCP guidelines, SOPs, and regulatory requirements.

Key duties include conducting site visits (Pre-study, Initiation, Monitoring, Close-out), verifying subject protection, reviewing source documents, managing regulatory documents, and ensuring data integrity and audit readiness.

The role also requires tracking investigational product inventory, supporting study team activities, managing trial systems, and ensuring study timelines and deliverables are met. The position may involve training, site initiation, and participating in meetings.

Qualifications include a university degree or healthcare certification, with a minimum of 1.5 years of clinical monitoring experience for external candidates or 1 year for internal candidates. Knowledge of ICH GCP, monitoring procedures, and regulatory compliance is essential.

Preferred skills encompass Phase I monitoring, life sciences background, strong organizational and communication skills, proficiency in clinical systems, and the ability to work independently. Physical demands include prolonged computer use and travel up to 60% of the time.

Candidates should demonstrate attention to detail, problem-solving abilities, confidentiality, and effective teamwork to succeed in this role.