Senior CRA, Phase I Early Development (West Coast)

IQVIA; Carlsbad (CA); On-site; USD 90,000 - 175,000; Full time

Job summary

IQVIA LLC on the West Coast seeks a Senior Clinical Research Associate to monitor Phase I trials and ensure site compliance with study protocols and regulatory requirements. You will manage site visits, communications, and data integrity to support successful trial execution.

The role requires at least 1.5 years of on-site monitoring experience, a life sciences degree, and the ability to travel as needed. You will work with cross-functional teams to ensure alignment with project timelines and

Qualifications

• Bachelor's degree in life sciences or health-related field.
• At least 1.5 years of on-site monitoring experience.
• Strong understanding of GCP, ICH guidelines, and regulatory requirements.
• Ability to travel as required.

Responsibilities

• Conduct on-site visits including initiation, monitoring, and close-out in line with GCP/ICH.
• Collaborate with site staff to support recruitment timelines and targets.
• Deliver protocol-specific training to site personnel and communicate clearly.
• Assess site performance and escalate quality issues to ensure data integrity.
• Track regulatory submissions, subject enrollment, CRF completion, and data queries.
• Maintain TMF and ISF documentation per regulatory standards.
• Document site activities and follow-up actions in detailed reports.
• Support cross-functional teams to align study execution and budgets.

Skills

GCP/ICH knowledge

On-site monitoring

Travel readiness

Regulatory compliance

Education

Bachelor’s degree in life sciences

Job description

IQVIA LLC on the West Coast seeks a Senior Clinical Research Associate to monitor Phase I trials and ensure site compliance with study protocols and regulatory requirements. You will manage site visits, communications, and data integrity to support successful trial execution.

The role requires at least 1.5 years of on-site monitoring experience, a life sciences degree, and the ability to travel as needed. You will work with cross-functional teams to ensure alignment with project timelines and