Clinical Research Associate, Early Clinical Development

IQVIA • Carlsbad, CA

4d

About The Position

IQVIA is hiring Clinical Research Associates on the West Coast and East Coast of the United States to join its Early Clinical Development team, working exclusively on Phase I studies. The Clinical Research Associate monitors and manages clinical sites to ensure that trials comply with study protocols, regulatory requirements, Good Clinical Practice (GCP), ICH guidelines, and sponsor expectations. The role supports the integrity and quality of clinical research data and successful study execution.

The position involves site visits, site staff training and communication, monitoring study progress and site performance, maintaining essential study documents, and collaborating with cross-functional project teams. Depending on the project, the CRA may also assist with site-level recruitment planning and financial management. Travel is required as dictated by project needs.

Requirements

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

Responsibilities

• Conduct site selection, initiation, monitoring, and close-out visits in accordance with the contracted scope of work, GCP, and ICH guidelines.
• Collaborate with site staff to implement and track subject recruitment strategies aligned with project timelines and enrollment goals.
• Provide protocol and study-specific training to site personnel, maintain communication, manage expectations, and resolve issues.
• Assess site performance and protocol adherence, escalating quality concerns as needed to ensure compliance and data integrity.
• Track regulatory submissions, subject enrollment, case report form (CRF) completion, and resolution of data queries.
• Ensure essential documents are collected and maintained in the Trial Master File (TMF) and Investigator Site File (ISF) in accordance with regulatory standards.
• Document site management activities, visit outcomes, and follow-up actions in reports and correspondence.
• Work with cross-functional project teams to support study execution and alignment with project goals.
• Depending on the project, support site-level recruitment planning and financial management, including invoice collection and budget tracking.

Benefits

• Health and welfare benefits may be offered.
• Incentive plans, bonuses, and/or other forms of compensation may be offered, depending on the position.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level