Phase I Clinical Research Associate, Early Development

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

Benefits offered by this job

Equal opportunity employer

Job summary

IQVIA is seeking a Clinical Research Associate (CRA) to join our Early Clinical Development team across the West and East Coasts, focusing on Phase I trials. The CRA will monitor sites to ensure protocol compliance, regulatory adherence, and data integrity.

You will conduct site visits, train site staff, manage enrollments, and collaborate with cross-functional teams to support study execution. Travel will be required, and a life sciences degree with on-site monitoring experience is essential.

Qualifications

• Bachelor’s degree in life sciences or 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 all types of site visits—selection, initiation, monitoring, and close-out in alignment with the contracted scope of work, Good Clinical Practice (GCP), and ICH guidelines.
• Collaborate with site staff to implement and track subject recruitment strategies that align with project timelines and enrollment goals.
• Deliver protocol and study-specific training to site personnel and maintain consistent communication to manage expectations and resolve issues.
• Assess site performance and adherence to the protocol, escalating quality concerns as needed to ensure compliance and data integrity.
• Monitor study progress by tracking regulatory submissions, subject enrollment, case report form (CRF) completion, and resolution of data queries.
• Ensure that essential documents are collected and maintained in both the Trial Master File (TMF) and the Investigator Site File (ISF) in accordance with regulatory standards.
• Document site management activities, visit outcomes, and follow-up actions through detailed reports and correspondence.
• Work closely with cross-functional project teams to support study execution and ensure alignment with project goals.
• Depending on the project, you may also support site-level recruitment planning and financial management, including invoice collection and budget tracking.

Skills

GCP knowledge

ICH guidelines

On-site monitoring

Travel willingness

Education

Bachelor’s degree in life sciences or health-related field

Job description

IQVIA is seeking a Clinical Research Associate (CRA) to join our Early Clinical Development team across the West and East Coasts, focusing on Phase I trials. The CRA will monitor sites to ensure protocol compliance, regulatory adherence, and data integrity.

You will conduct site visits, train site staff, manage enrollments, and collaborate with cross-functional teams to support study execution. Travel will be required, and a life sciences degree with on-site monitoring experience is essential.