Phase I Clinical Research Associate - Early Development

IQVIA; Durham (NC); On-site; USD 90,000 - 175,000; Full time

Job summary

IQVIA is now hiring for Clinical Research Associates located on the West Coast and East Coast, US to join our growing Early Clinical Development team working exclusively in Phase I.

As a CRA, you will monitor and manage clinical sites to ensure protocol compliance, regulatory adherence, and sponsor expectations, contributing to data integrity.

Qualifications include a bachelor’s degree in life sciences and at least 1.5 years of on-site monitoring experience; travel as required.

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 by the project.

Responsibilities

• Conduct site visits—selection, initiation, monitoring, and close-out per GCP/ICH.
• Collaborate with site staff to recruit subjects per timelines and enrollment goals.
• Provide protocol training to site personnel and maintain effective communication.
• Assess site performance and escalate quality concerns as needed.
• Monitor progress: regulatory submissions, enrollment, CRF completion, data queries.
• Maintain TMF and ISF documentation per regulatory standards.
• Document site activities, visit outcomes, and follow-up actions.
• Support cross-functional project teams to align with goals.
• Assist site-level recruitment planning and budget tracking when needed.

Skills

GCP & ICH knowledge

On-site monitoring

Travel willingness

Education

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

Job description

IQVIA is now hiring for Clinical Research Associates located on the West Coast and East Coast, US to join our growing Early Clinical Development team working exclusively in Phase I.

As a CRA, you will monitor and manage clinical sites to ensure protocol compliance, regulatory adherence, and sponsor expectations, contributing to data integrity.

Qualifications include a bachelor’s degree in life sciences and at least 1.5 years of on-site monitoring experience; travel as required.