Senior CRA, Phase 1 Early Clinical Development (East Coast)

IQVIA; Durham (NC); On-site; USD 87,000 - 169,000; Full time

Job summary

IQVIA Early Clinical Development in the United States is seeking a Senior Clinical Research Associate (CRA) I with Phase 1 experience across multiple therapeutic areas. The role focuses on monitoring and managing clinical sites to ensure protocol compliance and data integrity.

Ideal candidates will have at least 1.5 years of on‑site monitoring experience, strong GCP/ICH knowledge, and willingness to travel. This is a full‑time position supporting East Coast projects.

Qualifications

• Bachelor’s degree in life sciences or health‑related field or equivalent experience.
• Requires 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 site visits—selection, initiation, monitoring, and close‑out per scope, GCP, and ICH.
• Collaborate with site staff to implement recruitment strategies aligned with timelines.
• Deliver protocol training to site personnel and maintain regular communication.
• Assess site performance and escalate quality concerns for data integrity.
• Monitor study progress: regulatory submissions, enrollment, CRF completion, data queries.
• Ensure TMF and ISF documents comply with regulatory standards.
• Document site activities, visit outcomes, and follow‑up actions in reports.
• Work with cross‑functional teams to support study execution and alignment.
• Support site‑level recruitment planning and budget tracking as needed.

Skills

On-site monitoring experience

GCP/ICH knowledge

Travel readiness

Education

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

Job description

IQVIA Early Clinical Development in the United States is seeking a Senior Clinical Research Associate (CRA) I with Phase 1 experience across multiple therapeutic areas. The role focuses on monitoring and managing clinical sites to ensure protocol compliance and data integrity.

Ideal candidates will have at least 1.5 years of on‑site monitoring experience, strong GCP/ICH knowledge, and willingness to travel. This is a full‑time position supporting East Coast projects.