Phase I CRA – Early Clinical Development

IQVIA; Philadelphia (Philadelphia County); On-site; USD 90,000 - 175,000; Full time

Job summary

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

As a CRA, you will monitor and manage clinical sites to ensure protocol compliance, regulatory requirements, and sponsor expectations, contributing to data integrity and trial success. Travel will be required; collaboration with cross-functional teams is integral.

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 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

On-site monitoring experience

GCP/ICH knowledge

Regulatory compliance understanding

Travel readiness

Education

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

Job description

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

As a CRA, you will monitor and manage clinical sites to ensure protocol compliance, regulatory requirements, and sponsor expectations, contributing to data integrity and trial success. Travel will be required; collaboration with cross-functional teams is integral.