Clinical Research Associate, Early Clinical Development

IQVIA•Durham, NC

1d•$90,200 - $175,100•Remote

About The Position

IQVIA is seeking a dedicated Clinical Research Associate (CRA) to join their growing Early Clinical Development team, focusing exclusively on Phase I trials. The CRA will play a key role in ensuring the successful execution of clinical trials by monitoring and managing clinical sites to ensure compliance with study protocols, regulatory requirements, and sponsor expectations. This role directly contributes to the integrity and quality of clinical research data.

Requirements

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.