Clinical Research Associate, IQVIA Biotech

Lifelancer
Philadelphia, PA
Category Healthcare
Job Description
IQVIA Biotech is hiring a Clinical Research Associate (CRA) to join their team and play a key role in ensuring the successful execution of clinical trials. The successful candidate will be responsible for monitoring and managing clinical sites to ensure compliance with study protocols, regulatory requirements, and sponsor expectations.

Requirements

  • 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.
  • Support site-level recruitment planning and financial management, including invoice collection and budget tracking, depending on the project.

Benefits

  • Generous Paid Time Off
  • 401k Matching
  • Retirement Plan
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