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Senior Clinical Research Associate, Early Clinical Development

$90.2k - $150.4k

IQVIA

IQVIA Biotech seeks a Clinical Research Associate 2 to monitor clinical trial sites and ensure protocol compliance, regulatory adherence, and data integrity. The role involves site management across multiple visit types, staff training, enrollment tracking, and regulatory documentation in early-phase studies.

Responsibilities

  • Conduct site selection, initiation, monitoring, and close-out visits aligned with GCP and ICH guidelines
  • Collaborate with site staff on subject recruitment strategies to meet enrollment timelines and goals
  • Provide protocol training to site personnel and maintain ongoing communication
  • Monitor protocol adherence, escalate quality concerns, and track regulatory submissions and data query resolution
  • Maintain Trial Master Files and Investigator Site Files with essential regulatory documents

Requirements

  • Bachelor's degree in life sciences or health-related field
  • Minimum 1.5 years of onsite monitoring experience
  • Strong knowledge of GCP, ICH guidelines, and regulatory requirements
  • Ability to travel as required by assigned projects
  • Early phase clinical development experience preferred

Compensation: $90,200.00 - $150,400.00 base

Vacancy posted a month ago
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