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IQVIA · 1 day ago

Sr. CRA, Sponsor Aligned, Oncology

Overland Park, KS

Full-time

Onsite

Mid, Senior Level

$58K/yr - $227K/yr

3+ years exp

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. The Clinical Research Associate will monitor and manage clinical trial sites, ensuring compliance with study protocols and regulations while contributing to groundbreaking cancer research.

AnalyticsHealth CareLife Science

Responsibilities

Conduct selection, initiation, monitoring, and close-out visits in line with GCP and ICH guidelines

Collaborate with sites to develop and track recruitment plans, ensuring project needs are met

Provide protocol and study training to sites, maintaining regular communication to manage expectations and address issues

Assess site practices for protocol adherence and regulatory compliance, escalating quality issues as needed

Oversee regulatory submissions, recruitment, enrollment, CRF completion, and data query resolution

Ensure all site documents are filed in the Trial Master File (TMF) and Investigator’s Site File (ISF) per GCP/ICH and local regulations

Generate visit reports, follow-up letters, and other necessary documentation

Mentor clinical staff through co-monitoring and training visits

Work closely with study team members to support project execution

Qualification

Oncology monitoring experiencePhase 1 oncology experienceGCPICH guidelinesTherapeuticProtocol knowledgeMicrosoft Office proficiencyEffective communicationOrganizational skillsProblem-solving abilitiesTime management skillsRelationship building