Sr. CRA, Sponsor Aligned, Oncology

Lifelancer
Overland Park, KS
Category Healthcare
Job Description
Join our dynamic team as a Clinical Research Associate! You’ll play a pivotal role in monitoring and managing clinical trial sites to ensure compliance with study protocols, regulations, and sponsor requirements. Be at the forefront of groundbreaking cancer research and make a real impact on patients’ lives.

Requirements

  • Site Monitoring Visits: Conduct selection, initiation, monitoring, and close-out visits in line with GCP and ICH guidelines.
  • Subject Recruitment: Collaborate with sites to develop and track recruitment plans, ensuring project needs are met.
  • Training & Communication: Provide protocol and study training to sites, maintaining regular communication to manage expectations and address issues.
  • Quality Assurance: Assess site practices for protocol adherence and regulatory compliance, escalating quality issues as needed.
  • Study Progress Management: Oversee regulatory submissions, recruitment, enrollment, CRF completion, and data query resolution. Support start-up phases as required.
  • Documentation: Ensure all site documents are filed in the Trial Master File (TMF) and Investigator’s Site File (ISF) per GCP/ICH and local regulations.
  • Reporting: Generate visit reports, follow-up letters, and other necessary documentation.
  • Mentorship: Mentor clinical staff through co-monitoring and training visits.
  • Collaboration: Work closely with study team members to support project execution.
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